Data / Medical devices / United States / Vomark Technologies Inc

Vomark Technologies Inc: FDA-registered device maker in Wheeling, IL, United States, 18 510(k) clearances

Name: Vomark Technologies Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Vomark Technologies Inc is registered with the FDA (registration 3014639846) in Wheeling, IL, United States. It lists 4 device types. The FDA files 18 510(k) clearances under its listings, the newest dated June 9, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014639846
Address: 406 Diens Dr, Wheeling, IL, United States, 60090
Owner or operator: Vomark Technologies Inc (10062568)
Roles: Remanufacturer, Repackager or relabeler
First device listed: April 26, 2022
Registered through: 2026
Brand names listed: 12L-RS; 12S-RS; 3Sc-RS; 4C-RS; 6S-RS; 6Tc-RS; 6VT-D; 8C-RS; 9L-RS; 9T-RS; C1-5-RS; E8Cs-RS; L8-18i-RS; M5Sc-RS; ML6-15-, GE Invenia ABUS Viewer, Toshiba Aplio

Devices it lists

Device	Product code	Class	Role	Source
System, Image Processing, Radiological	LLZ	2	Repackager or relabeler	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Remanufacturer, Repackager or relabeler	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Remanufacturer, Repackager or relabeler	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Remanufacturer, Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 9, 2023	K230768	M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
September 27, 2022	K222648	5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)	IYN	Substantially Equivalent	Philips Ultrasound, LLC	accessdata.fda.gov
November 5, 2021	K212900	MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
November 9, 2018	K182857	EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
July 27, 2018	K181485	EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
May 4, 2018	K180641	Invenia ABUS Viewer	LLZ	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
January 10, 2017	K163120	EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
September 21, 2016	K161843	Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0	IYN	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
August 5, 2016	K161706	Vivid iq	IYN	Substantially Equivalent	Ge Medical Systems Ultrasound and Primary Care Diagnostics L	accessdata.fda.gov
May 15, 2014	K141093	6VT-D ULTRASOUND TRANSDUCER	ITX	Substantially Equivalent	Ge Vingmed Ultrasound AS	accessdata.fda.gov
February 6, 2013	K123992	APLIO 500/400/300 V3.0	IYN	Substantially Equivalent	Toshibamedical Systems Corporation	accessdata.fda.gov
December 21, 2012	K123754	CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
September 26, 2012	K122341	PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37	IYN	Substantially Equivalent	Hitachi Aloka Medical, Ltd.	accessdata.fda.gov
September 21, 2012	K122327	VOLUSON E6/E8/E8EXPERT/E10	IYN	Substantially Equivalent	GE Healthcare	accessdata.fda.gov
October 22, 2010	K102991	M5 DIAGNOSTIC ULTRASOUND SYSTEM	IYO	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
August 31, 2010	K101605	MYLABONE ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Esaote Europe B.V.	accessdata.fda.gov
August 15, 2008	K082185	GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2	IYO	Substantially Equivalent	Ge Medical Systems Ultrasound and Primary Care Dia	accessdata.fda.gov
October 17, 2007	K072797	GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND	IYO	Substantially Equivalent	General Electric Co.	accessdata.fda.gov

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Updated June 9, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.