Clearance Summary
AXT 1400 SPOTFILM DEVICE received FDA 510(k) clearance under submission number K942367, 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 1994-06-06.
- Submission: K942367
- 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: 1994-06-06
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.