Clearance Summary
14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 received FDA 510(k) clearance under submission number K881589, sponsored by Continental 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 1988-07-18.
- Submission: K881589
- Applicant / Sponsor: Continental X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1670
- Decision date: 1988-07-18
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.