# GE Healthcare

- Location (FDA's records): Wauwatosa, WI
- FDA decisions: 172 (2000–2026): 169 510(k) clearances and 3 original PMA approvals
- Names in FDA's records: GE Healthcare (171); Ge Healthcare GmbH (1)
- Product codes: IYN (52), LLZ (23), KPS (12), MUE (10), MHX (10), JAK (7), OWB (5), LNH (5), MSX (5), DQK (4), CCK (3), FLL (3)
- 510(k) review time since 2016: median 63 days, against 90 for FDA's reviews in the same codes and years (33 of 49 faster)
- Predicates its devices cite: 289 (133 its own); citations of its devices by later devices: 337 (133 its own)
- Recalls linked to its devices: 259 (10 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- GE Medical Systems: 37 (https://510kreport.com/company/ge-medical-systems)
- General Electric Co.: 17 (https://510kreport.com/company/general-electric)
- Datex-Ohmeda, Inc.: 17 (https://510kreport.com/company/datex-ohmeda)
- Ge Medical Systems Information Technologies: 8 (https://510kreport.com/company/ge-medical-systems-information-technologies)
- General Electric Medical Systems: 7 (https://510kreport.com/company/general-electric-medical-systems)
- Ge Medical Systems F.I. Haifa: 5 (https://510kreport.com/company/ge-medical-systems-fi-haifa)
- Ge Vingmed Ultrasound AS: 4 (https://510kreport.com/company/ge-vingmed-ultrasound)
- Deroyal Industries, Inc.: 4 (https://510kreport.com/company/deroyal-industries)

## Firms that cite its devices most
- GE Medical Systems Ultrasound and Primary Care Diagnostics: 25 (https://510kreport.com/company/ge-medical-systems-ultrasound-and-primary-care-diagnostics)
- Samsung Medison Co., Ltd.: 15 (https://510kreport.com/company/samsung-medison)
- GE Medical Systems SCS: 14 (https://510kreport.com/company/ge-medical-systems-scs)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 12 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- GE Medical Systems: 8 (https://510kreport.com/company/ge-medical-systems)
- GE Healthcare Finland Oy: 8 (https://510kreport.com/company/ge-healthcare-finland)
- Toshibamedical Systems Corporation: 8 (https://510kreport.com/company/toshibamedical-systems)
- Toshiba America Medical Systems, In.C: 5 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)

## Its most-cited devices
- K113690: GE Logiq I, Logiq E and Vivid E (2011), cited by 12
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), cited by 10
- K142160: Logiq E9 Diagnostic Ultrasound System (2014), cited by 10
- K051092: Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov, E-Caio, E-Covx, E-Cov, E-CO & Accesacc (2005), cited by 8
- K052412: Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ (2005), cited by 8
- K052995: Advantage Workstation 4.3. (2005), cited by 8

## Recent decisions
- K253639: View (Jan 8, 2026)
- K242925: MR Contour DL (Apr 1, 2025)
- K241300: ViewPoint 6 (Jul 2, 2024)
- K232346: Digital Expert Access with Remote Scanning (Oct 27, 2023)
- K223212: Precision DL (Apr 27, 2023)
- K221680: Xeleris V Processing and Review System (Mar 1, 2023)
- K221932: Omni Legend (Sep 2, 2022)
- K213689: Voluson P6, Voluson P8 (Feb 17, 2022)

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