Clearance Summary
DUAL-PHOTON TOTAL BODY BONE MINERAL ANA received FDA 510(k) clearance under submission number K810140, sponsored by Lunar Radiation 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 1981-02-12.
- Submission: K810140
- Applicant / Sponsor: Lunar Radiation Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1170
- Decision date: 1981-02-12
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.