Clearance Summary
FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50 received FDA 510(k) clearance under submission number K061361, 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 2006-08-15.
- Submission: K061361
- Applicant / Sponsor: Faxitron X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2006-08-15
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.