Clearance Summary
ALL-PRO 100 received FDA 510(k) clearance under submission number K911291, sponsored by All-Pro Imaging Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1991-07-03.
- Submission: K911291
- Applicant / Sponsor: All-Pro Imaging Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1900
- Decision date: 1991-07-03
Classification & Regulation
This clearance is catalogued under FDA product code IXW and 21 CFR 892.1900, within the Radiology review panel as a Class II device.