Clearance Summary
FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20 received FDA 510(k) clearance under submission number K072557, sponsored by Faxitron X-Ray 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 2007-10-30.
- Submission: K072557
- Applicant / Sponsor: Faxitron X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2007-10-30
Classification & Regulation
This clearance is catalogued under FDA product code MWP and 21 CFR 892.1680, within the Radiology review panel as a Class II device.