GE Healthcare (GE Medical Systems, LLC)
United StatesFDA applicant, unverified
- Devices
- 8
What GE Healthcare (GE Medical Systems, LLC) makes
The company manufactures magnetic resonance imaging (MRI) systems, including 1.5T and 3.0T scanners designed for clinical and research applications. These devices include models like the Discovery MR750, SIGNA Creator, and SIGNA Architect, which support advanced imaging techniques for diagnostic purposes.
These MRI systems are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance process. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
SIGNA Creator, SIGNA Explorer Ref K143251
Regimes: 510(k) Registry: 510(k)Optima MR450W Ref K123522
Regimes: 510(k) Registry: 510(k)SIGNA Architect Ref K202966
Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDIDSIGNA Hero Ref K213668
Regimes: CE MDR 510(k) Registry: 510(k)Ready View Ref K110573
Regimes: 510(k) Registry: 510(k)Ready View Ref K113456
Regimes: CE MDR 510(k) Registry: 510(k)SIGNA Premier Ref K193282
Regimes: CE MDR 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ge Healthcare (Ge Medical Systems, LLC) have in the registry?
The registry currently lists 8 devices for Ge Healthcare (Ge Medical Systems, LLC). Devices recorded under merged duplicate company entries are counted once.
Which registries list Ge Healthcare (Ge Medical Systems, LLC)'s devices?
Among its 8 most recently registered devices, Ge Healthcare (Ge Medical Systems, LLC) has devices listed in EUDAMED (1 device), FDA 510(k) (8 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Ge Healthcare (Ge Medical Systems, LLC)'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Ge Healthcare (Ge Medical Systems, LLC)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ge Healthcare (Ge Medical Systems, LLC) in the registry?
The most recently registered devices listed for Ge Healthcare (Ge Medical Systems, LLC) include DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T, SIGNA Creator, SIGNA Explorer, OPTIMA MR450W and SIGNA Architect.