Fujifilm Medical Systems U.S.A, Inc.
Fujifilm Medical Systems U.S.A, Inc. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2018, with 37 FDA device recalls on record.
Top product codes for Fujifilm Medical Systems U.S.A, Inc.
FDA recalls by Fujifilm Medical Systems U.S.A, Inc.
10 most recent of 37- Z-1775-2021 — Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
- Z-1348-2021 — Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
- Z-1412-2021 — ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
- Z-0932-2021 — Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma.
- Z-0918-2021 — FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
- Z-0282-2021 — Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
- Z-0878-2021 — Synapse PACS Software Versions 5.1 and higher
- Z-2471-2020 — Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
- Z-2441-2019 — Fujifilm FDR Go Plus mobile X-ray system
- Z-1040-2019 — Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)>
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Fujifilm Medical Systems U.S.A, Inc.
- K171291 — FUJIFILM Bronchoscope Model EB-530P
- K171207 — FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
- K173132 — ASPIRE Cristalle
- K171463 — ASPIRE Bellus II
- K152257 — Fujifilm Duodenoscope Model ED-530XT
- K163624 — Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)
- K162749 — FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
- K171096 — Fujifilm Diathermic Slitter (FlushKnife)
- K170858 — FDR AQRO (DR-XD 1000)
- K162287 — Synapse 3D Perfusion Analysis
- K170451 — FDX Console (DR-ID300CL) Software
- K162622 — Fujifilm Endoscope Models EC-600HL and EC-600LS
- K161186 — Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)
- K153464 — FDR D-EVO flat Panel Detector System
- K160196 — Fujifilm Video Colonoscope Model EC-600WL V2
- K160108 — Synapse PACS
- K153483 — Balloon controller PB-30
- K143556 — Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
- K151859 — Synapse Cardiovascular
- K143732 — FUJIFILM Endoscope Models EC-600HL and EC-600LS
- K141765 — FDR D-EVO FLAT PANEL DETECTOR SYSTEM
- K140149 — EPX-4440HD DIGITAL VIDEO PROCESSOR
- K133972 — ASPIRE CRISTALLE
- K132210 — FUJIFILM 600 SERIES ENDOSCOPES
- K132509 — FDR D-EVO FLAT PANEL DETECTOR SYSTEM
- K123566 — SYNAPSE 3D COLON ANALYSIS
- K120679 — SYNAPSE 3D NODULE ANALYSIS
- K120361 — SYNAPSE 3D BASE TOOLS
- K110729 — ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
- K103596 — WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR
- K103720 — SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
- K103465 — SYNAPSE 3D CARDIAC TOOLS
- K100762 — FLAT PANEL DETECTOR, MODEL FDR D-EVO
- K081308 — FUJIFILM FCR VIEW, MODEL CR-VW674
- K080945 — FCR GO PORTABLE DIGITAL X-RAY SYSTEM
- K073650 — FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371
- K070920 — FUJI IP CASSETTE TYPE PC
- K061672 — SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS
- K051553 — FUJI SYNAPSE WORKSTATION SOFTWARE
Data sourced from openFDA. This site is unofficial and independent of the FDA.