Clearance Summary
ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS received FDA 510(k) clearance under submission number K133664, sponsored by Ge Medical Systems Ultrasound & Primary Care Diagn. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2014-05-15.
- Submission: K133664
- Applicant / Sponsor: Ge Medical Systems Ultrasound & Primary Care Diagn
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1170
- Decision date: 2014-05-15
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.