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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, imaging, pulsed doppler, ultrasonic
Product CodeIYN
Regulation Number 892.1550
Device Class 2


Premarket Reviews
ManufacturerDecision
ACO HEALTHCARE CO,. LTD.
  SUBSTANTIALLY EQUIVALENT 1
ALPINION MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 12
ATYS
  SUBSTANTIALLY EQUIVALENT 1
BIONET CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BK MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 4
BUTTERFLY NETWORK, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 11
CHISON MEDICAL TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
CLARIUS MOBILE HEALTH CORP.
  SUBSTANTIALLY EQUIVALENT 3
COMPAL ELECTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CRYSTALLINE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
E-SCOPICS
  SUBSTANTIALLY EQUIVALENT 1
ECHONOUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EDAN INSTRUMENTS, INC
  SUBSTANTIALLY EQUIVALENT 2
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ESAOTE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
ESAOTE S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
ESAOTE, S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
EXACT IMAGING INC.
  SUBSTANTIALLY EQUIVALENT 1
EXACT IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXO IMAGING INC.
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM SONOSITE INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM SONOSITE, INC.
  SUBSTANTIALLY EQUIVALENT 5
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 10
GE MEDICAL SYSTEM ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC
  SUBSTANTIALLY EQUIVALENT 2
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS,LLC
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS ULTRASOUND AND
  SUBSTANTIALLY EQUIVALENT 4
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 13
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS,
  SUBSTANTIALLY EQUIVALENT 16
GUANGDONG YOUKEY MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU SONOSTAR TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEALCERION CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HEALCERION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI HEALTHCARE AMERICAS
  SUBSTANTIALLY EQUIVALENT 4
HITACHI HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
IMACOR INC
  SUBSTANTIALLY EQUIVALENT 1
IMSONIC MEDICAL CHINA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KOLO MEDICAL (SUZHOU) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LELTEK INC
  SUBSTANTIALLY EQUIVALENT 3
NATIONAL TAIWAN UNIVERSITY
  SUBSTANTIALLY EQUIVALENT 1
NAVIGANT CONSULTING - ON BEHALF OF ESAOTE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
NEURAL ANALYTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVASIGNAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS ULTRASOUND
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS ULTRASOUND LLC
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS ULTRASOUND, INC.
  SUBSTANTIALLY EQUIVALENT 7
QINGDAO HISENSE MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
QISDA CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SAMSUNG MEDISON CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG MEDISON CO., LTD
  SUBSTANTIALLY EQUIVALENT 6
SAMSUNG MEDISON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 25
SENO MEDICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. (SIUI)
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN DELICA MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 21
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 5
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN WELL.D MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO.LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHINEERS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC
  SUBSTANTIALLY EQUIVALENT 9
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 8
SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GROUP
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS, USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
SONIO
  SUBSTANTIALLY EQUIVALENT 1
SONOSCANNER
  SUBSTANTIALLY EQUIVALENT 1
SONOSCAPE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 5
SUPERSONIC IMAGINE
  SUBSTANTIALLY EQUIVALENT 6
TELEMED
  SUBSTANTIALLY EQUIVALENT 1
TERATECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TISSUE DIFFERENTIATION INTELLIGENCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
VENTRIPOINT DIAGNOSTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIASONIX LTD.
  SUBSTANTIALLY EQUIVALENT 2
VINNO TECHNOLOGY (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
VINNO TECHNOLOGY (SUZHOU) CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
VINNO TECHNOLOGY (SUZHOU) CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUHAN ZONCARE BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 82 82
2019 59 59
2020 67 67
2021 213 213
2022 186 186
2023 155 155

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 227 227
Patient Data Problem 55 55
No Display/Image 52 52
Adverse Event Without Identified Device or Use Problem 50 50
Mechanical Jam 37 37
Detachment of Device or Device Component 27 27
Poor Quality Image 20 20
Application Program Freezes, Becomes Nonfunctional 20 20
Unexpected Shutdown 19 19
Loss of Data 15 15
Device Operational Issue 15 15
Use of Device Problem 15 15
No Device Output 14 14
Fire 13 13
Operating System Becomes Nonfunctional 13 13
Output Problem 12 12
Display or Visual Feedback Problem 12 12
Unintended Application Program Shut Down 11 11
