Fujifilm Medical System U.S.A., Inc.
Fujifilm Medical System U.S.A., Inc. appears in FDA public data with 0 recalls, 71 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on April 25, 2017.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 71
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K163675 | Processor VP-7000, Light Source BL-7000 | April 25, 2017 |
| K153206 | Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 | March 3, 2016 |
| K151474 | Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) | February 18, 2016 |
| K152138 | FDR D-EVO GL Flat Panel Detector System | November 5, 2015 |
| K150221 | EPX-4440HD and EPX-4400HD with FICE | October 1, 2015 |
| K142629 | EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes | May 14, 2015 |
| K142003 | FDR D-EVO II FLAT PANEL DETECTOR SYSTEM | October 21, 2014 |
| K133976 | FUJIFILM ENDOSCOPIC CO2 REGULATOR | September 9, 2014 |
| K132188 | MAMMOGRAPHY VIEWER SMV658 | October 25, 2013 |
| K130542 | SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS | June 14, 2013 |
| K130383 | SYNAPSE 3D CARDIAC TOOLS | April 9, 2013 |
| K122535 | FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H | December 13, 2012 |
| K121499 | FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM | November 20, 2012 |
| K122454 | FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION | November 20, 2012 |
| K121674 | ASPIRE HD PLUS, ASPIRE HD-S | September 21, 2012 |
| K120629 | FDR GO FLEX | August 28, 2012 |
| K120636 | SYNAPSE 3D CARDIAC TOOLS | July 5, 2012 |
| K120648 | SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS | June 14, 2012 |
| K121035 | FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US | June 4, 2012 |
| K120637 | SYNAPSE 3D BRAIN PERFUSION | May 8, 2012 |