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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
ADVANCED INSTRUMENTATIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
ALPINION MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 9
ATYS
  SUBSTANTIALLY EQUIVALENT 1
BK MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 2
BUTTERFLY NETWORK, INC.
  SUBSTANTIALLY EQUIVALENT 2
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
CHISON MEDICAL IMAGING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CHISON MEDICAL TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
CLARIUS MOBILE HEALTH CORP.
  SUBSTANTIALLY EQUIVALENT 4
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 3
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ESAOTE S.P.A
  SUBSTANTIALLY EQUIVALENT 2
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 1
FUJIFILM SONOSITE INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM SONOSITE, INC.
  SUBSTANTIALLY EQUIVALENT 6
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 13
GE MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC
  SUBSTANTIALLY EQUIVALENT 3
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS,LLC
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS ULTRASOUND AND
  SUBSTANTIALLY EQUIVALENT 3
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 12
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS,
  SUBSTANTIALLY EQUIVALENT 10
GUANGZHOU SONOSTAR TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEALCERION CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HITACHI HEALTHCARE AMERICAS
  SUBSTANTIALLY EQUIVALENT 4
HITACHI HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
HITACHI, LTD
  SUBSTANTIALLY EQUIVALENT 1
INTERSON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KOELIS
  SUBSTANTIALLY EQUIVALENT 1
LELTEK INC
  SUBSTANTIALLY EQUIVALENT 2
LINKQUEST INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISONO, LLC
  SUBSTANTIALLY EQUIVALENT 2
NATIONAL TAIWAN UNIVERSITY
  SUBSTANTIALLY EQUIVALENT 1
NAVIGANT CONSULTING - ON BEHALF OF ESAOTE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
NEURAL ANALYTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS ULTRASOUND, INC.
  SUBSTANTIALLY EQUIVALENT 8
QISDA CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SAMSUNG MEDISON CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG MEDISON CO., LTD
  SUBSTANTIALLY EQUIVALENT 5
SAMSUNG MEDISON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 24
SENO MEDICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. (SIUI)
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN DELICA MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 23
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN WELL.D MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO.LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHINEERS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC
  SUBSTANTIALLY EQUIVALENT 7
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 7
SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GROUP
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS, USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
SONOSCANNER
  SUBSTANTIALLY EQUIVALENT 2
SONOSCAPE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 9
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 4
VENTRIPOINT DIAGNOSTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIASONIX LTD.
  SUBSTANTIALLY EQUIVALENT 3
VINNO TECHNOLOGY (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WINPROBE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WUHAN ZONCARE BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 146 146
2018 82 82
2019 59 59
2020 67 67
2021 213 213

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 102 102
Patient Data Problem 47 47
Device Operational Issue 46 46
Output Problem 27 27
Loss of Data 25 25
Adverse Event Without Identified Device or Use Problem 24 24
No Display/Image 21 21
Mechanical Jam 17 17
Device Displays Incorrect Message 16 16
Application Program Freezes, Becomes Nonfunctional 16 16
Fire 14 14
Signal Artifact/Noise 14 14
Display or Visual Feedback Problem 13 13
Poor Quality Image 13 13
Use of Device Problem 13 13
No Device Output 12 12
Computer Software Problem 12 12
Smoking 9 9
Data Problem 9 9
Improper Device Output 8 8
Detachment of Device or Device Component 8 8
Battery Problem 8 8
Computer Operating System Problem 8 8
Device Operates Differently Than Expected 6 6
Device Dislodged or Dislocated 6 6
Incorrect, Inadequate or Imprecise Resultor Readings 6 6
Failure to Power Up 6 6
Operating System Becomes Nonfunctional 6 6
Insufficient Information 6 6
Temperature Problem 6 6
Appropriate Term/Code Not Available 5 5
