System, Imaging, Pulsed Doppler, Ultrasonic

Device Code: 5328

Product Code(s): IYN

Device Classification Information

• Device Type ID: 5328
• Device Name: System, Imaging, Pulsed Doppler, Ultrasonic
• Regulation Description: Ultrasonic Pulsed Doppler Imaging System.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 892.1550 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: IYN
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 12-105 NEMA UD 2-2004 (R2009)
  Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment Revision 3
• 12-228 IEC 61391-2 Edition 1.0 2010-01
  Ultrasonics - Pulse-echo Scanners - Part 2: Measurement Of Maximum Depth Of Penetration And Local Dynamic Range
• 12-277 IEC 62127-1 Edition 1.1 2013-02
  Ultrasonics -- Hydrophones -- Part 1: Measurement And Characterization Of Medical Ultrasonic Fields Up To 40 MHz
• 12-279 IEC 62127-03 Edition 1.1 2013-05
  Ultrasonics -- Hydrophones -- Part 3: Properties Of Hydrophones For Ultrasonic Fields Up To 40 MHz
• 12-291 IEC 62127-2 Edition 1.1 2013-02
  Ultrasonics -- Hydrophones -- Part 2: Calibration For Ultrasonic Fields Up To 40 MHz
• 12-292 IEEE Std 3333.2.1-2015
  IEEE Recommended Practice For Three-Dimensional (3D) Medical Modeling
• 12-293 IEC 60601-2-37 Edition 2.1 2015
  Medical Electrical Equipment - Part 2-37: Particular Requirements For The Basic Safety And Essential Performance Of Ultrasonic Medical Diagnostic And Monitoring Equipment
• 12-312 IEC 61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION
  Ultrasonics - Pulse-echo Scanners - Part 1: Techniques For Calibrating Spatial Measurement Systems And Measurement Of System Point-spread Function Response
• 12-316 IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION
  Ultrasonics - Field Characterization - Test Methods For The Determination Of Thermal And Mechanical Indices Related To Medical Diagnostic Ultrasonic Fields

Total Product Life Cycle

• Device Type ID: 5328
• Device: System, Imaging, Pulsed Doppler, Ultrasonic
• Product Code: IYN
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Ultrasonic Pulsed Doppler Imaging System.
• CFR Regulation Number: 892.1550 [🔎]

Premarket Reviews
Manufacturer	Decision
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