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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 2
ALPINION MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
ASUSTEK COMPUTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING KONTED MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
BIONET CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOTICSAI, INC.
  SUBSTANTIALLY EQUIVALENT 1
BK MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 3
BUTTERFLY NETWORK, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
CARBON (SHENZHEN) MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHISON MEDICAL TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
CLARIUS MOBILE HEALTH CORP.
  SUBSTANTIALLY EQUIVALENT 3
CONTEC MEDICAL SYSTEMS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
CRYSTALLINE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DEEPECHO
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOLY
  SUBSTANTIALLY EQUIVALENT 2
E-SCOPICS
  SUBSTANTIALLY EQUIVALENT 2
ECHONOUS, INC.
  SUBSTANTIALLY EQUIVALENT 3
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
EDGELIFE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ESAOTE, S.P.A.
  SUBSTANTIALLY EQUIVALENT 5
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 5
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 4
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 AND
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTIC,
  SUBSTANTIALLY EQUIVALENT 2
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 33
GUANGDONG YOUKEY MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GUANGZHOU SONOSTAR TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEALCERION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 4
MEDISONO
  SUBSTANTIALLY EQUIVALENT 1
NOVASIGNAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NURODATA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS ULTRASOUND
  SUBSTANTIALLY EQUIVALENT 4
PHILIPS ULTRASOUND, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS ULTRASOUND, LLC
  SUBSTANTIALLY EQUIVALENT 17
QINGDAO HISENSE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SAMSUNG MEDISON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 23
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 28
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 16
SONIO
  SUBSTANTIALLY EQUIVALENT 2
SONOSCANNER SARL
  SUBSTANTIALLY EQUIVALENT 1
SONOSCAPE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 5
SUPERSONIC IMAGINE
  SUBSTANTIALLY EQUIVALENT 3
SYNOVIS MICRO COMPANIES ALLIANCE
  SUBSTANTIALLY EQUIVALENT 1
TELEFIELD MEDICAL IMAGING (SHENZHEN) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TELEMED
  SUBSTANTIALLY EQUIVALENT 1
VAVE HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIASONIX , LTD.
  SUBSTANTIALLY EQUIVALENT 1
VINNO TECHNOLOGY (SUZHOU) CO.,LTD
  SUBSTANTIALLY EQUIVALENT 5
WUXI HISKY MEDICAL TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 213 214
2022 186 186
2023 229 229
2024 266 266
2025 621 621
2026 84 84

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 430 430
Application Program Freezes, Becomes Nonfunctional 121 121
Material Integrity Problem 115 115
Adverse Event Without Identified Device or Use Problem 83 83
Mechanical Jam 70 71
Poor Quality Image 56 56
Unintended Application Program Shut Down 47 47
Electrical /Electronic Property Problem 46 46
No Display/Image 45 45
Material Split, Cut or Torn 37 37
Detachment of Device or Device Component 36 36
Unexpected Shutdown 34 34
Material Separation 33 33
Patient Data Problem 33 33
Break 26 26
No Device Output 25 25
Fire 25 25
Loss of Data 20 20
Crack 19 19
Fracture 18 18
Failure to Power Up 17 17
No Apparent Adverse Event 16 16
Unintended Electrical Shock 14 14
Insufficient Information 14 14
Operating System Becomes Nonfunctional 13 13
Display or Visual Feedback Problem 12 12
Computer Software Problem 12 12
Use of Device Problem 12 12
Material Puncture/Hole 11 11
Incorrect Measurement 11 11
Image Display Error/Artifact 10 10
Output Problem 10 10
Application Program Problem 8 8
Appropriate Term/Code Not Available 7 7
Smoking 7 7
Flare or Flash 7 7
Sharp Edges 7 7
No Visual Prompts/Feedback 6 6
Erratic or Intermittent Display 6 6
Visual Prompts will not Clear 6 6
Peeled/Delaminated 5 5
Power Problem 5 5
Overheating of Device 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Material Fragmentation 5 5
Battery Problem 5 5
Arcing 5 5
Display Difficult to Read 4 4
Incomplete or Inadequate Connection 4 4
Image Orientation Incorrect 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1372 1373
Perforation 64 64
Insufficient Information 62 62
No Consequences Or Impact To Patient 42 43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Laceration(s) 12 12
Hemorrhage/Bleeding 8 8
Cardiac Arrest 7 7
Perforation of Esophagus 6 6
Shock 4 4
Sepsis 4 4
High Blood Pressure/ Hypertension 3 3
Pneumothorax 3 3
Gastroesophageal Burn 3 3
Pneumonia 3 3
Pain 3 3
Respiratory Failure 2 2
Skin Tears 2 2
Cardiovascular Insufficiency 2 2
Pulmonary Edema 2 2
Perforation of Vessels 2 2
Unspecified Tissue Injury 2 2
Congenital Defect/Deformity 2 2
Dyspnea 2 2
Laceration(s) of Esophagus 2 2
Hemoptysis 2 2
Bowel Perforation 2 2
Necrosis 2 2
Superficial (First Degree) Burn 2 2
Rupture 1 1
Cardiac Tamponade 1 1
Skin Discoloration 1 1
Oversedation 1 1
Septic Shock 1 1
Numbness 1 1
Discomfort 1 1
Vomiting 1 1
Hematoma 1 1
Hyperextension 1 1
Unspecified Hepatic or Biliary Problem 1 1
Presyncope 1 1
Unspecified Musculoskeletal problem 1 1
Limb Fracture 1 1
Muscle/Tendon Damage 1 1
Fetal Distress 1 1
Tachycardia 1 1
Stenosis 1 1
Intraoperative Pain 1 1
Dysphagia/ Odynophagia 1 1
Electric Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B-K Medical A/S II Nov-06-2025
2 B-K Medical A/S II Oct-18-2024
3 B-K Medical A/S II Jan-25-2024
4 Canon Medical System, USA, INC. II Nov-08-2022
5 Echonous Inc II Jul-10-2024
6 FUJIFILM Healthcare Americas Corporation II May-22-2024
7 FujiFilm Healthcare Americas Corporation II Nov-02-2021
8 FujiFilm Healthcare Americas Corporation II Nov-02-2021
9 GE HEALTHCARE AUSTRIA GMBH & CO II Jan-30-2024
10 GE MEDICAL SYSTEMS, ISRAEL LTD. II Sep-29-2023
11 GE Medical Systems China Co., Ltd. II Jun-26-2025
12 GE Medical Systems, LLC II Oct-15-2025
13 GE Medical Systems, LLC II Apr-11-2025
14 GE Medical Systems, LLC II Dec-22-2022
15 GE Vingmed Ultrasound As II Jul-05-2024
16 GE Vingmed Ultrasound As II Jul-10-2023
17 Hitachi Healthcare Americas Corporation II Aug-16-2021
18 Hitachi Medical Systems America Inc II Mar-19-2021
19 NovaSignal Corp. II Jun-27-2024
20 NovaSignal Corp. II Feb-01-2023
21 Philips Ultrasound Inc II Oct-16-2021
22 Philips Ultrasound Inc II Oct-07-2021
23 Philips Ultrasound Inc II Aug-16-2021
24 Philips Ultrasound Inc II Feb-03-2021
25 Philips Ultrasound Inc II Feb-02-2021
26 Philips Ultrasound Inc II Jan-14-2021
27 Philips Ultrasound, Inc III Aug-22-2025
28 Philips Ultrasound, Inc. II May-03-2024
29 Philips Ultrasound, Inc. II Nov-09-2023
30 Philips Ultrasound, LLC II Dec-31-2025
31 Philips Ultrasound, LLC II Dec-04-2025
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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