TPLC - Total Product Life Cycle

• Device: system, image processing, radiological
• Regulation Description: Medical image management and processing system.
• Product Code: LLZ
• Regulation Number: 892.2050
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
3D ONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ABYS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ADAS3D MEDICAL S.L.
	SUBSTANTIALLY EQUIVALENT	3
ADVANTIS MEDICAL IMAGING SINGLE MEMBER P.C.
	SUBSTANTIALLY EQUIVALENT	2
AGFA HEALTHCARE N.V.
	SUBSTANTIALLY EQUIVALENT	1
AI MEDIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
AI MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	1
AI4MEDIMAGING MEDICAL SOLUTIONS S.A.
	SUBSTANTIALLY EQUIVALENT	1
AIBOLIT TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	2
AIKENIST TECHNOLOGIES PVT, LTD.
	SUBSTANTIALLY EQUIVALENT	1
AIQ GLOBAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
AIRAMED GMBH
	SUBSTANTIALLY EQUIVALENT	1
AIRS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
AKUNAH PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ANGIOCLOUD, LLC
	SUBSTANTIALLY EQUIVALENT	1
APOQLAR GMBH
	SUBSTANTIALLY EQUIVALENT	1
ARCHY DENTAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARGUS COGNITIVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARTERYFLOW TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ASPEN IMAGING HEALTHCARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ASSEMBLECIRCLE CORP.
	SUBSTANTIALLY EQUIVALENT	1
ATOMICA TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
AUGMENT INTELLIGENT MEDICAL SYSTEM (CHINA) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
AUGMENTED REALITY SOFTWARE S.L.
	SUBSTANTIALLY EQUIVALENT	1
AVATAR MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
AXIAL MEDICAL PRINTING LIMITED
	SUBSTANTIALLY EQUIVALENT	2
BB IMAGING
	SUBSTANTIALLY EQUIVALENT	2
BIOMET MANUFACTURING CORP
	SUBSTANTIALLY EQUIVALENT	1
BLUE BELT TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
BRAINLAB , LTD.
	SUBSTANTIALLY EQUIVALENT	1
BRAINLAB AG
	SUBSTANTIALLY EQUIVALENT	3
BRAINNOW MEDICAL TECHNOLOGY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
BRAINOMIX LIMITED
	SUBSTANTIALLY EQUIVALENT	3
BRAINSPEC, INC.
	SUBSTANTIALLY EQUIVALENT	1
CANON MEDICAL INFORMATICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CANON MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
CARDIO FLOW DESIGN, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARESTREAM HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARISTO DIAGNOSTICS , LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARL ZEISS MEDITEC, AG
	SUBSTANTIALLY EQUIVALENT	1
CARLSMED, INC.
	SUBSTANTIALLY EQUIVALENT	2
CARPL AI, INC.
	SUBSTANTIALLY EQUIVALENT	1
CEDARS-SINAI MEDICAL CENTER: AIM
	SUBSTANTIALLY EQUIVALENT	1
CERCARE MEDICAL A/S
	SUBSTANTIALLY EQUIVALENT	2
CERCARE MEDICAL APS
	SUBSTANTIALLY EQUIVALENT	1
CHANGE HEALTHCARE CANADA COMPANY
	SUBSTANTIALLY EQUIVALENT	1
CHANGE HEALTHCARE ISRAEL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
CIRCLE CARDIOVASCULAR IMAGING
	SUBSTANTIALLY EQUIVALENT	1
CIRCLE CARDIOVASCULAR IMAGING, INC.
	SUBSTANTIALLY EQUIVALENT	2
CLARIPI, INC.
	SUBSTANTIALLY EQUIVALENT	2
CLARITAS HEALTHTECH PTE, LTD.
	SUBSTANTIALLY EQUIVALENT	3
CLARUS VIEWER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
COMBINOSTICS OY
	SUBSTANTIALLY EQUIVALENT	1
CONVERGENT IMAGING SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
CORIN U.S.A. LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CUPTIMIZE, INC.
