Clearance Summary
AUTIMO 2.5-D AND AUTIMO 3-D received FDA 510(k) clearance under submission number K972016, sponsored by C.L. Mcintosh & Assoc., 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 1997-12-04.
- Submission: K972016
- Applicant / Sponsor: C.L. Mcintosh & Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5710
- Decision date: 1997-12-04
Classification & Regulation
This clearance is catalogued under FDA product code IXI and 21 CFR 892.5710, within the Radiology review panel as a Class II device.