# Ge Healthcare (Tianjin) Company Limited

- Location (FDA's records): Tianjin, CN
- FDA decisions: 6 (2019–2024): 6 510(k) clearances
- Product codes: LNH (6)
- 510(k) review time since 2016: median 74 days, against 89 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 7 (3 its own); citations of its devices by later devices: 4 (3 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ge Healthcare (Ge Medical Systems, LLC): 2 (https://510kreport.com/company/ge-healthcare-ge-medical-systems)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)

## Firms that cite its devices most
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)

## Its most-cited devices
- K202238: SIGNA Artist (2020), cited by 1
- K211980: SIGNA Prime (2022), cited by 1
- K192426: Signa Voyager, Signa Voyager Quantum (2019), cited by 1
- K223439: SIGNA Victor (2023), cited by 1

## Recent decisions
- K233728: SIGNA Champion (Jan 19, 2024)
- K223439: SIGNA Victor (Feb 13, 2023)
- K213603: SIGNA Artist Evo (Feb 11, 2022)
- K211980: SIGNA Prime (Jan 16, 2022)
- K202238: SIGNA Artist (Sep 4, 2020)
- K192426: Signa Voyager, Signa Voyager Quantum (Oct 1, 2019)

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