Incorrect Measurement 9 9
Smoking 9 9
Image Display Error/Artifact 8 8
Computer Software Problem 8 8
Data Problem 8 8
Failure to Power Up 7 7
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Device Dislodged or Dislocated 7 7
Battery Problem 7 7
Computer Operating System Problem 7 7
Visual Prompts will not Clear 6 6
Arcing 6 6
Device Displays Incorrect Message 6 6
No Visual Prompts/Feedback 6 6
Temperature Problem 6 6
Power Problem 6 6
Therapeutic or Diagnostic Output Failure 5 5
Insufficient Information 4 4
Material Split, Cut or Torn 4 4
Sharp Edges 4 4
Sparking 4 4
Loss of Power 4 4
Electrical Overstress 4 4
Inadequate User Interface 4 4
Overheating of Device 4 4
Mechanical Problem 4 4
Erratic or Intermittent Display 4 4
Display Difficult to Read 3 3
Thermal Decomposition of Device 3 3
Device Emits Odor 3 3
Flare or Flash 3 3
Improper or Incorrect Procedure or Method 3 3
Defective Component 3 3
Intermittent Loss of Power 3 3
Appropriate Term/Code Not Available 3 3
Physical Resistance/Sticking 2 2
Activation Failure 2 2
Noise, Audible 2 2
Unintended Movement 2 2
Unintended Electrical Shock 2 2
Device Fell 2 2
Complete Loss of Power 2 2
Failure to Advance 2 2
Application Program Problem 2 2
Improper Device Output 2 2
Image Orientation Incorrect 2 2
Loose or Intermittent Connection 2 2
Failure to Run on Battery 2 2
Break 2 2
Circuit Failure 2 2
Use of Incorrect Control/Treatment Settings 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Burst Container or Vessel 1 1
No Audible Alarm 1 1
Loss of or Failure to Bond 1 1
Material Frayed 1 1
Electromagnetic Interference 1 1
Electrical /Electronic Property Problem 1 1
False Negative Result 1 1
Material Puncture/Hole 1 1
Failure to Transmit Record 1 1
Peeled/Delaminated 1 1
Output above Specifications 1 1
Difficult to Insert 1 1
Leak/Splash 1 1
Melted 1 1
Electrical Shorting 1 1
Fail-Safe Problem 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Connection Problem 1 1
Charging Problem 1 1
Communication or Transmission Problem 1 1
Defective Device 1 1
Device Tipped Over 1 1
Fumes or Vapors 1 1
Difficult or Delayed Activation 1 1
Device Issue 1 1
Failure to Calibrate 1 1
Structural Problem 1 1
Failure to Align 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 468 468
No Consequences Or Impact To Patient 103 103
No Known Impact Or Consequence To Patient 89 89
Perforation 33 33
Insufficient Information 29 29
No Information 11 11
Hemorrhage/Bleeding 11 11
No Patient Involvement 9 9
No Code Available 8 8
Death 5 5
Laceration(s) 4 4
Injury 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Pain 3 3
Not Applicable 3 3
Perforation of Vessels 3 3
Pneumonia 3 3
Pneumothorax 3 3
Sepsis 2 2
Misdiagnosis 2 2
Laceration(s) of Esophagus 2 2
Perforation of Esophagus 2 2
Hemoptysis 2 2
Necrosis 2 2
Bruise/Contusion 2 2
Breast Cancer 2 2
Cardiac Arrest 2 2
Congenital Defect/Deformity 2 2
Superficial (First Degree) Burn 2 2
Respiratory Failure 2 2
Gastroesophageal Burn 2 2
Hyperextension 2 2
Unspecified Musculoskeletal problem 1 1
Unspecified Tissue Injury 1 1
Pancreatitis 1 1
Unspecified Hepatic or Biliary Problem 1 1
Limb Fracture 1 1
Missing Value Reason 1 1
Constipation 1 1
Unspecified Heart Problem 1 1
Abdominal Distention 1 1
Rupture 1 1
Cardiac Tamponade 1 1
Erythema 1 1
Flatus 1 1
Hematoma 1 1
Mitral Insufficiency 1 1
Muscle Weakness 1 1
High Blood Pressure/ Hypertension 1 1
Hypoxia 1 1
Insufficiency, Valvular 1 1
Loss of consciousness 1 1
Tingling 1 1
Burning Sensation 1 1
Septic Shock 1 1
Thrombosis 1 1
Thrombus 1 1
Respiratory Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Butterfly Network, Inc. II Mar-17-2020
2 Butterfly Network, Inc. II Mar-17-2020
3 Canon Medical System, USA, INC. II Nov-08-2022
4 ESAOTE S.P.A II Sep-30-2020
5 ESAOTE S.P.A. II Oct-23-2018
6 ESAOTE S.P.A. II Mar-20-2018
7 FujiFilm Healthcare Americas Corporation II Nov-02-2021
8 FujiFilm Healthcare Americas Corporation II Nov-02-2021
9 GE Healthcare, LLC II Jul-12-2019
10 GE Healthcare, LLC II Jun-18-2019
11 GE Healthcare, LLC II Jan-30-2019
12 GE Healthcare, LLC II Dec-07-2018
13 GE Medical Systems Ultrasound & Primary Care Diagnostics, LL II Sep-06-2018
14 GE Medical Systems, LLC II Dec-22-2022
15 GE Vingmed Ultrasound As II Jul-10-2023
16 Hitachi Healthcare Americas Corporation II Aug-16-2021
17 Hitachi Medical Systems America Inc II Mar-19-2021
18 Konica Minolta Medical Imaging USA, Inc. II Mar-27-2018
19 Mindray DS USA, Inc. dba Mindray North America II Feb-05-2020
20 NeuroLogica Corporation II Aug-14-2019
21 NovaSignal Corp. II Feb-01-2023
22 Olympus Corporation of the Americas II Nov-27-2020
23 Olympus Corporation of the Americas II Mar-12-2019
24 Philips Ultrasound Inc II Oct-16-2021
25 Philips Ultrasound Inc II Oct-07-2021
26 Philips Ultrasound Inc II Aug-16-2021
27 Philips Ultrasound Inc II Feb-03-2021
28 Philips Ultrasound Inc II Feb-02-2021
29 Philips Ultrasound Inc II Jan-14-2021
30 Philips Ultrasound Inc II Aug-06-2019
31 Siemens Medical Solutions USA, Inc. II Sep-13-2023
32 Siemens Medical Solutions USA, Inc. II Apr-27-2022
33 Siemens Medical Solutions USA, Inc. II Mar-11-2022
34 Siemens Medical Solutions USA, Inc. II Feb-03-2022
35 Siemens Medical Solutions USA, Inc. II Sep-14-2021
36 Siemens Medical Solutions USA, Inc. II Apr-01-2021
37 Siemens Medical Solutions USA, Inc. II Aug-22-2019
38 Siemens Medical Solutions USA, Inc. II Mar-26-2018
39 Siemens Medical Solutions USA, Inc. II Mar-15-2018
40 Toshiba American Medical Systems Inc II Jun-29-2018
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