Fujifilm Medical Systems U.S.A, Inc.
FDA 510(k) & PMA Approved Devices — 17 products
Total Devices17
Categories11
Latest FDA decision2023-02-13
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| PMA | P160031 | Digital breast tomosynthesis | OTE | 2023-02-13 | View |
| 510(k) | K171291 | FUJIFILM Bronchoscope Model EB-530P | EOQ | 2018-01-19 | View |
| 510(k) | K171207 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M | ODG | 2018-01-11 | View |
| 510(k) | K173132 | ASPIRE Cristalle | MUE | 2017-10-27 | View |
| 510(k) | K171463 | ASPIRE Bellus II | LLZ | 2017-09-29 | View |
| 510(k) | K152257 | Fujifilm Duodenoscope Model ED-530XT | FDT | 2017-07-21 | View |
| 510(k) | K163624 | Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) | MQB | 2017-06-30 | View |
| 510(k) | K162749 | FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR | FDS | 2017-06-15 | View |
| 510(k) | K171096 | Fujifilm Diathermic Slitter (FlushKnife) | KGE | 2017-05-09 | View |
| 510(k) | K170858 | FDR AQRO (DR-XD 1000) | IZL | 2017-04-24 | View |
| 510(k) | K162287 | Synapse 3D Perfusion Analysis | LLZ | 2017-04-06 | View |
| 510(k) | K170451 | FDX Console (DR-ID300CL) Software | LLZ | 2017-03-16 | View |
| 510(k) | K162622 | Fujifilm Endoscope Models EC-600HL and EC-600LS | FDF | 2016-10-18 | View |
| 510(k) | K161186 | Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) | KGE | 2016-06-29 | View |
| 510(k) | K153464 | FDR D-EVO flat Panel Detector System | MQB | 2016-04-08 | View |
| 510(k) | K160196 | Fujifilm Video Colonoscope Model EC-600WL V2 | FDF | 2016-02-23 | View |
| 510(k) | K160108 | Synapse PACS | LLZ | 2016-02-03 | View |
No matching devices.