	SUBSTANTIALLY EQUIVALENT	1
CUSTOMSURG AG
	SUBSTANTIALLY EQUIVALENT	1
CYNCRONUS, LLC
	SUBSTANTIALLY EQUIVALENT	1
DDE MRI SOLUTIONS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
DEEPHEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEEPLOOK, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEEPTEK MEDICAL IMAGING PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
DENTI.AI TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
DICOM GRID DBA AMBRA HEALTH
	SUBSTANTIALLY EQUIVALENT	1
DISIOR, LTD.
	SUBSTANTIALLY EQUIVALENT	1
DOSISOFT SA
	SUBSTANTIALLY EQUIVALENT	1
DRTECH CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
DURR DENTAL SE
	SUBSTANTIALLY EQUIVALENT	1
DYAD MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ELEKTA SOLUTIONS AB
	SUBSTANTIALLY EQUIVALENT	1
ELUCID BIOIMAGING, INC.
	SUBSTANTIALLY EQUIVALENT	2
EOS IMAGING
	SUBSTANTIALLY EQUIVALENT	1
ERAD, INC.
	SUBSTANTIALLY EQUIVALENT	1
EVER FORTUNE.AI, CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
EVERRTECH SOFTWARE PVT, LTD.
	SUBSTANTIALLY EQUIVALENT	1
EVOLVE PACS, INC.
	SUBSTANTIALLY EQUIVALENT	1
EWOOSOFT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	10
EXINI DIAGNOSTICS AB
	SUBSTANTIALLY EQUIVALENT	2
EXOCAD GMBH
	SUBSTANTIALLY EQUIVALENT	1
EZRA AI, INC.
	SUBSTANTIALLY EQUIVALENT	1
FH INDUSTRIE
	SUBSTANTIALLY EQUIVALENT	1
FOVIA, INC.
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	3
GE HEALTHCARE GMBH
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS SCS
	SUBSTANTIALLY EQUIVALENT	5
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
HDX WILL CORP.
	SUBSTANTIALLY EQUIVALENT	1
HEALTHHUB
	SUBSTANTIALLY EQUIVALENT	1
HEURON CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
HOTH INTELLIGENCE, INC.
	SUBSTANTIALLY EQUIVALENT	1
HURA IMAGING, INC.
	SUBSTANTIALLY EQUIVALENT	1
HYPERFINE RESEARCH, INC.
	SUBSTANTIALLY EQUIVALENT	1
IAID
	SUBSTANTIALLY EQUIVALENT	1
ICAT SOLUTIONS, LTD.
	SUBSTANTIALLY EQUIVALENT	2
IMAGE INSTRUMENTS GMBH
	SUBSTANTIALLY EQUIVALENT	1
IMAGING WAVE, LLC
	SUBSTANTIALLY EQUIVALENT	1
IMMERSIVETOUCH
	SUBSTANTIALLY EQUIVALENT	1
IMMERSIVETOUCH, INC.
	SUBSTANTIALLY EQUIVALENT	1
IN-MED PROGNOSTICS L3C
	SUBSTANTIALLY EQUIVALENT	1
INFOMED SOFTWARE, S.L.
	SUBSTANTIALLY EQUIVALENT	1
INHEART, SAS
	SUBSTANTIALLY EQUIVALENT	1
INTELLIJOINT SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTER MEDICAL MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
INTRADYS
	SUBSTANTIALLY EQUIVALENT	1
INVIVO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INVIZ CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
IONIC HEALTH
	SUBSTANTIALLY EQUIVALENT	1
ISCHEMAVIEW, INC.
	SUBSTANTIALLY EQUIVALENT	3
JAZZ IMAGING
	SUBSTANTIALLY EQUIVALENT	1
JLK, INC.
	SUBSTANTIALLY EQUIVALENT	3
JOINTVUE, LLC
	SUBSTANTIALLY EQUIVALENT	1
KINEPICT HEALTH, LTD.
	SUBSTANTIALLY EQUIVALENT	1
KONICA MINOLTA HEALTHCARE AMERICAS, INC.
