Clearance Summary
SECTRA OSTEOPOROSIS PACKAGE received FDA 510(k) clearance under submission number K021527, sponsored by Sectra-Imtec AB. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2002-06-07.
- Submission: K021527
- Applicant / Sponsor: Sectra-Imtec AB
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1170
- Decision date: 2002-06-07
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.