# GE Medical Systems

- Location (FDA's records): Waukesha, WI
- FDA decisions: 330 (1988–2026): 329 510(k) clearances and 1 original PMA approval
- Names in FDA's records: GE Medical Systems (170); Ge Medical Systems, LLC (105); Ge Medical Systems, Inc. (55)
- Product codes: LNH (82), JAK (68), KPS (27), LLZ (19), MOS (19), IYN (12), OWB (11), IYO (11), IZI (10), KPR (9), IZL (8), IZO (4)
- 510(k) review time since 2016: median 96 days, against 108 for FDA's reviews in the same codes and years (26 of 45 faster)
- Predicates its devices cite: 281 (180 its own); citations of its devices by later devices: 488 (180 its own)
- Recalls linked to its devices: 413 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- General Electric Co.: 34 (https://510kreport.com/company/general-electric)
- GE Healthcare: 8 (https://510kreport.com/company/ge-healthcare)
- Ge Healthcare (Ge Medical Systems, LLC): 6 (https://510kreport.com/company/ge-healthcare-ge-medical-systems)
- Siemens Medical Solutions USA, Inc.: 6 (https://510kreport.com/company/siemens-medical-solutions-usa)
- General Electric Medical Systems: 4 (https://510kreport.com/company/general-electric-medical-systems)
- Ge Medical Systems F.I. Haifa: 3 (https://510kreport.com/company/ge-medical-systems-fi-haifa)
- GE Medical Systems Ultrasound and Primary Care Diagnostics: 3 (https://510kreport.com/company/ge-medical-systems-ultrasound-and-primary-care-diagnostics)
- Ge Medical Systems,Llc (Ge Healthcare): 3 (https://510kreport.com/company/ge-medical-systems-ge-healthcare)

## Firms that cite its devices most
- GE Healthcare: 37 (https://510kreport.com/company/ge-healthcare)
- General Electric Co.: 29 (https://510kreport.com/company/general-electric)
- GE Medical Systems SCS: 8 (https://510kreport.com/company/ge-medical-systems-scs)
- Ge Medical Systems F.I. Haifa: 7 (https://510kreport.com/company/ge-medical-systems-fi-haifa)
- Siemens Medical Solutions USA, Inc.: 7 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Ge Healthcare Japan Corporation: 7 (https://510kreport.com/company/ge-healthcare-japan)
- Toshiba America Medical Systems, In.C: 6 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)
- GE Medical Systems Ultrasound and Primary Care Diagnostics: 5 (https://510kreport.com/company/ge-medical-systems-ultrasound-and-primary-care-diagnostics)

## Its most-cited devices
- K960265: Advantage Windows with Functool Option (1996), cited by 13
- K012389: Revolution XR/D Digital Radiographic Imaging System (2001), cited by 9
- K010336: Advantage Windows CT/Pet Fusion (2001), cited by 9
- K051673: Xeleris 2 Processing and Review Workstation (2005), cited by 7
- K052293: GE 1.5T and 3.0T Signa HDX MR System (2005), cited by 7
- K011188: GE Logiq 9, Model 2188900-X (2001), cited by 7

## Recent decisions
- K253808: AIR Recon DL (Aug 13, 2026)
- K253560: Enhanced Boundary for PCCT (Jun 24, 2026)
- K253502: Critical Care Suite with Enteric Tube Positioning AI Algorithm (Apr 14, 2026)
- K253520: Photonova Spectra, Photonova Spectra Select (Mar 20, 2026)
- K253780: SIGNA™ Bolt (Feb 6, 2026)
- K253779: SIGNA™ Sprint Select (Feb 5, 2026)
- K252379: AIR Recon DL (Dec 23, 2025)
- K251399: SIGNA™ Sprint (Sep 11, 2025)

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