	SUBSTANTIALLY EQUIVALENT	1
KONICA MINOLTA, INC.
	SUBSTANTIALLY EQUIVALENT	4
LAZARUS 3D
	SUBSTANTIALLY EQUIVALENT	1
LAZARUS 3D, INC.
	SUBSTANTIALLY EQUIVALENT	1
LEAD TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
LENTO MEDICAL INNOVATION, INC.
	SUBSTANTIALLY EQUIVALENT	1
LEXI CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LG ELECTRONICS.INC
	SUBSTANTIALLY EQUIVALENT	2
LIMBUS AI, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIVE MEDICA, LLC
	SUBSTANTIALLY EQUIVALENT	1
LONGWOOD VALLEY MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
MAIHUB CORP.
	SUBSTANTIALLY EQUIVALENT	1
MATERIALISE N.V
	SUBSTANTIALLY EQUIVALENT	3
MDAI, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	4
MEDAPP S.A.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL TEMPLATES AG
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDIIMG CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEDILAB MANUTENCAO E SITEMAS LTDA
	SUBSTANTIALLY EQUIVALENT	1
MEDIOTT, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDISO MEDICAL IMAGING SYSTEMS, LTTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDIVIEW XR, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDVISO AB
	SUBSTANTIALLY EQUIVALENT	1
MEGAGEN IMPLANT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MERGE HEALTHCARE INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
MICROSTRUCTURE IMAGING, INC.
	SUBSTANTIALLY EQUIVALENT	1
MIGHTY OAK MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MIM SOFTWARE, INC.
	SUBSTANTIALLY EQUIVALENT	6
MINT LABS, INC., D/B/A. QMENTA
	SUBSTANTIALLY EQUIVALENT	1
MIRADA MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
MIRRORME3D, LLC
	SUBSTANTIALLY EQUIVALENT	1
MOTILENT, LTD.
	SUBSTANTIALLY EQUIVALENT	1
MYCARDIUM AI LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MYSEGMENTER TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
NARNAR, LLC
	SUBSTANTIALLY EQUIVALENT	1
NAVBIT PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
NAVIER MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
NAVISWISS AG
	SUBSTANTIALLY EQUIVALENT	1
NESA MEDTECH PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
NEUROPHET., INC.
	SUBSTANTIALLY EQUIVALENT	2
NEUROSPECTRUM INSIGHTS CORP.
	SUBSTANTIALLY EQUIVALENT	1
NEXSYS ELECTRONICS INC. DBA MEDWEB
	SUBSTANTIALLY EQUIVALENT	1
NICO-LAB B.V.
	SUBSTANTIALLY EQUIVALENT	1
NINES, INC.
	SUBSTANTIALLY EQUIVALENT	1
NOBEL BIOCARE AB
	SUBSTANTIALLY EQUIVALENT	2
NORDICNEUROLAB AS
	SUBSTANTIALLY EQUIVALENT	3
OLEA MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
OLEA MEDICAL S.A.S.
	SUBSTANTIALLY EQUIVALENT	3
OMNISCIENT NEUROTECHNOLOGY PTY LTD (O8T)
	SUBSTANTIALLY EQUIVALENT	2
OPENRAD SERVICES UK, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ORCA DENTAL AI , LTD.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX US, LLC
	SUBSTANTIALLY EQUIVALENT	1
ORTHOGRID SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOSOFT D/B/A ZIMMER CAS
	SUBSTANTIALLY EQUIVALENT	2
ORTHOSOFT INC (D/B/A ZIMMER CAS)
	SUBSTANTIALLY EQUIVALENT	2
ORYX DENTAL SOFTWARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
OVERJET, INC.
	SUBSTANTIALLY EQUIVALENT	1
PATTERSON DENTAL SUPPLY, INC.
	SUBSTANTIALLY EQUIVALENT	2
PEEK HEALTH, S.A.
	SUBSTANTIALLY EQUIVALENT	2
PERCEPTION VISION MEDICAL TECHNOLOGIES LTD.CO.
