Fujifilm Medical Systems U.S.A., Inc.
FDA Regulatory Profile
Fujifilm Medical Systems U.S.A., Inc. appears in FDA public data with 37 recalls, 39 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1775-2021, Class II) was initiated on April 30, 2021. Its most recent 510(k) clearance was granted on January 19, 2018.
Summary
- Total Recalls
- 37
- 510(k) Clearances
- 39
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1775-2021 | Class II | Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular i | April 30, 2021 |
| Z-1348-2021 | Class II | Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web base | March 2, 2021 |
| Z-1412-2021 | Class II | ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit | February 18, 2021 |
| Z-0932-2021 | Class III | Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LD | December 22, 2020 |
| Z-0918-2021 | Class II | FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web | December 11, 2020 |
| Z-0878-2021 | Class II | Synapse PACS Software Versions 5.1 and higher | September 11, 2020 |
| Z-0282-2021 | Class II | Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on | September 11, 2020 |
| Z-2471-2020 | Class II | Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synap | May 22, 2020 |
| Z-2441-2019 | Class II | Fujifilm FDR Go Plus mobile X-ray system | July 19, 2019 |
| Z-1040-2019 | Class II | Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to | January 15, 2019 |
| Z-0659-2018 | Class II | Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), gen | August 4, 2017 |
| Z-0661-2018 | Class II | ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FD | August 4, 2017 |
| Z-0660-2018 | Class II | Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire H | August 4, 2017 |
| Z-0662-2018 | Class II | Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiograp | August 4, 2017 |
| Z-3225-2017 | Class II | FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digesti | July 21, 2017 |
| Z-0386-2018 | Class II | ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Asp | July 14, 2017 |
| Z-0385-2018 | Class II | Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also | July 14, 2017 |
| Z-0232-2018 | Class II | FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing N | June 15, 2017 |
| Z-2706-2017 | Class II | Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide u | February 17, 2017 |
| Z-0073-2017 | Class II | Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Med | September 15, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K171291 | FUJIFILM Bronchoscope Model EB-530P | January 19, 2018 |
| K171207 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M | January 11, 2018 |
| K173132 | ASPIRE Cristalle | October 27, 2017 |
| K171463 | ASPIRE Bellus II | September 29, 2017 |
| K152257 | Fujifilm Duodenoscope Model ED-530XT | July 21, 2017 |
| K163624 | Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) | June 30, 2017 |
| K162749 | FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR | June 15, 2017 |
| K171096 | Fujifilm Diathermic Slitter (FlushKnife) | May 9, 2017 |
| K170858 | FDR AQRO (DR-XD 1000) | April 24, 2017 |
| K162287 | Synapse 3D Perfusion Analysis | April 6, 2017 |
| K170451 | FDX Console (DR-ID300CL) Software | March 16, 2017 |
| K162622 | Fujifilm Endoscope Models EC-600HL and EC-600LS | October 18, 2016 |
| K161186 | Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) | June 29, 2016 |
| K153464 | FDR D-EVO flat Panel Detector System | April 8, 2016 |
| K160196 | Fujifilm Video Colonoscope Model EC-600WL V2 | February 23, 2016 |
| K160108 | Synapse PACS | February 3, 2016 |
| K153483 | Balloon controller PB-30 | December 15, 2015 |
| K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T | August 20, 2015 |
| K151859 | Synapse Cardiovascular | August 12, 2015 |
| K143732 | FUJIFILM Endoscope Models EC-600HL and EC-600LS | July 6, 2015 |