Clearance Summary
GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION received FDA 510(k) clearance under submission number K082317, sponsored by General Electric Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2008-09-26.
- Submission: K082317
- Applicant / Sponsor: General Electric Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1170
- Decision date: 2008-09-26
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.