Unintended Application Program Shut Down 5 5
Unexpected Shutdown 5 5
Incorrect Measurement 5 5
Arcing 5 5
Sparking 4 4
Improper or Incorrect Procedure or Method 4 4
Inadequate User Interface 4 4
Loss of Power 4 4
Computer System Security Problem 4 4
Overheating of Device 4 4
Thermal Decomposition of Device 4 4
Erratic or Intermittent Display 4 4
Power Problem 4 4
Therapeutic or Diagnostic Output Failure 3 3
No Visual Prompts/Feedback 3 3
Intermittent Loss of Power 3 3
Noise, Audible 3 3
Circuit Failure 3 3
Electrical /Electronic Property Problem 3 3
Image Display Error/Artifact 3 3
Device Emits Odor 3 3
Visual Prompts will not Clear 3 3
Device Stops Intermittently 2 2
Device Inoperable 2 2
Application Program Problem 2 2
Device Issue 2 2
Failure to Advance 2 2
Electrical Overstress 2 2
Image Orientation Incorrect 2 2
Mechanical Problem 2 2
Failure to Run on Battery 2 2
Incorrect Software Programming Calculations 2 2
Break 2 2
Device Fell 2 2
Unintended Movement 2 2
Activation Failure 2 2
Flare or Flash 2 2
Reset Problem 2 2
Physical Property Issue 2 2
Programming Issue 1 1
Protective Measures Problem 1 1
No Apparent Adverse Event 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Program or Algorithm Execution Problem 1 1
Delayed Program or Algorithm Execution 1 1
Activation Problem 1 1
Excessive Heating 1 1
No Audible Alarm 1 1
Loss of or Failure to Bond 1 1
Use of Incorrect Control Settings 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Positioning Failure 1 1
Display Difficult to Read 1 1
Burst Container or Vessel 1 1
Electromagnetic Interference 1 1
Flushing Problem 1 1
Material Frayed 1 1
Failure to Transmit Record 1 1
Application Program Problem: Parameter Calculation Error 1 1
Peeled/Delaminated 1 1
Melted 1 1
Loose or Intermittent Connection 1 1
Output above Specifications 1 1
Electrical Power Problem 1 1
Electronic Property Issue 1 1
Fail-Safe Problem 1 1
Issue With Displayed Error Message 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 209 209
No Consequences Or Impact To Patient 167 167
No Known Impact Or Consequence To Patient 109 109
Insufficient Information 30 30
No Information 20 20
No Patient Involvement 12 12
No Code Available 11 11
Perforation 10 10
Death 7 7
Hemorrhage/Bleeding 6 6
Not Applicable 6 6
Injury 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Hyperextension 2 2
Patient Problem/Medical Problem 2 2
Missing Value Reason 2 2
Pregnancy 2 2
Laceration(s) 2 2
Misdiagnosis 2 2
Necrosis 2 2
Pain 2 2
Laceration(s) of Esophagus 2 2
Breast Cancer 2 2
Congenital Defect/Deformity 2 2
Bruise/Contusion 1 1
Cardiac Arrest 1 1
Erythema 1 1
Flatus 1 1
Headache 1 1
Pneumonia 1 1
Respiratory Distress 1 1
Seizures 1 1
Septic Shock 1 1
Shock 1 1
Thrombosis 1 1
Thrombus 1 1
Perforation of Vessels 1 1
Burning Sensation 1 1
Perforation of Esophagus 1 1
Neck Pain 1 1
Burn, Thermal 1 1
Electric Shock 1 1
Abdominal Distention 1 1
Rupture 1 1
Distress 1 1
Tingling 1 1
Cramp(s) 1 1
Dizziness 1 1
Mitral Insufficiency 1 1
Muscle Weakness 1 1
Insufficiency, Valvular 1 1
Constipation 1 1
Unspecified Hepatic or Biliary Problem 1 1
Sedation 1 1
Unspecified Tissue Injury 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 Carestream Health Inc II Jan-19-2017
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 Healthcare, LLC II Apr-11-2017
14 GE Medical Systems Ultrasound & Primary Care Diagnostics, LL II Sep-06-2018
15 Hitachi Aloka Medical, Ltd. II Mar-29-2017
16 Hitachi Healthcare Americas Corporation II Aug-16-2021
17 Hitachi Medical Systems America Inc II Mar-19-2021
18 Hitachi Medical Systems America Inc II May-12-2017
19 Konica Minolta Medical Imaging USA, Inc. II Mar-27-2018
20 Konica Minolta, Inc. II Jul-26-2017
21 Mindray DS USA, Inc. dba Mindray North America II Feb-05-2020
22 NeuroLogica Corporation II Aug-14-2019
23 Olympus Corporation of the Americas II Nov-27-2020
24 Olympus Corporation of the Americas II Mar-12-2019
25 Philips Ultrasound Inc II Oct-16-2021
26 Philips Ultrasound Inc II Oct-07-2021
27 Philips Ultrasound Inc II Aug-16-2021
28 Philips Ultrasound Inc II Feb-03-2021
29 Philips Ultrasound Inc II Feb-02-2021
30 Philips Ultrasound Inc II Jan-14-2021
31 Philips Ultrasound Inc II Aug-06-2019
32 Siemens Medical Solutions USA, Inc. II Sep-14-2021
33 Siemens Medical Solutions USA, Inc. II Apr-01-2021
34 Siemens Medical Solutions USA, Inc. II Aug-22-2019
35 Siemens Medical Solutions USA, Inc. II Mar-26-2018
36 Siemens Medical Solutions USA, Inc. II Mar-15-2018
37 Siemens Medical Solutions USA, Inc. II Apr-24-2017
38 Toshiba American Medical Systems Inc II Jun-29-2018
39 Toshiba American Medical Systems Inc II Jul-10-2017
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