Product code IYN

Device name: System, Imaging, Pulsed Doppler, Ultrasonic
Medical specialty: Radiology
Device class: 2
Regulation number: 892.1550
Review panel: RA
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

PMA, Device, Applicant table
PMA	Device	Applicant	Decision date
P940005S002	HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD	Advanced Technology Laboratories, Inc.	1998-07-21
P940005S001	HDI 3000 ULTRASOUND SYSTEM	Advanced Technology Laboratories, Inc.	1996-12-23
P940005	ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM	Advanced Technology Laboratories, Inc.	1996-04-11

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K261313	Vivid Explorer/Vivid Advanced/Vivid Focus	GE Medical Systems Ultrasound and Primary Care Diagnostics	2026-09-02
K254027	Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/...	Sonoscape Medical Corp.	2026-08-24
K261668	Venue Go	GE Medical Systems Ultrasound and Primary care Diagnostics, LLC	2026-08-07
K262311	Alturion Series Diagnostic Ultrasound System	Philips Ultrasound, LLC	2026-08-04
K261288	Handheld Ultrasound Scanner	IMGFAX CO., LTD.	2026-07-30
K261835	LOGIQ Focus	GE Medical Systems Ultrasound and Primary Care Diagnostics	2026-07-30
K261412	V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnosti...	Samsung Medison Co., Ltd.	2026-07-28
K261211	Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System	Philips Ultrasound, LLC	2026-07-27
K261081	Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)	Beijing Konted Medical Technology Co.,Ltd	2026-07-23
K261272	ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system	Esonic Technology (Wuhan) Co., Ltd.	2026-07-23
K260667	Alturion Series Diagnostic Ultrasound System	Philips Ultrasound, LLC	2026-06-29
K260844	ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2026-06-16
K260748	ES-Series	E-Scopics	2026-06-09
K260123	EPIQ Series Diagnostic Ultrasound System	Philips Ultrasound, LLC	2026-05-27
K260680	EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems	Philips Ultrasound, LLC	2026-05-27
K260398	LOGIQ e	GE Medical Systems Ultrasound and Primary Care Diagnostics	2026-05-26
K253949	SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3...	CHISON Medical Technologies Co., Ltd.	2026-05-22
K253720	uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite	Wuhan United Imaging Healthcare Co.,Ltd	2026-05-21
K253716	uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Ve...	Wuhan United Imaging Healthcare Co.,Ltd	2026-05-15
K254028	Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Aut...	Sonoscape Medical Corp.	2026-05-15
K260111	Palmtop Ultrasound Diagnostic System (MT10P/MT10)	Mytech Intelligence (Shenzhen) Co., Ltd.	2026-05-14
K260846	Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic ...	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2026-05-11
K252558	Lumify Diagnostic Ultrasound System	Philips Ultrasound, LLC	2026-05-05
K261132	Healium Intelliscan LX192LC	Healium Intelliscan Corporation	2026-05-05
K260589	ES-Series	E-Scopics	2026-04-29
K253288	6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)	Esaote, S.p.A.	2026-04-06
K252709	Wireless Probe Type Ultrasound Scanner	Xuzhou Yongkang Electronic Science Technology Co., Ltd.	2026-04-02
K252148	Butterfly Gestational Age Tool	Butterfly Network, Inc.	2026-03-27
K253595	EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System	Philips Ultrasound, LLC	2026-03-27
K254099	EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH...	Samsung Medison Co., Ltd.	2026-03-27

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
08800357308208	V8 ONE Diagnostic Ultrasound System	SAMSUNG MEDISON CO., LTD.	2026-08-18
08800357300165	V7 ONE Diagnostic Ultrasound System	SAMSUNG MEDISON CO., LTD.	2026-08-18
08800357291937	V6 ONE Diagnostic Ultrasound System	SAMSUNG MEDISON CO., LTD.	2026-08-18
08800010500840	SonoSync+	SAMSUNG MEDISON CO., LTD.	2026-08-18
00195278439352	LOGIQ	GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC	2025-12-05
00195278723963	NA	GE Healthcare Japan Corporation	2025-10-15
00884838129276	Ultrasound Workspace	Philips Ultrasound LLC	2025-08-29
00195278875860	Vscan	GE Vingmed Ultrasound A/S	2025-07-04
00195278910509	Voluson	GE Ultrasound Korea Ltd.	2025-06-04
00884838125186	Ultrasound Workspace	Philips Ultrasound LLC	2025-03-24
00195278814685	Voluson	GE Healthcare Austria GmbH & Co OG	2025-01-08
00195278770271	Voluson	GE Healthcare Austria GmbH & Co OG	2025-01-07
00195278674197	LOGIQ	GE Medical Systems (China) Co.,Ltd.	2023-12-20
04953170437700	WATER RESISTANT CAP	OLYMPUS MEDICAL SYSTEMS CORP.	2023-04-22
00195278421388	Vivid	GE Medical Systems (China) Co.,Ltd.	2022-08-30
00195278422279	Vivid	GE Medical Systems (China) Co.,Ltd.	2022-08-30
00195278422286	Vivid	GE Medical Systems (China) Co.,Ltd.	2022-08-30
00195278347473	Voluson	GE Healthcare Austria GmbH & Co OG	2022-08-16
00195278347480	Voluson	GE Healthcare Austria GmbH & Co OG	2022-08-16
00195278388483	NA	GE Vingmed Ultrasound A/S	2022-07-29
00195278347497	Voluson	GE Healthcare Austria GmbH & Co OG	2022-06-14
00195278384041	LOGIQ	GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC	2021-11-15
00195278435743	Vivid	GE Vingmed Ultrasound A/S	2021-06-24
04953170061912	Balloon Applicator	OLYMPUS MEDICAL SYSTEMS CORP.	2017-10-12
04953170062063	Channel Plug	OLYMPUS MEDICAL SYSTEMS CORP.	2017-10-12
04953170065385	PROBE/IRRIGATION PLUG	OLYMPUS MEDICAL SYSTEMS CORP.	2017-10-12
04953170143670	WATER-RESISTANT CAP	OLYMPUS MEDICAL SYSTEMS CORP.	2017-10-12
04953170264986	SPARE FUSE	OLYMPUS MEDICAL SYSTEMS CORP.	2017-10-12
07540205000397	Clarius Ultrasound Scanner	Clarius Mobile Health Corp	2017-04-25
07540205000403	Clarius Ultrasound Scanner	Clarius Mobile Health Corp	2017-04-25

Product code IYN

Related PMA Records#

Related 510(k) Records#

Related GUDID Devices#