Clearance Summary
FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR received FDA 510(k) clearance under submission number K093427, sponsored by Fujifilm Medical System U.S.A., Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2010-01-21.
- Submission: K093427
- Applicant / Sponsor: Fujifilm Medical System U.S.A., Inc.
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2010-01-21
Classification & Regulation
This clearance is catalogued under FDA product code MQB and 21 CFR 892.1680, within the Radiology review panel as a Class II device.