System, Imaging, Pulsed Doppler, Ultrasonic

Device Code: 5328

Product Code(s): IYN

Device Classification Information

Device Type ID5328
Device NameSystem, Imaging, Pulsed Doppler, Ultrasonic
Regulation DescriptionUltrasonic Pulsed Doppler Imaging System.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number892.1550 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeIYN
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID5328
DeviceSystem, Imaging, Pulsed Doppler, Ultrasonic
Product CodeIYN
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionUltrasonic Pulsed Doppler Imaging System.
CFR Regulation Number892.1550 [🔎]
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
 3
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
 3
EDAN INSTRUMENTS INC
 
SUBSTANTIALLY EQUIVALENT
 3
EDAN INSTRUMENTS, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
ESAOTE
 
SUBSTANTIALLY EQUIVALENT
 7
ESAOTE S.P.A.
 
SUBSTANTIALLY EQUIVALENT
 7
ESAOTE, S.P.A.
 
SUBSTANTIALLY EQUIVALENT
 2
EZONO AG
 
SUBSTANTIALLY EQUIVALENT
 1
FUJIFILM CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 4
GE HEALTHCARE
 
SUBSTANTIALLY EQUIVALENT
 26
GENERAL ELECTRIC CO.
 
SUBSTANTIALLY EQUIVALENT
 34
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
 5
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
 
SUBSTANTIALLY EQUIVALENT
 12
QISDA CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 2
RIMED LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
SAMSUNG MEDISON CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 7
SAMSUNG MEDISON CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 17
SASET HEALTHCARE
 
SUBSTANTIALLY EQUIVALENT
 1
SHENZHEN DELICA MEDICAL EQUIPMENT CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 22
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
 14
SIEMENS CAPITAL
 
SUBSTANTIALLY EQUIVALENT
 10
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
 5
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
 1
WINPROBE CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Device Operational Issue
 86
Data Problem
 45
Loss Of Data
 43
Electrical /Electronic Property Problem
 34
Device Displays Incorrect Message
16
Adverse Event Without Identified Device Or Use Problem
 12
Computer Software Problem
 12
Microbial Contamination Of Device
10
No Display / Image
 9
Device Operates Differently Than Expected
 9
Improper Device Output
 8
Split
 7
Output Problem
 7
Temperature Problem
 5
Overheating Of Device
 5
Mechanical Problem
 5
Transducer
 5
Computer System Security Problem
 4
Device Stops Intermittently
 3
Incorrect Measurement
 3
Signal Artifact
 3
Physical Property Issue
 3
Contamination / Decontamination Problem
3
Incorrect, Inadequate Or Imprecise Result Or Readings
 3
No Device Output
2
Insufficient Information
 2
Break
 2
Device Issue
 2
Intermittent Loss Of Power
 2
Use Of Device Problem
 2
Improper Or Incorrect Procedure Or Method
 2
Application Program Problem: Parameter Calculation Error
 2
Power Problem
 2
Incorrect Software Programming Calculations
 2
Sparking
 2
Memory
 1
Fire
 1
Programming Issue
 1
Device Component Or Accessory
 1
Electronic Property Issue
 1
Inappropriate Shock
 1
Lock
 1
Image Resolution Poor
 1
Defective Component
 1
Battery Problem
 1
Device Inoperable
 1
Loss Of Or Failure To Bond
 1
Appropriate Term/Code Not Available
 1
Fail-Safe Problem
 1
Output Above Specifications
 1
Optical Distortion
 1
Application Program Freezes, Becomes Nonfunctional
1
Circuit Failure
 1
Program Or Algorithm Execution Problem
1
Computer Operating System Problem
 1
Device Emits Odor
 1
Monitor
 1
Poor Quality Image
1
Reset Problem
 1
Noise, Audible
 1
EKG/ECG Monitor
 1
Probe
 1
Failure To Align
 1
Component Falling
 1
Total Device Problems 391
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 Jan-30-2019
8
GE Healthcare, LLC
 II Dec-07-2018
9
GE Healthcare, LLC
 II Apr-11-2017
10
GE Healthcare, LLC
 II Apr-23-2014
11
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
 II Sep-06-2018
12
Hitachi Aloka Medical, Ltd.
 II Mar-29-2017
13
Hitachi Medical Systems America Inc
 II May-12-2017
14
Konica Minolta Medical Imaging USA, Inc.
 II Mar-27-2018
15
Konica Minolta, Inc.
 II Jul-26-2017
16
Olympus Corporation Of The Americas
 II Mar-12-2019
17
Philips Medical Systems North America Inc.
 II Mar-20-2014
18
Philips Ultrasound, Inc.
 II Apr-13-2016
19
Philips Ultrasound, Inc.
 II Jan-06-2016
20
Philips Ultrasound, Inc.
 II May-19-2015
21
Philips Ultrasound, Inc.
 II May-05-2015
22
Philips Ultrasound, Inc.
 II Dec-16-2014
23
Siemens Medical Solutions USA, Inc.
 II Mar-26-2018
24
Siemens Medical Solutions USA, Inc.
 II Mar-15-2018
25
Siemens Medical Solutions USA, Inc.
 II Apr-24-2017
26
Siemens Medical Solutions USA, Inc.
 II Nov-28-2016
27
Siemens Medical Solutions USA, Inc.
 II May-02-2016
28
Siemens Medical Solutions USA, Inc.
 II Apr-27-2016
29
Siemens Medical Solutions USA, Inc.
 II Oct-30-2015
30
Siemens Medical Solutions USA, Inc.
 II Sep-17-2015
31
Siemens Medical Solutions USA, Inc.
 II Aug-05-2015
32
Siemens Medical Solutions USA, Inc.
 II Jul-30-2015
33
Siemens Medical Solutions USA, Inc.
 II Jul-29-2015
34
Siemens Medical Solutions USA, Inc.
 II Jul-02-2015
35
Siemens Medical Solutions USA, Inc.
 II May-06-2015
36
Siemens Medical Solutions USA, Inc.
 II Feb-05-2015
37
Siemens Medical Solutions USA, Inc.
 II Jul-01-2014
38
Siemens Medical Solutions USA, Inc.
 II May-28-2014
39
Siemens Medical Solutions USA, Inc.
 II May-28-2014
40
Siemens Medical Solutions USA, Inc.
 II Apr-24-2014
41
Siemens Medical Solutions USA, Inc.
 II Apr-03-2014
42
Siemens Medical Solutions USA, Inc.
 II Jan-24-2014
43
Siemens Medical Solutions USA, Inc.
 II Jan-24-2014
44
Toshiba American Medical Systems Inc
 II Jun-29-2018
45
Toshiba American Medical Systems Inc
 II Jul-10-2017
46
Toshiba American Medical Systems Inc
 II Aug-16-2016
TPLC Last Update: 2019-04-02 21:04:25
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