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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
Regulation Description Ultrasonic pulsed doppler imaging system.
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 8
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 10
CARBON (SHENZHEN) MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHISON MEDICAL TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
CLARIUS MOBILE HEALTH CORP.
  SUBSTANTIALLY EQUIVALENT 3
COMPAL ELECTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTEC MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CRYSTALLINE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DEEPECHO
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOLY
  SUBSTANTIALLY EQUIVALENT 1
E-SCOPICS
  SUBSTANTIALLY EQUIVALENT 2
ECHONOUS, INC.
  SUBSTANTIALLY EQUIVALENT 4
EDAN INSTRUMENTS INC.
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDGELIFE TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
ESAOTE S.P.A.
  SUBSTANTIALLY EQUIVALENT 4
ESONIC TECHNOLOGY (WUHAN) CO., LTD
  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 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 5
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 19
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 1
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 2
MEDISONO
  SUBSTANTIALLY EQUIVALENT 1
NOVASIGNAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NURODATA INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS ULTRASOUND
  SUBSTANTIALLY EQUIVALENT 4
PHILIPS ULTRASOUND LLC
  SUBSTANTIALLY EQUIVALENT 13
PHILIPS ULTRASOUND, INC.
  SUBSTANTIALLY EQUIVALENT 4
QINGDAO HISENSE MEDICAL EQUIPMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
SAMSUNG MEDISON CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
SAMSUNG MEDISON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 21
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. (SIUI)
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN DELICA MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 11
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 13
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 MEDICAL SOLUTIONS USA, INC
  SUBSTANTIALLY EQUIVALENT 8
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 8
SIEMENS MEDICAL SOLUTIONS, USA, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS, USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
SONIO
  SUBSTANTIALLY EQUIVALENT 2
SONOSCANNER
  SUBSTANTIALLY EQUIVALENT 1
SONOSCANNER SARL
  SUBSTANTIALLY EQUIVALENT 1
SONOSCAPE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 5
SUPERSONIC IMAGINE
  SUBSTANTIALLY EQUIVALENT 4
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 1
VINNO TECHNOLOGY (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
VINNO TECHNOLOGY (SUZHOU) CO.,LTD
  SUBSTANTIALLY EQUIVALENT 3
VINNO TECHNOLOGY (SUZHOU) CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 67 67
2021 213 213
2022 186 186
2023 229 229
2024 266 266
2025 329 329

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 398 398
Application Program Freezes, Becomes Nonfunctional 89 89
Adverse Event Without Identified Device or Use Problem 72 72
Mechanical Jam 62 62
Material Integrity Problem 51 51
Poor Quality Image 46 46
No Display/Image 44 44
Patient Data Problem 42 42
Detachment of Device or Device Component 33 33
Unintended Application Program Shut Down 31 31
Unexpected Shutdown 30 30
Material Split, Cut or Torn 21 21
Fire 21 21
No Device Output 20 20
Material Separation 18 18
Failure to Power Up 18 18
Loss of Data 17 17
No Apparent Adverse Event 15 15
Break 15 15
Operating System Becomes Nonfunctional 14 14
Use of Device Problem 14 14
Computer Software Problem 13 13
Incorrect Measurement 12 12
Output Problem 11 11
Crack 10 10
Image Display Error/Artifact 10 10
Display or Visual Feedback Problem 10 10
Smoking 10 10
Unintended Electrical Shock 9 9
Insufficient Information 9 9
Sharp Edges 7 7
Device Dislodged or Dislocated 7 7
Flare or Flash 7 7
Battery Problem 7 7
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Visual Prompts will not Clear 6 6
No Visual Prompts/Feedback 6 6
Arcing 6 6
Data Problem 6 6
Overheating of Device 5 5
Material Fragmentation 5 5
Peeled/Delaminated 5 5
Power Problem 5 5
Electrical Overstress 4 4
Therapeutic or Diagnostic Output Failure 4 4
Application Program Problem 4 4
Display Difficult to Read 4 4
Communication or Transmission Problem 4 4
Erratic or Intermittent Display 4 4
Inadequate User Interface 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1054 1054
No Consequences Or Impact To Patient 59 59
Perforation 57 57
Insufficient Information 46 46
No Known Impact Or Consequence To Patient 32 32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Laceration(s) 11 11
Hemorrhage/Bleeding 9 9
Cardiac Arrest 7 7
Pneumothorax 3 3
Gastroesophageal Burn 3 3
Shock 3 3
Perforation of Vessels 3 3
Injury 3 3
Pneumonia 3 3
Pain 3 3
Superficial (First Degree) Burn 2 2
High Blood Pressure/ Hypertension 2 2
Bruise/Contusion 2 2
Death 2 2
Respiratory Failure 2 2
Skin Tears 2 2
Sepsis 2 2
Cardiovascular Insufficiency 2 2
Necrosis 2 2
Perforation of Esophagus 2 2
Hemoptysis 2 2
Laceration(s) of Esophagus 2 2
No Patient Involvement 2 2
Congenital Defect/Deformity 2 2
Hyperextension 2 2
Loss of consciousness 1 1
Hypoxia 1 1
Unspecified Heart Problem 1 1
Stenosis 1 1
Tachycardia 1 1
Unspecified Tissue Injury 1 1
Limb Fracture 1 1
Missing Value Reason 1 1
Unspecified Hepatic or Biliary Problem 1 1
Numbness 1 1
Septic Shock 1 1
Thrombosis 1 1
Oversedation 1 1
Cardiac Tamponade 1 1
Rupture 1 1
Hematoma 1 1
Muscle Weakness 1 1
Presyncope 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 MEDICAL SYSTEMS, ISRAEL LTD. II Sep-29-2023
13 GE Medical Systems China Co., Ltd. II Jun-26-2025
14 GE Medical Systems, LLC II Apr-11-2025
15 GE Medical Systems, LLC II Dec-22-2022
16 GE Vingmed Ultrasound As II Jul-05-2024
17 GE Vingmed Ultrasound As II Jul-10-2023
18 Hitachi Healthcare Americas Corporation II Aug-16-2021
19 Hitachi Medical Systems America Inc II Mar-19-2021
20 Mindray DS USA, Inc. dba Mindray North America II Feb-05-2020
21 NovaSignal Corp. II Jun-27-2024
22 NovaSignal Corp. II Feb-01-2023
23 Olympus Corporation of the Americas II Nov-27-2020
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 May-03-2024
31 Philips Ultrasound, Inc. II Nov-09-2023
32 Siemens Medical Solutions USA, Inc. II Sep-24-2024
33 Siemens Medical Solutions USA, Inc. II Apr-19-2024
34 Siemens Medical Solutions USA, Inc. II Sep-13-2023
35 Siemens Medical Solutions USA, Inc. II Apr-27-2022
36 Siemens Medical Solutions USA, Inc. II Mar-11-2022
37 Siemens Medical Solutions USA, Inc. II Feb-03-2022
38 Siemens Medical Solutions USA, Inc. II Sep-14-2021
39 Siemens Medical Solutions USA, Inc. II Apr-01-2021
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