Clearance Summary
A.X.T. SPOTFILM DEVICE received FDA 510(k) clearance under submission number K882492, sponsored by Applied X-Ray Technologies, 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 1988-07-21.
- Submission: K882492
- Applicant / Sponsor: Applied X-Ray Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1670
- Decision date: 1988-07-21
Classification & Regulation
This clearance is catalogued under FDA product code IXL and 21 CFR 892.1670, within the Radiology review panel as a Class II device.