Clearance Summary
AXT 150M MANUAL COLLIMATOR (AXT 150M) received FDA 510(k) clearance under submission number K972966, 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 1997-08-21.
- Submission: K972966
- Applicant / Sponsor: Applied X-Ray Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1610
- Decision date: 1997-08-21
Classification & Regulation
This clearance is catalogued under FDA product code IZX and 21 CFR 892.1610, within the Radiology review panel as a Class II device.