Clearance Summary
CURIX CAPACITY FILM CENTER received FDA 510(k) clearance under submission number K832603, sponsored by Agfa-Gevaert, 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 1983-09-29.
- Submission: K832603
- Applicant / Sponsor: Agfa-Gevaert, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1900
- Decision date: 1983-09-29
Classification & Regulation
This clearance is catalogued under FDA product code IXW and 21 CFR 892.1900, within the Radiology review panel as a Class II device.