Clearance Summary
SLS-CT received FDA 510(k) clearance under submission number K960985, sponsored by Bio-Imaging Research, 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 1996-10-25.
- Submission: K960985
- Applicant / Sponsor: Bio-Imaging Research, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 1996-10-25
Classification & Regulation
This clearance is catalogued under FDA product code JAK and 21 CFR 892.1750, within the Radiology review panel as a Class II device.