Osteometer Meditech A/S
Country not established
- Devices
- 3
What Osteometer Meditech A/S makes
The company manufactures bone densitometers, including the DTX-200 and DTX-100 models, which measure bone mineral density to assess osteoporosis and fracture risk. It also produces the DTU-One ultrasound scanner, a portable device used for peripheral bone density evaluations at sites like the heel or wrist.
These devices are classified as Class II under FDA regulations and are authorised through 510(k) clearances and PMA submissions. The company is based in the United States and its products are listed in the FDA’s regulatory databases.
Catalogue
Dtx-200 Bone Densitometer Ref K964562
Regimes: 510(k) Registry: 510(k)Dtx-100 Bone Densitometer Ref K963789
Regimes: 510(k) Registry: 510(k)Dtu-One Ultrasound Scanner Ref P980010
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Osteometer Meditech A/S have in the registry?
The registry currently lists 3 devices for Osteometer Meditech A/S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Osteometer Meditech A/S's devices?
Among its 3 most recently registered devices, Osteometer Meditech A/S has devices listed in FDA 510(k) (2 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Osteometer Meditech A/S's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Osteometer Meditech A/S's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Osteometer Meditech A/S in the registry?
The most recently registered devices listed for Osteometer Meditech A/S include DTX-200 BONE DENSITOMETER, DTX-100 BONE DENSITOMETER and DTU-ONE ULTRASOUND SCANNER.