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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
ACO HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ALPINION MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 9
ATYS
  SUBSTANTIALLY EQUIVALENT 1
BEIJING KONTED MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING KONTED MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
BIONET CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BK MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 3
BUTTERFLY NETWORK, INC.
  SUBSTANTIALLY EQUIVALENT 2
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 11
CHISON MEDICAL TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
CLARIUS MOBILE HEALTH CORP.
  SUBSTANTIALLY EQUIVALENT 4
COMPAL ELECTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CRYSTALLINE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOLY
  SUBSTANTIALLY EQUIVALENT 1
E-SCOPICS
  SUBSTANTIALLY EQUIVALENT 2
ECHONOUS, INC.
  SUBSTANTIALLY EQUIVALENT 3
EDAN INSTRUMENTS, INC
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDGELIFE TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
ESAOTE S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
ESAOTE, S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
EXACT IMAGING INC.
  SUBSTANTIALLY EQUIVALENT 1
EXACT IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXO IMAGING INC.
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM SONOSITE INC.
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM SONOSITE, INC.
  SUBSTANTIALLY EQUIVALENT 4
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 6
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 1
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 DIAGNOSTIC,
  SUBSTANTIALLY EQUIVALENT 2
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 17
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS,
  SUBSTANTIALLY EQUIVALENT 15
GUANGDONG YOUKEY MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
IMACOR INC
  SUBSTANTIALLY EQUIVALENT 1
IMSONIC MEDICAL CHINA, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERSON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KOLO MEDICAL (SUZHOU) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LELTEK INC
  SUBSTANTIALLY EQUIVALENT 3
LELTEK INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISONO
  SUBSTANTIALLY EQUIVALENT 1
NAVIGANT CONSULTING - ON BEHALF OF ESAOTE S.P.A.
  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 2
PHILIPS ULTRASOUND LLC
  SUBSTANTIALLY EQUIVALENT 7
PHILIPS ULTRASOUND, INC.
  SUBSTANTIALLY EQUIVALENT 4
QINGDAO HISENSE MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
QISDA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG MEDISON CO., LTD
  SUBSTANTIALLY EQUIVALENT 5
SAMSUNG MEDISON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 27
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 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 17
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 11
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 5
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 8
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 9
SIEMENS MEDICAL SOLUTIONS, USA, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS, USA, INC.
  SUBSTANTIALLY EQUIVALENT 4
SONIO
  SUBSTANTIALLY EQUIVALENT 2
SONOSCANNER
  SUBSTANTIALLY EQUIVALENT 1
SONOSCANNER SARL
  SUBSTANTIALLY EQUIVALENT 1
SONOSCAPE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 5
SUPERSONIC IMAGINE
  SUBSTANTIALLY EQUIVALENT 5
SYNOVIS MICRO COMPANIES ALLIANCE
  SUBSTANTIALLY EQUIVALENT 1
TELEFIELD MEDICAL IMAGING (SHENZHEN) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TELEMED
  SUBSTANTIALLY EQUIVALENT 1
TERATECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TISSUE DIFFERENTIATION INTELLIGENCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
VAVE HEALTH, INC
  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
2019 59 59
2020 67 67
2021 213 213
2022 186 186
2023 229 229
2024 225 225

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 333 333
Adverse Event Without Identified Device or Use Problem 65 65
Application Program Freezes, Becomes Nonfunctional 59 59
Patient Data Problem 59 59
Mechanical Jam 50 50
No Display/Image 44 44
Detachment of Device or Device Component 31 31
Poor Quality Image 30 30
Unexpected Shutdown 24 24
Unintended Application Program Shut Down 23 23
No Device Output 18 18
