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
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
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
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
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
K261132	Healium Intelliscan LX192LC	Healium Intelliscan Corporation	2026-05-05
K252558	Lumify Diagnostic Ultrasound System	Philips Ultrasound, LLC	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
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
K252148	Butterfly Gestational Age Tool	Butterfly Network, Inc.	2026-03-27
K260673	LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power	GE Medical Systems Ultrasound and Primary Care Diagnostics	2026-03-24
K252433	Sonio Detect (v3)	Sonio	2026-03-16
K260595	Sonosite iLOOK Ultrasound System	FUJIFILM Sonosite, Inc.	2026-03-10
K253049	Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2026-02-11
K253597	Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System	Canon Medical Systems Corporation	2026-01-20
K253370	LOGIQ Totus	GE Medical Systems Ultrasound and Primary Care Diagnostics	2026-01-08
K253366	LOGIQ Fortis	GE Medical Systems Ultrasound and Primary Care Diagnostics	2026-01-07
K252018	HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	2026-01-05
K251268	Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)	Edan Instruments, Inc.	2025-12-23
K252557	Lumify Diagnostic Ultrasound System	Philips Ultrasound, LLC	2025-12-22
K250959	BioticsAI	Bioticsai, Inc.	2025-12-22
K252498	Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 S...	Sonoscape Medical Corp.	2025-12-05
K250791	ASUS Ultrasound Imaging System (LU800 series)	Asustek Computer, Inc.	2025-12-04
K251601	Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2025-12-03
K253310	7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)	Esaote, S.p.A.	2025-11-25
K252328	Voluson Expert 18; Voluson Expert 20; Voluson Expert 22	GE Medical Systems Ultrasound and Primary Care Diagnostics	2025-11-24

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
08056304450296	MyLabSix CrystallLine	ESAOTE SPA	2016-11-29
08056304450432	MyLabSix	Esaote Europe B.V.	2016-09-27
08056304450869	MyLab25 Gold	ESAOTE SPA	2016-09-27
08056304450791	MyLab60	ESAOTE SPA	2016-09-27
08056304450777	MyLab70 XVision	ESAOTE SPA	2016-09-27
08056304450753	MyLab70 XVG	ESAOTE SPA	2016-09-27
08056304450593	Main Unit MyLabOne Double battery	Esaote Europe B.V.	2016-09-27
08056304450562	MyLabTouch USA	Esaote Europe B.V.	2016-09-27
08056304450555	MyLabOne Vascular USA	Esaote Europe B.V.	2016-09-27
08056304450548	MyLabOne Musculoskeletal USA	Esaote Europe B.V.	2016-09-27
08056304450531	MyLabTouch	Esaote Europe B.V.	2016-09-27
08056304450517	MyLabOne reg. Anestesia USA	Esaote Europe B.V.	2016-09-27
08056304450500	MyLabOne Vascular	Esaote Europe B.V.	2016-09-27
08056304450494	MyLabOne Musculoskeletal	Esaote Europe B.V.	2016-09-27
08056304450487	MyLabSat	Esaote Europe B.V.	2016-09-27
08056304450470	MyLabOne reg. Anestesia	Esaote Europe B.V.	2016-09-27
08056304450005	MyLabTwice	ESAOTE SPA	2016-09-27
08056304450425	MyLab40 Basic Unit	Esaote Europe B.V.	2016-09-27
08056304450401	MyLab20 Plus	Esaote Europe B.V.	2016-09-27
08056304450395	MyLab40	Esaote Europe B.V.	2016-09-27
08056304450388	MyLab40 eHD	Esaote Europe B.V.	2016-09-27
08056304450364	MyLabGamma	ESAOTE SPA	2016-09-27
08056304450340	"MyLabSeven LCD 19"""	ESAOTE SPA	2016-09-27
08056304450333	MyLabSeven	ESAOTE SPA	2016-09-27
08056304450319	MyLabClass C	ESAOTE SPA	2016-09-27
08056304450302	MyLabClass C Advanced	ESAOTE SPA	2016-09-27
08056304450241	MyLabFive BASIC UNIT	Esaote Europe B.V.	2016-09-27
08056304450227	MyLabFive	Esaote Europe B.V.	2016-09-27
08056304450043	MyLabSat USA	Esaote Europe B.V.	2016-09-27
08056304450012	MyLabAlpha	ESAOTE SPA	2016-09-27

Product code IYN

Related PMA Records#

Related 510(k) Records#

Related GUDID Devices#