GE Lunar Corp.
United StatesFDA applicant, unverified
- Devices
- 4
What GE Lunar Corp. makes
Ge Lunar Corp. develops diagnostic imaging and bone density assessment tools, including software for hip and vertebral analysis, as well as hardware devices like bone densitometers and ultrasonometers for measuring bone health metrics.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via 510(k) and PMA pathways. Its devices are listed in the FDA’s regulatory records, and the manufacturer is based in the United States.
Catalogue
Advanced Hip Assessment Software Ref K011917
Regimes: 510(k) Registry: 510(k)Dual-Energy Vertebral Assessment View Software Ref K023554
Regimes: 510(k) Registry: 510(k)Dpx Series Bravo Duo Bone Densitometer Ref K030962
Regimes: 510(k) Registry: 510(k)Achilles Express Ultrasonometer Ref P970040
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Ge Lunar Corp. have in the registry?
The registry currently lists 4 devices for Ge Lunar Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ge Lunar Corp.'s devices?
Among its 4 most recently registered devices, Ge Lunar Corp. has devices listed in FDA 510(k) (3 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Ge Lunar Corp.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Ge Lunar Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ge Lunar Corp. in the registry?
The most recently registered devices listed for Ge Lunar Corp. include ADVANCED HIP ASSESSMENT SOFTWARE, DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE, DPX SERIES BRAVO DUO BONE DENSITOMETER and ACHILLES EXPRESS ULTRASONOMETER.