Clearance Summary
FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE received FDA 510(k) clearance under submission number K923990, sponsored by Fujifilm Medical System U.S.A., 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 1992-12-17.
- Submission: K923990
- Applicant / Sponsor: Fujifilm Medical System U.S.A., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1630
- Decision date: 1992-12-17
Classification & Regulation
This clearance is catalogued under FDA product code IXK and 21 CFR 892.1630, within the Radiology review panel as a Class II device.