	SUBSTANTIALLY EQUIVALENT	1
PERSPECTUM
	SUBSTANTIALLY EQUIVALENT	2
PERSPECTUM, LTD.
	SUBSTANTIALLY EQUIVALENT	1
PHANTOMICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS DS NORTH AMERICA, LLC
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
	SUBSTANTIALLY EQUIVALENT	5
PHILIPS MEDICAL SYSTEMS TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS ULTRASOUND, INC.
	SUBSTANTIALLY EQUIVALENT	1
PIE MEDICAL IMAGING BV
	SUBSTANTIALLY EQUIVALENT	2
PIXEE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
PIXYL SA
	SUBSTANTIALLY EQUIVALENT	1
PMX, INC.
	SUBSTANTIALLY EQUIVALENT	1
POLAREAN, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRECISIONOS TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRODIGIDENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
PYMEDIX
	SUBSTANTIALLY EQUIVALENT	1
QUANTIB B.V.
	SUBSTANTIALLY EQUIVALENT	3
QUIBIM S.L.
	SUBSTANTIALLY EQUIVALENT	1
RADICAL IMAGING, LLC
	SUBSTANTIALLY EQUIVALENT	1
RADIOBOTICS APS
	SUBSTANTIALLY EQUIVALENT	1
RADISEN CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
RADLINK, INC.
	SUBSTANTIALLY EQUIVALENT	1
RADUNITY CORP.
	SUBSTANTIALLY EQUIVALENT	1
RAMSOFT, INC.
	SUBSTANTIALLY EQUIVALENT	1
RAY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
REAL VIEW IMAGING , LTD.
	SUBSTANTIALLY EQUIVALENT	1
REALIZE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
RICOH USA, INC.
	SUBSTANTIALLY EQUIVALENT	2
ROCLUB GMBH
	SUBSTANTIALLY EQUIVALENT	1
ROLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
S.M.A.I.O
	SUBSTANTIALLY EQUIVALENT	2
SAMSUNG MEDISON CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SEGANA, INC.
	SUBSTANTIALLY EQUIVALENT	1
SENTIAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
SERV MEDICAL PTE., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
SHEN ZHEN CAMBRIDGE-HIT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE GMBH
	SUBSTANTIALLY EQUIVALENT	7
SIEMENS HEALTHINEERS AG
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS MEDICAL SOLUTION USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS MEDICAL SOLUTIONS USA, INC.
	SUBSTANTIALLY EQUIVALENT	5
SIEMENS MEDICAL SOULTIONS USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIGMA SCIENTIFIC SERVICES, LLC
	SUBSTANTIALLY EQUIVALENT	1
SINGULAR HEALTH PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	2
SIRA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIRONA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
SOFTNETA UAB
	SUBSTANTIALLY EQUIVALENT	1
SOTA PRECISION OPTICS, INC. DBA SOTA IMAGING
	SUBSTANTIALLY EQUIVALENT	1
SPECTO MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
SPECTRUM DYNAMICS MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUBTLE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
SURGICAL INFORMATION SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SYNOPSYS (NORTHERN EUROPE) , LTD.
	SUBSTANTIALLY EQUIVALENT	1
SYNTHESIS HEALTH INTELLIGENCE, INC.
	SUBSTANTIALLY EQUIVALENT	1
TAE YOUNG SOFT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TECHFIT DIGITAL SURGERY, INC.
	SUBSTANTIALLY EQUIVALENT	1
TECHHEIM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TERARECON,INC.
	SUBSTANTIALLY EQUIVALENT	1
TRANSLATIONAL MRI, LLC
	SUBSTANTIALLY EQUIVALENT	1
TURING MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
TWINSIGHT
	SUBSTANTIALLY EQUIVALENT	1
UC-CARE , LTD.
