# Ge Healthcare (Ge Medical Systems, LLC)

- Location (FDA's records): Waukesha, WI
- FDA decisions: 6 (2013–2022): 6 510(k) clearances
- Product codes: LNH (6)
- 510(k) review time since 2016: median 59 days, against 121 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 12 (1 its own)
- Recalls linked to its devices: 46 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- GE Medical Systems: 5 (https://510kreport.com/company/ge-medical-systems)
- Ge Hangwei Medical Systems Co., Ltd.: 1 (https://510kreport.com/company/ge-hangwei-medical-systems)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)

## Firms that cite its devices most
- GE Medical Systems: 6 (https://510kreport.com/company/ge-medical-systems)
- Ge Medical Systems,Llc (Ge Healthcare): 2 (https://510kreport.com/company/ge-medical-systems-ge-healthcare)
- Ge Healthcare (Tianjin) Company Limited: 2 (https://510kreport.com/company/ge-healthcare-tianjin)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)

## Its most-cited devices
- K193282: SIGNA Premier (2020), cited by 5
- K143251: SIGNA Creator, SIGNA Explorer (2015), cited by 2
- K132376: Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5T (2013), cited by 2
- K213668: SIGNA Hero (2022), cited by 2
- K123522: Optima MR450W (2013), cited by 1

## Recent decisions
- K213668: SIGNA Hero (Jan 20, 2022)
- K202966: SIGNA Architect (Nov 13, 2020)
- K193282: SIGNA Premier (Apr 10, 2020)
- K143251: SIGNA Creator, SIGNA Explorer (Feb 4, 2015)
- K132376: Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5T (Nov 15, 2013)
- K123522: Optima MR450W (Mar 13, 2013)

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