GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
United States US-MF-000016119 Last updated 23 Oct 2026
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- Devices
- 108
- Registries
- EUDAMEDFDA 510(k)GUDIDFDA
- FDA recalls
- 0
Catalogue
Venue Focus Ref Venue Focus R7W
6800000PRM Ref 6800000PRM
Vivid T8, Vivid T9 Ref K200851
Logiq P10, Logiq P9, Logiq P8 Ref K203114
Vivid E80, Vivid E90, Vivid E95 Ref K170823
Vivid T9/Vivid T8 Ref K243628
Vivid E80, Vivid E90, Vivid E95 Ref K181685
EchoPAC Software Only / EchoPAC Plug-in Ref K251342
Vivid T8, Vivid T9 Ref K221147
Venue Go Ref K261668
LOGIQ Focus Ref K261835
Voluson Expert 18 Ref K261933
EchoPAC Software Only / EchoPAC Plug-in (v211) Ref K261623
Vivid Explorer/Vivid Advanced/Vivid Focus Ref K261313
Lunar Astra Ref H8930DB
Venue Advanced Ref Venue Advanced R7W
AutoAs Ref 9685077
Venue Fit Ref Venue Fit R6W
Lung Guidance Ref 5984278
Venue Go R7 UPG Ref Venue Go R7 UPG
LOGIQ e Ref K260398
Logiq P10, Logiq P9, Logiq P8 Ref K214039
EchoPAC Software Only Ref K170847
Voluson™ Performance 16 Ref K250543
EchoPAC Software Only Ref K200852
Voluson Signature 20 Ref K233692
EchoPAC Software Only Ref K220940
Vivid E80/ Vivid E90/ Vivid E95 Ref K202658
Logiq E10 Ref K231966
Logiq E10 Ref 5969829
Venue Go R6 UPG Ref Venue Go R6 UPG
Venue R6 UPG Ref Venue R6 UPG
Logiq E10 R4R5_R6 Upg Ref 6003775
Caption AI Ref 5984922
LOGIQ E10s Ref K251963
Aria Ref K180782
Automated Aortic Stenosis Software (AutoAS) Ref K254161
Vivid S60N, Vivid S70N Ref K220619
Vscan Air Ref K231301
Versana Premier Ref K210438
Versana Premier Ref K182277
Vivid iq Ref K181727
Vivid S60N / Vivid S70N Ref K211216
ViewPoint 6 Ref K203677
Versana Balance Ref K191792
Versana Balance Ref K220446
Vivid S60N, Vivid S70N Ref K182450
LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 Ref K160277
Vivid iq Ref K221148
Showing 1-50 of 108
EUDAMED certificates
TÜV Rheinland LGA Products GmbH 0197 3 certificates
- HZ 2221349-1 Supplemented
Quality management system EU MDR
- Issued
- 7 May 2026
- Expires
- 5 Mar 2031
- Reason
- Change approved
- HZ 2237176-1 Reissued
Quality management system EU MDR
- Issued
- 22 Jul 2025
- Expires
- 21 Jul 2030
- HZ 2237176-1 Expired
Quality management system EU MDR
- Issued
- 16 Aug 2024
- Expires
- 21 Jul 2025
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What GE Medical Systems Ultrasound and Primary Care Diagnostics LLC makes
GE Medical Systems Ultrasound and Primary Care Diagnostics LLC manufactures ultrasound imaging systems and diagnostic software. Their product portfolio includes the LOGIQ, Voluson, and Vivid series of ultrasound machines, as well as Venue point-of-care systems, lung guidance tools, and EchoPAC software.
The company is based in the United States, and its devices are classified as Class II and Class IIa medical devices. These products are listed in the FDA 510(k) database and the EUDAMED registry.
Information
- Country
- United States
- Address
- 3030, Ohmeda Drive, Madison, United States
- Website
- gehealthcare.com
- [email protected]
- PRRC contact
- James Raskob
- EUDAMED SRN
- US-MF-000016119
- FDA FEI number
- 3005860720