# GE Healthcare Finland Oy

- Location (FDA's records): Helsinki, FI
- FDA decisions: 32 (2007–2026): 32 510(k) clearances
- Product codes: MHX (15), BSZ (5), DQA (5), CCK (4), CCL (1), DXG (1), OLT (1)
- 510(k) review time since 2016: median 188 days, against 196 for FDA's reviews in the same codes and years (5 of 12 faster)
- Predicates its devices cite: 51 (25 its own); citations of its devices by later devices: 40 (25 its own)
- Recalls linked to its devices: 29 (8 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Datex-Ohmeda, Inc.: 9 (https://510kreport.com/company/datex-ohmeda)
- GE Healthcare: 8 (https://510kreport.com/company/ge-healthcare)
- Ge Medical Systems Information Technologies: 6 (https://510kreport.com/company/ge-medical-systems-information-technologies)
- Ge Medical Systems China Co., Ltd.: 1 (https://510kreport.com/company/ge-medical-systems-china)
- Pulsion Medical Systems AG: 1 (https://510kreport.com/company/pulsion-medical-systems)
- Datex-Engstrom, Inc.: 1 (https://510kreport.com/company/datex-engstrom)

## Firms that cite its devices most
- Ge Medical Systems China Co., Ltd.: 4 (https://510kreport.com/company/ge-medical-systems-china)
- Ge Medical Systems Information Technologies: 4 (https://510kreport.com/company/ge-medical-systems-information-technologies)
- Draeger Medical, Inc.: 4 (https://510kreport.com/company/draeger-medical)
- Unimed Medical Supplies, Inc.: 1 (https://510kreport.com/company/unimed-medical-supplies)
- Edwards Lifesciences, LLC: 1 (https://510kreport.com/company/edwards-lifesciences)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)

## Its most-cited devices
- K102239: Carescape Monitor B650 (2010), cited by 5
- K071097: Navigator Applications Suite (2007), cited by 4
- K081941: Navigator Applications Suite (2008), cited by 3
- K123195: Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and Accessories (2013), cited by 2
- K131223: Carescape Monitor B650 (2013), cited by 2
- K093881: Trusignal SPO2 Finger Sensor, Trusignal SPO2 Ear Sensor, Trusignal SPO2 Wrap Sensor (2010), cited by 2

## Recent decisions
- K260656: Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M (Sep 1, 2026)
- K260343: Carescape Canvas 1000; Carescape Canvas Smart Display (Aug 28, 2026)
- K223531: CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) (Apr 6, 2023)
- K213181: CARESCAPE B650, E-musb (Apr 13, 2022)
- K213336: Carescape B850, E-musb (Apr 13, 2022)
- K213363: CARESCAPE B450, E-musb (Apr 13, 2022)
- K211171: CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories (Oct 21, 2021)
- K191323: Carescape B850 (Jan 29, 2020)

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