FDA.reportPublic FDA data

VOMARK TECHNOLOGIES INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146398463014639846VOMARK TECHNOLOGIES INC1Y2026-01-01406 Diens Dr Wheeling IL US 60090

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2386041943507785K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound SystemIYN2023-06-09
2386041050553328K2226485000 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)IYN2022-09-27
2386041026776040K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound SystemIYN2021-11-05
2386041696708479K182857EPIQ 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 SystemIYN2018-11-09
2386041905025106K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound SystemIYN2018-07-27
2386041196816089K180641Invenia ABUS ViewerLLZ2018-05-04
2386041217700337K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound SystemIYN2017-01-10
2386041156410532K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0IYN2016-09-21
2386041243837867K161706Vivid iqIYN2016-08-05
2386041905303678K1410936VT-D ULTRASOUND TRANSDUCERITX2014-05-15
2386041186958624K123992APLIO 500/400/300 V3.0IYN2013-02-06
2386041427551835K123754CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-12-21
2386041706855684K122341PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37IYN2012-09-26
2386041958924173K122327VOLUSON E6/E8/E8EXPERT/E10IYN2012-09-21
2386042029327243K102991M5 DIAGNOSTIC ULTRASOUND SYSTEMIYO2010-10-22
2386041206725281K101605MYLABONE ULTRASOUND SYSTEMIYN2010-08-31
2386041545982427K082185GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2IYO2008-08-15
2386042024513187K072797GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUNDIYO2007-10-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN132023-06-09
IYO32010-10-22
LLZ12018-05-04
ITX12014-05-15