FUJIFILM Healthcare Americas Corporation
36 FDA actions
Synapse PACS (7.6.0)
FUJIFILM Healthcare Americas Corporation
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
FUJIFILM Healthcare Americas Corporation
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
FUJIFILM Healthcare Americas Corporation
FUJIFILM Stiffening Wire Device (SW-2000)
FUJIFILM Healthcare Americas Corporation
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynt
FUJIFILM Healthcare Americas Corporation
Synapse PACS (7.5)
FUJIFILM Healthcare Americas Corporation
Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
FUJIFILM Healthcare Americas Corporation
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE)
FUJIFILM Healthcare Americas Corporation
Double Balloon Endoscope EN-840T, Over-tube TS-1214C
FUJIFILM Healthcare Americas Corporation
FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, che
FUJIFILM Healthcare Americas Corporation
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
FUJIFILM Healthcare Americas Corporation
APERTO Lucent MRI System
FUJIFILM Healthcare Americas Corporation
ECHELON Synergy V10.0
FUJIFILM Healthcare Americas Corporation
FCT iSTREAM Phase 1
FUJIFILM Healthcare Americas Corporation
Synapse PACS - Version 7.2.100
FUJIFILM Healthcare Americas Corporation
Synapse PACS - Version 7.1.000
FUJIFILM Healthcare Americas Corporation
Synapse PACS - Version 7.2.000
FUJIFILM Healthcare Americas Corporation
Synapse PACS - Version 7.1.000US
FUJIFILM Healthcare Americas Corporation
Synapse PACS - Version 7.3.000
FUJIFILM Healthcare Americas Corporation
Synapse PACS - Version 7.2.200
FUJIFILM Healthcare Americas Corporation
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the proces
FUJIFILM Healthcare Americas Corporation
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
FUJIFILM Healthcare Americas Corporation
FUJIFILM Endoscope Model EB-710XT
FUJIFILM Healthcare Americas Corporation
Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
FUJIFILM Healthcare Americas Corporation
ARIETTA x10
FUJIFILM Healthcare Americas Corporation
Scenaria View 4.2
FUJIFILM Healthcare Americas Corporation
Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)
FUJIFILM Healthcare Americas Corporation
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
FUJIFILM Healthcare Americas Corporation
FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for g
FUJIFILM Healthcare Americas Corporation
Surpria 64: Software Version V3.11, V3.22
FUJIFILM Healthcare Americas Corporation
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
FUJIFILM Healthcare Americas Corporation
Surpria: Software Version V3.11, V3.22
FUJIFILM Healthcare Americas Corporation
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
FujiFilm Healthcare Americas Corporation
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
FujiFilm Healthcare Americas Corporation
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
FujiFilm Healthcare Americas Corporation
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
FujiFilm Healthcare Americas Corporation