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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
ALPINION MEDICAL SYSTEMS CO. LTD
  SUBSTANTIALLY EQUIVALENT 7
ALPINION MEDICAL SYSTEMS CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
BK MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 6
B-K MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 3
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
CHANG GUNG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHISON MEDICAL IMAGING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
CHISON MEDICAL TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CLARIUS MOBILE HEALTH CORP.
  SUBSTANTIALLY EQUIVALENT 4
EDAN INSTRUMENTS INC
  SUBSTANTIALLY EQUIVALENT 3
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ESAOTE
  SUBSTANTIALLY EQUIVALENT 9
ESAOTE S.P.A.
  SUBSTANTIALLY EQUIVALENT 8
ESAOTE, S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
EXACT IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
EZONO AG
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 27
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 35
HEALCERION CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HITACHI ALOKA MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 2
HITACHI HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HITACHI, LTD.
  SUBSTANTIALLY EQUIVALENT 3
KOELIS
  SUBSTANTIALLY EQUIVALENT 2
KONICA MINOLTA INC.
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDISONO, LLC
  SUBSTANTIALLY EQUIVALENT 2
METRITRACK LLC
  SUBSTANTIALLY EQUIVALENT 1
MINDRAY DS USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
NEURAL ANALYTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NEUROCHAOS SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 6
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 13
QISDA CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
RIMED LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG MEDISON CO., LTD
  SUBSTANTIALLY EQUIVALENT 8
SAMSUNG MEDISON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 20
SASET HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DELICA MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 24
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 3
SIEMENS
  SUBSTANTIALLY EQUIVALENT 16
SIEMENS CAPITAL
  SUBSTANTIALLY EQUIVALENT 11
SIEMENS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GROUP
  SUBSTANTIALLY EQUIVALENT 2
SONOSCANNER SARL
  SUBSTANTIALLY EQUIVALENT 1
SONOSCAPE COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 5
SONOSCAPE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 14
SUPERSONIC IMAGINE
  SUBSTANTIALLY EQUIVALENT 6
TELEMED
  SUBSTANTIALLY EQUIVALENT 1
TERATECH CORP.
  SUBSTANTIALLY EQUIVALENT 5
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 14
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 13
TOYOTA TSUSHO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UNITED IMAGING SYSTEMS (BEIJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VENTRIPOINT DIAGNOSTICS LTD.
  SUBSTANTIALLY EQUIVALENT 2
VIASONIX LTD.
  SUBSTANTIALLY EQUIVALENT 2
WINPROBE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Operational Issue 86
Loss of Data 45
Data Problem 45
Electrical /Electronic Property Problem 34
Device Displays Incorrect Message 17
Adverse Event Without Identified Device or Use Problem 14
Computer Software Problem 13
Device Operates Differently Than Expected 11
No Display / Image 11
Microbial Contamination of Device 10
Improper Device Output 8
Split 7
Output Problem 7
Temperature Problem 5
Overheating of Device 5
Transducer 5
Mechanical Problem 5
Insufficient Information 4
Use of Device Problem 4
Computer System Security Problem 4
Incorrect Measurement 3
Incorrect, Inadequate or Imprecise Result or Readings 3
Signal Artifact 3
Power Problem 3
