Clearance Summary
SENTINEL, MODEL SP-001 received FDA 510(k) clearance under submission number K082582, sponsored by C-Rad Positioning AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2009-03-30.
- Submission: K082582
- Applicant / Sponsor: C-Rad Positioning AB
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2009-03-30
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.