Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1811 SE NON CE E
In Commercial Distribution

  • 04547410478631 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital
The FCR PRIMA T2 (CR-IR 392) is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410472820 ()


  • Computed radiography digital imaging scanner
The FCR PRIMA T2 (CR-IR 392) is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410472813 ()


  • Computed radiography digital imaging scanner
DR-ID 800 (FDR D-EVO Mobile Compo) is digital radiography equipment for mounting on the Mobile Cart and employs an indirect-conversion FPD.
FUJIFILM CORPORATION
DR-ID 800 IU DV3 E
In Commercial Distribution

  • 04547410457704 ()

  • 169×326×230mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1814 SE E
In Commercial Distribution

  • 04547410445503 ()

  • 333x282x15mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1812 SE E
In Commercial Distribution

  • 04547410445480 ()

  • 460x460x15mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1811 SE E
In Commercial Distribution

  • 04547410445466 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 1831SE and DR-ID 1832SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1832 SE E
In Commercial Distribution

  • 04547410445442 ()

  • 460x460x15mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 1831SE and DR-ID 1832SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1831 SE E
In Commercial Distribution

  • 04547410445428 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital
A battery charger for the battery pack.
FUJIFILM CORPORATION
DR1200 SE BATTERY CHARGER B E
In Commercial Distribution

  • 04547410431599 ()


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 1801SE and DR-ID 1802SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1802 SE E
In Commercial Distribution

  • 04547410426915 ()

  • 460x460x15mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 1801SE and DR-ID 1802SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1801 SE E
In Commercial Distribution

  • 04547410426908 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital
The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. It is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1274 SE E
In Commercial Distribution

  • 04547410361377 ()

  • 460x460x15mm


  • Stationary basic diagnostic x-ray system, digital
The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. It is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1273 SE E
In Commercial Distribution

  • 04547410361360 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital
The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. It is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1272 SE E
In Commercial Distribution

  • 04547410361353 ()

  • 460x460x15mm


  • Stationary basic diagnostic x-ray system, digital
The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. It is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1271 SE E
In Commercial Distribution

  • 04547410361346 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital
The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. It is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1275 SE E
In Commercial Distribution

  • 04547410355406 ()

  • 328x268x15mm


  • Stationary basic diagnostic x-ray system, digital
The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
LC PB 35.4X83
In Commercial Distribution

  • 04547410343762 ()

  • 35.4X83 CM


  • Computed radiography digital imaging scanner
The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
LC PB 25.2X58
In Commercial Distribution

  • 04547410343755 ()

  • 25.2X58 CM


  • Computed radiography digital imaging scanner
The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
LC PB 35.4X124.5
In Commercial Distribution

  • 04547410343748 ()

  • 35.4X124.5 CM


  • Computed radiography digital imaging scanner
The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
LC PB 35.4X101.7
In Commercial Distribution

  • 04547410343731 ()

  • 35.4X101.7 CM


  • Computed radiography digital imaging scanner
The Console is a workstation intended to associate digital (for DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving.
FUJIFILM CORPORATION
DR-ID800CL
In Commercial Distribution

  • 04547410333527 ()


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
F898Y200123
In Commercial Distribution

  • 04547410324884 ()


  • Stationary basic diagnostic x-ray system, digital
FDR-2000AWS is a workstation used for Mammography System, intended to associate digital mammography images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving.
FUJIFILM CORPORATION
FDR-2000AWS
In Commercial Distribution

  • 04547410316896 ()


  • Stationary basic diagnostic x-ray system, digital
The CR-IR 363AWS is a CR modality workstation intended to associate FCR images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. And the CR-IR 363AWS is suitable for mammography (especially).
FUJIFILM CORPORATION
CR-IR363AWS
In Commercial Distribution

  • 04547410316889 ()


  • Stationary mammographic x-ray system, digital
The DR-ID 900CL is a workstation intended to associate digital (for CR and/or DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving.
FUJIFILM CORPORATION
DR-ID900CL
In Commercial Distribution

  • 04547410316872 ()


  • Stationary basic diagnostic x-ray system, digital
DR-ID 800 (FDR D-EVO Mobile Compo) is digital radiography equipment for mounting on the Mobile Cart and employs an indirect-conversion FPD.
FUJIFILM CORPORATION
DR-ID 800 IU DV2 E
In Commercial Distribution

  • 04547410308402 ()

  • 169×326×230mm


  • Stationary basic diagnostic x-ray system, digital
A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 900 MC W E
In Commercial Distribution

  • 04547410307061 ()


  • Stationary basic diagnostic x-ray system, digital
A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 900 MC E
In Commercial Distribution

  • 04547410306651 ()


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 911SE is incorporate a CsI indirect panel. Wireless communication mode or wired communication mode can be used.
FUJIFILM CORPORATION
DR-ID 911 SE W E
In Commercial Distribution

  • 04547410306637 ()

  • 464.5 x 516.7 x 18 mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 911SE is incorporate a CsI indirect panel. Wireless communication mode or wired communication mode can be used.
FUJIFILM CORPORATION
DR-ID 911 SE E
In Commercial Distribution

  • 04547410306613 ()

  • 18.2 x 20.3 x 0.70


  • Stationary basic diagnostic x-ray system, digital
Before moving the vehicle, be sure to turn off the FCR PRIMA Tm and insert the dummy cassette.
FUJIFILM CORPORATION
IR DUMMY CASSETTE FOR M MBL E
In Commercial Distribution

  • 04547410297843 ()


  • Computed radiography digital imaging scanner
The FCR CARBON X (CR-IR 357) is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 357
In Commercial Distribution

  • 04547410265903 ()


  • Computed radiography digital imaging scanner
A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 670 MC-WITHOUT SOFT E
In Commercial Distribution

  • 04547410261189 ()


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 613 SE WIRED W E
In Commercial Distribution

  • 04547410257007 ()

  • 328x268x15.7mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 613 SE W E
In Commercial Distribution

  • 04547410256994 ()

  • 328x268x15.7mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 612 SE WIRED W E
In Commercial Distribution

  • 04547410256987 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 612 SE W E
In Commercial Distribution

  • 04547410256970 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 611 SE WIRED W E
In Commercial Distribution

  • 04547410256963 ()

  • 460x384x15.5mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 602 SE WIRED A W E
In Commercial Distribution

  • 04547410256932 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 602 SE A W E
In Commercial Distribution

  • 04547410256925 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 601 SE WIRED A W E
In Commercial Distribution

  • 04547410256871 ()

  • 460x384x14.8mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 601 SE A W E
In Commercial Distribution

  • 04547410256840 ()

  • 460x384x14.8mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 611 SE W E
In Commercial Distribution

  • 04547410256475 ()

  • 460x384x15.5mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 612 SE WIRED E
In Commercial Distribution

  • 04547410245059 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 612 SE E
In Commercial Distribution

  • 04547410245042 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital
The FCR PRIMA T2 (CR-IR 392) is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410239829 ()


  • Computed radiography digital imaging scanner
The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 602 SE WIRED A E
In Commercial Distribution

  • 04547410235975 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 602 SE A E
In Commercial Distribution

  • 04547410235968 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 601 SE WIRED A E
In Commercial Distribution

  • 04547410235951 ()

  • 460x384x14.8mm


  • Stationary basic diagnostic x-ray system, digital
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