Clearance Summary
ORCA-DX BONE DENSITOMETER received FDA 510(k) clearance under submission number K983724, sponsored by Lunar Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1998-12-08.
- Submission: K983724
- Applicant / Sponsor: Lunar Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1170
- Decision date: 1998-12-08
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.