	SUBSTANTIALLY EQUIVALENT	1
VIEWORKS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VIRTUAL RADIOLOGIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VISIBLE PATIENT, SAS
	SUBSTANTIALLY EQUIVALENT	1
VISUS HEALTH IT GMBH
	SUBSTANTIALLY EQUIVALENT	2
VOLPARA HEALTH TECHNOLOGIES LIMITED
	SUBSTANTIALLY EQUIVALENT	1
VOXIMETRY, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
VUZE MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	2
XIRONETIC, LLC
	SUBSTANTIALLY EQUIVALENT	1
XORAN TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
YIWEI MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
YUKUN (BEIJING) TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZIRKONZAHN SRL
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	70	70
2022	28	28
2023	26	28
2024	42	42
2025	133	133
2026	28	28

Device Problems	MDRs with this Device Problem	Events in those MDRs
Computer Software Problem	92	92
Application Program Problem: Parameter Calculation Error	35	35
Poor Quality Image	34	34
Application Program Problem	29	29
Improper or Incorrect Procedure or Method	18	19
Loss of Data	16	16
No Apparent Adverse Event	15	15
Adverse Event Without Identified Device or Use Problem	13	13
Use of Incorrect Control/Treatment Settings	11	11
No Display/Image	10	10
Insufficient Information	10	10
Use of Device Problem	9	10
Data Problem	9	9
Incorrect, Inadequate or Imprecise Result or Readings	8	8
Failure to Transmit Record	7	7
Product Quality Problem	6	6
Patient Data Problem	5	5
Application Program Freezes, Becomes Nonfunctional	5	5
Defective Component	5	5
Incorrect Measurement	4	4
Inadequate User Interface	3	3
Installation-Related Problem	3	3
Missing Test Results	3	3
Unexpected Shutdown	3	3
Device Displays Incorrect Message	3	3
Device Dislodged or Dislocated	2	2
Calibration Problem	2	2
Application Program Version or Upgrade Problem	2	2
Inaccurate Information	2	2
Imprecision	2	2
Break	2	2
Connection Problem	1	1
Device Ingredient or Reagent Problem	1	2
Device Markings/Labelling Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Communication or Transmission Problem	1	1
Operating System Becomes Nonfunctional	1	1
Problem with Software Installation	1	1
Reset Problem	1	1
Battery Problem	1	1
Activation Failure	1	1
Wireless Communication Problem	1	1
Unintended Application Program Shut Down	1	1
Missing Information	1	1
Failure to Zero	1	1
High Readings	1	1
Image Orientation Incorrect	1	1
Labelling, Instructions for Use or Training Problem	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	279	279
Insufficient Information	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Breast Mass	11	11
Pneumonia	4	4
Pneumothorax	2	2
Hematoma	2	2
Cardiac Arrest	2	2
Thrombosis/Thrombus	2	2
Unspecified Tissue Injury	2	3
Ruptured Aneurysm	2	2
Unspecified Heart Problem	2	2
Hemorrhage/Bleeding	2	2
Bacterial Infection	2	4
Unintended Radiation Exposure	2	2
Fatigue	1	1
Gastrointestinal Hemorrhage	1	1
Brain Injury	1	1
Hemoptysis	1	1
Cyst(s)	1	2
Ischemic Heart Disease	1	1
Blister	1	1
Foreign Body In Patient	1	2
Burning Sensation	1	1
