# Ge Medical Systems F.I. Haifa

- Location (FDA's records): Tirat Hacarmel, IL
- FDA decisions: 17 (1998–2013): 17 510(k) clearances
- Product codes: KPS (14), LLZ (3)
- Predicates its devices cite: 30 (12 its own); citations of its devices by later devices: 40 (12 its own)
- Recalls linked to its devices: 51 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- GE Medical Systems: 7 (https://510kreport.com/company/ge-medical-systems)
- Elscint, Inc.: 4 (https://510kreport.com/company/elscint)
- Siemens Medical Solutions USA, Inc.: 2 (https://510kreport.com/company/siemens-medical-solutions-usa)
- General Electric Co.: 2 (https://510kreport.com/company/general-electric)
- Nuclear Diagnostics, Inc.: 1 (https://510kreport.com/company/nuclear-diagnostics)
- Nuclear Cardiology Systems, Inc.: 1 (https://510kreport.com/company/nuclear-cardiology-systems)
- Spectrum Dynamics, Ltd.: 1 (https://510kreport.com/company/spectrum-dynamics)

## Firms that cite its devices most
- GE Healthcare: 5 (https://510kreport.com/company/ge-healthcare)
- Hermes Medical Solutions AB: 4 (https://510kreport.com/company/hermes-medical-solutions)
- GE Medical Systems: 3 (https://510kreport.com/company/ge-medical-systems)
- Mirada Medical, Ltd.: 3 (https://510kreport.com/company/mirada-medical)
- Ge Medical Systems Israel, Functional Imaging: 2 (https://510kreport.com/company/ge-medical-systems-israel-functional-imaging)
- Siemens Medical Solutions USA, Inc.: 2 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Digirad Corp.: 2 (https://510kreport.com/company/digirad)
- Ani-Kal Ii, LLC: 1 (https://510kreport.com/company/ani-kal-ii)

## Its most-cited devices
- K130884: Xeleris 3.1 Processing and Review Workstation (2013), cited by 6
- K991841: Hawkeye Option for Dual-Head Variable Angle Gamma Camera (1999), cited by 6
- K093982: Xeleris 3 Processing and Review Workstation (2010), cited by 5
- K003264: QPS/BPGS/Moco Processing Applications for Entegra Workstation (2000), cited by 4
- K022960: GE Quasar Nuclear Medicine System (2002), cited by 4
- K093514: Discovery Model NM/CT 670 (2009), cited by 4

## Recent decisions
- K130884: Xeleris 3.1 Processing and Review Workstation (Apr 12, 2013)
- K093982: Xeleris 3 Processing and Review Workstation (Jan 8, 2010)
- K093514: Discovery Model NM/CT 670 (Dec 10, 2009)
- K083504: GE Discovery NM/CT 570C (Dec 12, 2008)
- K080124: Ventri 1.1 (Jan 31, 2008)
- K051855: Ventri (Aug 2, 2005)
- K043381: Infinia Lightspeed (Dec 23, 2004)
- K033874: Myolight (Dec 30, 2003)

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