Clearance Summary
FUJI UM MAMMO SERIES INTENSIFY SCREENS: received FDA 510(k) clearance under submission number K943822, 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 1994-08-22.
- Submission: K943822
- Applicant / Sponsor: Fujifilm Medical System U.S.A., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1960
- Decision date: 1994-08-22
Classification & Regulation
This clearance is catalogued under FDA product code EAM and 21 CFR 892.1960, within the Radiology review panel as a Class I device.