Clearance Summary
AII-PRO 100 PLUS AND ALL-PRO 200 received FDA 510(k) clearance under submission number K991435, 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 1999-05-20.
- Submission: K991435
- Applicant / Sponsor: All-Pro Imaging Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1900
- Decision date: 1999-05-20
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.