510(k) K163675
K163675 is an FDA 510(k) premarket notification submitted by Fujifilm Medical System U.S.A., Inc. for the device "Processor VP-7000, Light Source BL-7000". The FDA issued a decision of Substantially Equivalent on April 25, 2017. The device falls under product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Fujifilm Medical System U.S.A., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2017
- Date Received
- December 27, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.