# GE Medical Systems SCS

- Location (FDA's records): Buc, FR
- FDA decisions: 38 (2008–2026): 38 510(k) clearances
- Product codes: JAK (16), LLZ (12), OWB (5), KPS (3), MUE (2)
- 510(k) review time since 2016: median 136 days, against 131 for FDA's reviews in the same codes and years (10 of 28 faster)
- Predicates its devices cite: 51 (13 its own); citations of its devices by later devices: 29 (13 its own)
- Recalls linked to its devices: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- GE Healthcare: 14 (https://510kreport.com/company/ge-healthcare)
- GE Medical Systems: 8 (https://510kreport.com/company/ge-medical-systems)
- General Electric Medical Systems: 6 (https://510kreport.com/company/general-electric-medical-systems)
- Siemens Medical Solutions USA, Inc.: 2 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Invivo Corporation: 1 (https://510kreport.com/company/invivo)
- Gef Medical Systems Scs: 1 (https://510kreport.com/company/gef-medical-systems-scs)
- Siemens Medical Solution USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solution-usa)
- Ge Healthcare (Ge Medical Systems Scs): 1 (https://510kreport.com/company/ge-healthcare-ge-medical-systems-scs)

## Firms that cite its devices most
- GE Healthcare: 3 (https://510kreport.com/company/ge-healthcare)
- Philips Medical Systems Nederland B.V.: 2 (https://510kreport.com/company/philips-medical-systems-nederland)
- GE Medical Systems: 2 (https://510kreport.com/company/ge-medical-systems)
- Vuze Medical, Ltd.: 1 (https://510kreport.com/company/vuze-medical)
- Vital Images, Inc.: 1 (https://510kreport.com/company/vital-images)
- Mim Software, Inc.: 1 (https://510kreport.com/company/mim-software)
- Philips Medical Systems North America, Inc.: 1 (https://510kreport.com/company/philips-medical-systems-north-america)
- Canon Medical Informatics, Inc.: 1 (https://510kreport.com/company/canon-medical-informatics)

## Its most-cited devices
- K092639: Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision, Model S18751EP (2009), cited by 7
- K073153: Cardiq Function Xpress (2008), cited by 2
- K120910: Cardiq Xpress 2.0 with Snapshot Freeze Option Cardiq Xpress 2.0 Reveal (2012), cited by 2
- K121827: Gsi Viewer with Vue Option (2012), cited by 2
- K113403: GE Discovery Igs Angiographic,Fluoroscopic X-Ray System (2012), cited by 2
- K213725: CardIQ Suite (2022), cited by 2

## Recent decisions
- K253770: CardIQ Suite (Jul 21, 2026)
- K260087: Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright (Mar 24, 2026)
- K251199: Allia Moveo (Dec 9, 2025)
- K243672: CardIQ Suite (Jun 18, 2025)
- K243651: VersaViewer (Apr 21, 2025)
- K243446: 3DXR (Feb 25, 2025)
- K233731: CardIQ Suite (Aug 1, 2024)
- K233714: BreView (Jan 25, 2024)

Source page: https://510kreport.com/company/ge-medical-systems-scs