Device Stops Intermittently 3
Physical Property Issue 3
Contamination / decontamination Problem 3
Improper or Incorrect Procedure or Method 2
Sparking 2
Application Program Problem: Parameter Calculation Error 2
Memory 2
Circuit Failure 2
No Device Output 2
Incorrect Software Programming Calculations 2
Poor Quality Image 2
Battery Problem 2
Intermittent loss of power 2
Device Issue 2
Break 2
Component Falling 1
Output above Specifications 1
Flare or Flash 1
Unintended Movement 1
Computer Hardware 1
Program or Algorithm Execution Problem 1
Computer Operating System Problem 1
Electronic Property Issue 1
Loss of or Failure to Bond 1
Programming Issue 1
Reset Problem 1
EKG/ECG Monitor 1
Optical Distortion 1
Application Program Problem 1
Lock 1
Use of Incorrect Control Settings 1
Application Program Freezes, Becomes Nonfunctional 1
Device Emits Odor 1
Defective Component 1
Failure to Align 1
Noise, Audible 1
Erratic or Intermittent Display 1
Monitor 1
Probe 1
Device Inoperable 1
Fire 1
Image Resolution Poor 1
Fail-Safe Problem 1
Issue With Displayed Error Message 1
Device Component Or Accessory 1
Appropriate Term/Code Not Available 1
Activation Problem 1
Inappropriate Shock 1
Total Device Problems 418

Recalls
Manufacturer Recall Class Date Posted
1 B-K Medical A/S II Aug-03-2016
2 Boston Scientific Corporation II Apr-22-2014
3 Carestream Health Inc II Jan-19-2017
4 Carestream Health Inc II Jul-18-2016
5 ESAOTE S.P.A. II Oct-23-2018
6 ESAOTE S.P.A. II Mar-20-2018
7 GE Healthcare, LLC II Jul-12-2019
8 GE Healthcare, LLC II Jun-18-2019
9 GE Healthcare, LLC II Jan-30-2019
10 GE Healthcare, LLC II Dec-07-2018
11 GE Healthcare, LLC II Apr-11-2017
12 GE Healthcare, LLC II Apr-23-2014
13 GE Medical Systems Ultrasound & Primary Care Diagnostics, LL II Sep-06-2018
14 Hitachi Aloka Medical, Ltd. II Mar-29-2017
15 Hitachi Medical Systems America Inc II May-12-2017
16 Konica Minolta Medical Imaging USA, Inc. II Mar-27-2018
17 Konica Minolta, Inc. II Jul-26-2017
18 NeuroLogica Corporation II Aug-14-2019
19 Olympus Corporation of the Americas II Mar-12-2019
20 Philips Medical Systems North America Inc. II Mar-20-2014
21 Philips Ultrasound Inc II Aug-06-2019
22 Philips Ultrasound, Inc. II Apr-13-2016
23 Philips Ultrasound, Inc. II Jan-06-2016
24 Philips Ultrasound, Inc. II May-19-2015
25 Philips Ultrasound, Inc. II May-05-2015
26 Philips Ultrasound, Inc. II Dec-16-2014
27 Siemens Medical Solutions USA, Inc. II Aug-22-2019
28 Siemens Medical Solutions USA, Inc. II Mar-26-2018
29 Siemens Medical Solutions USA, Inc. II Mar-15-2018
30 Siemens Medical Solutions USA, Inc. II Apr-24-2017
31 Siemens Medical Solutions USA, Inc. II Nov-28-2016
32 Siemens Medical Solutions USA, Inc. II May-02-2016
33 Siemens Medical Solutions USA, Inc. II Apr-27-2016
34 Siemens Medical Solutions USA, Inc. II Oct-30-2015
35 Siemens Medical Solutions USA, Inc. II Sep-17-2015
36 Siemens Medical Solutions USA, Inc. II Aug-05-2015
37 Siemens Medical Solutions USA, Inc. II Jul-30-2015
38 Siemens Medical Solutions USA, Inc. II Jul-29-2015
39 Siemens Medical Solutions USA, Inc. II Jul-02-2015
40 Siemens Medical Solutions USA, Inc. II May-06-2015
41 Siemens Medical Solutions USA, Inc. II Feb-05-2015
42 Siemens Medical Solutions USA, Inc. II Jul-01-2014
43 Siemens Medical Solutions USA, Inc. II May-28-2014
44 Siemens Medical Solutions USA, Inc. II May-28-2014
45 Siemens Medical Solutions USA, Inc. II Apr-24-2014
46 Siemens Medical Solutions USA, Inc. II Apr-03-2014
47 Siemens Medical Solutions USA, Inc. II Jan-24-2014
48 Siemens Medical Solutions USA, Inc. II Jan-24-2014
49 Toshiba American Medical Systems Inc II Jun-29-2018
50 Toshiba American Medical Systems Inc II Jul-10-2017
51 Toshiba American Medical Systems Inc II Aug-16-2016

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