GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
United States Last updated 25 Oct 2026
- Devices
- 109
- Registries
- EUDAMEDFDA 510(k)GUDIDFDA
- FDA recalls
- 0
Catalogue
LOGIQ Totus Ref K253370
Vivid S60N, Vivid S70N Ref K200497
LOGIQ E9, LOGIQ E9 XDClear 2.0 Ref K152309
Versana Active Ref K191798
LOGIQ e Ref K151028
Vivid iq Ref K243620
LOGIQ Fortis Ref K253366
Logiq V1/ Logiq V2 Ref K153037
Versana Essential Ref K223407
Lunar Astra Ref K252718
LOGIQ Totus Ref K232381
Voluson SWIFT, Voluson SWIFT+ Ref K201828
Versana Active Ref K200998
Venue; Venue Go; Venue Fit; Venue Sprint Ref K251322
Vscan Air Ref K250087
Venue 50 Ref K152758
Vivid S60N, Vivid S70N Ref K170878
Versana Premier; Versana Premier Lotus; LOGIQ F Ref K242005
Vscan Extend Ref K180995
Vscan Air Ref K202035
Vscan Extend Ref K161588
LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 Ref K161224
LOGIQ E9, LOGIQ E9 XDClear 2.0 Ref K163077
LOGIQ E10s Ref K200119
Vivid Pioneer Ref K251169
4D View Ref K182750
ViewPoint 6 Ref K162743
Venue Sprint Ref Venue Sprint R6
Logiq E10 Ref LOGIQ E10 R2 to R3 UPG
Venue Go R4 UPG Ref Venue Go R4 UPG
Venue Go Ref Venue Go R4W
Venue Fit Ref Venue Fit R5
Venue Go Ref Venue Go R6W
Venue R5 UPG Ref Venue R5 UPG
Venue Sprint Ref Venue Sprint R5
Logiq E10 Ref 5935000E10-3
Venue Fit Ref Venue Fit R6
Logiq E10 Ref 5962802 / LOGIQ E10 R4 to R5 upgrade
Venue Ref Venue R5
Venue Go Ref Venue Go R6
Venue Go R5 UPG Ref Venue Go R5 UPG
Venue Fit Ref Venue Fit R4
Invenia ABUS Premium Ref A55007000
Venue R4 UPG Ref Venue R4 UPG
Venue Go Ref Venue Go R5W
Venue Ref Venue R5W
Venue Fit R4 UPG Ref Venue Fit R4 UPG
Caption Interpretation Ref 5700636
Invenia ABUS Ref 9563-0071-00
Showing 51-100 of 109
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
- 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