Clearance Summary
HEAD-SPINE STABILIZER HSS-1 received FDA 510(k) clearance under submission number K844549, sponsored by Imaging Accessories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1985-03-01.
- Submission: K844549
- Applicant / Sponsor: Imaging Accessories, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1920
- Decision date: 1985-03-01
Classification & Regulation
This clearance is catalogued under FDA product code IWY and 21 CFR 892.1920, within the Radiology review panel as a Class I device.