Clearance Summary
DTX-100 BONE DENSITOMETER received FDA 510(k) clearance under submission number K963789, sponsored by Osteometer Meditech A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1997-07-14.
- Submission: K963789
- Applicant / Sponsor: Osteometer Meditech A/S
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1170
- Decision date: 1997-07-14
Classification & Regulation
This clearance is catalogued under FDA product code KGI and 21 CFR 892.1170, within the Radiology review panel as a Class II device.