Loss of Data 16 16
Fire 16 16
Use of Device Problem 16 16
Operating System Becomes Nonfunctional 14 14
Failure to Power Up 13 13
Output Problem 12 12
Data Problem 12 12
Incorrect Measurement 11 11
Display or Visual Feedback Problem 10 10
Smoking 10 10
Image Display Error/Artifact 8 8
Flare or Flash 8 8
Battery Problem 8 8
Device Dislodged or Dislocated 7 7
Arcing 6 6
No Visual Prompts/Feedback 6 6
Computer Operating System Problem 6 6
Visual Prompts will not Clear 6 6
Insufficient Information 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Computer Software Problem 5 5
Sharp Edges 5 5
Therapeutic or Diagnostic Output Failure 5 5
Unintended Electrical Shock 5 5
Electrical Overstress 4 4
Defective Component 4 4
Inadequate User Interface 4 4
Sparking 4 4
Display Difficult to Read 4 4
Overheating of Device 4 4
Material Separation 4 4
Mechanical Problem 4 4
Power Problem 4 4
Communication or Transmission Problem 4 4
Temperature Problem 3 3
Material Split, Cut or Torn 3 3
Improper or Incorrect Procedure or Method 3 3
No Apparent Adverse Event 3 3
Erratic or Intermittent Display 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 723 723
No Consequences Or Impact To Patient 69 69
No Known Impact Or Consequence To Patient 68 68
Perforation 51 51
Insufficient Information 35 35
Hemorrhage/Bleeding 12 12
Laceration(s) 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Cardiac Arrest 5 5
Death 4 4
No Code Available 4 4
Injury 4 4
No Patient Involvement 4 4
Pneumothorax 3 3
Gastroesophageal Burn 3 3
Perforation of Esophagus 3 3
Laceration(s) of Esophagus 3 3
Perforation of Vessels 3 3
Pneumonia 3 3
High Blood Pressure/ Hypertension 2 2
Superficial (First Degree) Burn 2 2
Bruise/Contusion 2 2
Respiratory Failure 2 2
Sepsis 2 2
Not Applicable 2 2
Necrosis 2 2
No Information 2 2
Hemoptysis 2 2
Cardiovascular Insufficiency 2 2
Pain 2 2
Hyperextension 2 2
Congenital Defect/Deformity 2 2
Loss of consciousness 1 1
Unspecified Heart Problem 1 1
Hypoxia 1 1
Unspecified Tissue Injury 1 1
Stenosis 1 1
Tachycardia 1 1
Limb Fracture 1 1
Missing Value Reason 1 1
Unspecified Hepatic or Biliary Problem 1 1
Numbness 1 1
Thrombosis 1 1
Septic Shock 1 1
Erythema 1 1
Cardiac Tamponade 1 1
Rupture 1 1
Muscle Weakness 1 1
Hematoma 1 1
Unspecified Musculoskeletal problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B-K Medical A/S II Oct-18-2024
2 B-K Medical A/S II Jan-25-2024
3 Butterfly Network, Inc. II Mar-17-2020
4 Butterfly Network, Inc. II Mar-17-2020
5 Canon Medical System, USA, INC. II Nov-08-2022
6 ESAOTE S.P.A II Sep-30-2020
7 Echonous Inc II Jul-10-2024
8 FUJIFILM Healthcare Americas Corporation II May-22-2024
9 FujiFilm Healthcare Americas Corporation II Nov-02-2021
10 FujiFilm Healthcare Americas Corporation II Nov-02-2021
11 GE HEALTHCARE AUSTRIA GMBH & CO II Jan-30-2024
12 GE Healthcare, LLC II Jul-12-2019
13 GE Healthcare, LLC II Jun-18-2019
14 GE Healthcare, LLC II Jan-30-2019
15 GE MEDICAL SYSTEMS, ISRAEL LTD. II Sep-29-2023
16 GE Medical Systems, LLC II Dec-22-2022
17 GE Vingmed Ultrasound As II Jul-05-2024
18 GE Vingmed Ultrasound As II Jul-10-2023
19 Hitachi Healthcare Americas Corporation II Aug-16-2021
20 Hitachi Medical Systems America Inc II Mar-19-2021
21 Mindray DS USA, Inc. dba Mindray North America II Feb-05-2020
22 NeuroLogica Corporation II Aug-14-2019
23 NovaSignal Corp. II Jun-27-2024
24 NovaSignal Corp. II Feb-01-2023
25 Olympus Corporation of the Americas II Nov-27-2020
26 Olympus Corporation of the Americas II Mar-12-2019
27 Philips Ultrasound Inc II Oct-16-2021
28 Philips Ultrasound Inc II Oct-07-2021
29 Philips Ultrasound Inc II Aug-16-2021
30 Philips Ultrasound Inc II Feb-03-2021
31 Philips Ultrasound Inc II Feb-02-2021
32 Philips Ultrasound Inc II Jan-14-2021
33 Philips Ultrasound Inc II Aug-06-2019
34 Philips Ultrasound, Inc. II May-03-2024
35 Philips Ultrasound, Inc. II Nov-09-2023
36 Siemens Medical Solutions USA, Inc. II Sep-24-2024
37 Siemens Medical Solutions USA, Inc. II Apr-19-2024
38 Siemens Medical Solutions USA, Inc. II Sep-13-2023
39 Siemens Medical Solutions USA, Inc. II Apr-27-2022
40 Siemens Medical Solutions USA, Inc. II Mar-11-2022
41 Siemens Medical Solutions USA, Inc. II Feb-03-2022
42 Siemens Medical Solutions USA, Inc. II Sep-14-2021
43 Siemens Medical Solutions USA, Inc. II Apr-01-2021
44 Siemens Medical Solutions USA, Inc. II Aug-22-2019
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