GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
United States Last updated 25 Oct 2026
- Devices
- 109
- Registries
- EUDAMEDGUDIDFDA
- FDA recalls
- 0
Catalogue
Venue Ref Venue R6
Venue Fit UPG Ref Venue Fit UPG
Logiq E10 Ref 5935000E10-4
Venue Fit Ref Venue Fit R4W
Caption Guidance Ref 5700635
Venue Ref Venue R4
Logiq E10 Ref LOGIQ E10 R5 / 5935000E10-5
Logiq E10 Ref LOGIQ E10 R4 to R5 UPG
Invenia ABUS Prime Ref A56007000
Showing 101-109 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
Related companies
Authorised representatives
Notified bodies
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