# Ge Medical Systems Israel, Functional Imaging

- Location (FDA's records): Tirat Hacarmel, IL
- FDA decisions: 4 (2010–2025): 4 510(k) clearances
- Product codes: KPS (2), IYX (1), LLZ (1)
- 510(k) review time since 2016: median 59 days, against 65 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- GE Healthcare: 3 (https://510kreport.com/company/ge-healthcare)
- Ge Medical Systems F.I. Haifa: 2 (https://510kreport.com/company/ge-medical-systems-fi-haifa)
- Gamma Medica: 1 (https://510kreport.com/company/gamma-medica)

## Firms that cite its devices most
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)
- Gamma Medica-Ideas Incorporated: 1 (https://510kreport.com/company/gamma-medica-ideas)
- Ge Medical Systems Israel: 1 (https://510kreport.com/company/ge-medical-systems-israel)

## Its most-cited devices
- K102231: Discovery NM 750B (2010), cited by 2
- K243605: Aurora (2025), cited by 1

## Recent decisions
- K243605: Aurora (Jan 17, 2025)
- K241350: Clarify DL (Jan 3, 2025)
- K241665: Omni Legend (Aug 8, 2024)
- K102231: Discovery NM 750B (Nov 3, 2010)

Source page: https://510kreport.com/company/ge-medical-systems-israel-functional-imaging