Clearance Summary
Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 received FDA 510(k) clearance under submission number K153206, sponsored by Fujifilm Medical System U.S.A., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2016-03-03.
- Submission: K153206
- Applicant / Sponsor: Fujifilm Medical System U.S.A., Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2016-03-03
Classification & Regulation
This clearance is catalogued under FDA product code FDS and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.