Pleural Effusion	1	1
Viral Infection	1	1
Chest Pain	1	1
Erythema	1	1
Pain	1	1
Dyspnea	1	1
Scar Tissue	1	1
Cough	1	1
Endocarditis	1	1
Myocardial Infarction	1	1
No Consequences Or Impact To Patient	1	1
Cancer	1	1
Tissue Breakdown	1	1
Ambulation Difficulties	1	2
Device Embedded In Tissue or Plaque	1	2
Unspecified Reproductive System or Breast Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Agfa Healthcare NV	II	Oct-10-2024
2	Agfa Healthcare NV	II	Jan-20-2023
3	Brainlab AG	II	Mar-18-2025
4	Brainreader ApS	II	Jan-29-2021
5	CHANGE HEALTHCARE CANADA COMPANY	II	Oct-02-2025
6	CHANGE HEALTHCARE CANADA COMPANY	II	Dec-14-2023
7	CHANGE HEALTHCARE CANADA COMPANY	II	Nov-06-2023
8	CHANGE HEALTHCARE CANADA COMPANY	II	Jun-02-2021
9	CHANGE HEALTHCARE CANADA COMPANY	II	Apr-28-2021
10	DICOM Grid, Inc.	II	Dec-18-2025
11	DICOM Grid, Inc. d/b/a Ambra Health	II	Sep-27-2022
12	Digisonics, Inc	II	Jul-20-2023
13	Echopixel, Inc.	II	May-21-2025
14	Echopixel, Inc.	II	May-16-2025
15	Exocad GmbH	II	Sep-25-2023
16	FUJIFILM Healthcare Americas Corporation	II	Mar-20-2025
17	FUJIFILM Healthcare Americas Corporation	II	Mar-07-2024
18	FUJIFILM Healthcare Americas Corporation	II	Feb-21-2024
19	Focalyx Technologies, LLC.	II	Feb-03-2026
20	Fujifilm Medical Systems U.S.A., Inc.	II	Jun-02-2021
21	Fujifilm Medical Systems U.S.A., Inc.	II	Apr-02-2021
22	Fujifilm Medical Systems U.S.A., Inc.	II	Jan-22-2021
23	Fujifilm Medical Systems U.S.A., Inc.	II	Jan-17-2021
24	GE Healthcare	II	Mar-28-2025
25	GE Healthcare	II	Nov-07-2024
26	GE Healthcare	II	Oct-09-2024
27	GE Healthcare	II	Sep-24-2024
28	GE Healthcare	II	Sep-17-2024
29	GE Healthcare	II	Oct-23-2023
30	GE Healthcare	II	Oct-20-2023
31	GE Healthcare	II	May-02-2023
32	GE Healthcare GmbH	II	Dec-16-2025
33	GE Healthcare GmbH	II	Sep-13-2024
34	GE Healthcare, LLC	II	Aug-24-2022
35	GE Healthcare, LLC	II	Jul-25-2022
36	GE Healthcare, LLC	II	Jul-05-2022
37	GE Healthcare, LLC	II	Jun-03-2022
38	GE Healthcare, LLC	II	Dec-02-2021
39	GE Healthcare, LLC	II	Oct-02-2021
40	GE Healthcare, LLC	II	Sep-22-2021
41	GE Healthcare, LLC	II	May-05-2021
42	GE Medical Systems, LLC	II	Dec-16-2022
43	GE Medical Systems, SCS	II	Oct-08-2025
44	INTELERAD MEDICAL SYSTEMS INCORPORATED	II	Nov-26-2025
45	INTELERAD MEDICAL SYSTEMS INCORPORATED	II	Feb-21-2025
46	Konica Minolta Healthcare Americas, Inc.	II	Jan-14-2022
47	MIM Software Inc	II	Mar-04-2025
48	Medicrea International	II	Feb-07-2025
49	Merge Healthcare, Inc.	II	Mar-20-2025
50	Mint Medical GmbH	II	Dec-20-2024
51	NordicNeuroLab AS	II	Jul-25-2022
52	OLEA MEDICAL	II	Oct-18-2023
53	PIE Medical Imaging B.V.	II	Aug-12-2025
54	Philips Medical Systems Nederland B.V.	II	Sep-09-2025
55	Philips Medical Systems Nederland B.V.	II	May-08-2025
56	Philips Medical Systems Nederland B.V.	II	Feb-28-2025
57	Philips Medical Systems Technologies Ltd.	II	Nov-20-2024
58	Philips North America, LLC	II	Jan-13-2021
59	Philips North America Llc	II	Apr-06-2022
60	Simpleware Product Group, SYNOPSYS NORTHERN EUROPE	II	Aug-12-2021
61	Surgical Theater Inc	II	Oct-24-2025
62	Virtual Radiologic Corp.	II	Jul-21-2023