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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 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 1271 SE E
In Commercial Distribution

  • 04547410361346 ()

  • 460x384x15mm


  • Stationary basic diagnostic x-ray system, digital
The FUJIFILM ultrasonic processor SP-900 is intended to be used in combination with FUJIFILM Ultrasonic Probe, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree for observation, recording and to aid in diagnosis during endoscopic evaluation. Modes of Operation: B-mode
FUJIFILM CORPORATION
SP-900
In Commercial Distribution

  • 04547410342741 ()


  • General-purpose ultrasound imaging system
This product is intended to clean the distal end and the forceps elevator mechanism of a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WB1318DE
In Commercial Distribution

  • 14547410341352 ()
  • 04547410341355 ()


  • Surgical instrument/endoscope cleaning utensil, single-use
This product is intended to clean the instrument/suction channel and accessories of a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WB7025DC
In Commercial Distribution

  • 14547410341345 ()
  • 04547410341348 ()


  • Surgical instrument/endoscope cleaning utensil, single-use
This product is intended to clean the suction valve cylinder, air/water valve cylinder, and instrument channel inlet of a FUJIFILM endoscope, as well as the water pump side connector of the J tube in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WB11003DV
In Commercial Distribution

  • 14547410341338 ()
  • 04547410341331 ()


  • Surgical instrument/endoscope cleaning utensil, single-use
The DR-XD 1000 (FDR AQRO) is a digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. The DR-XD 1000 is not intended for mammography applications.
FUJIFILM CORPORATION
DR-XD 1000
In Commercial Distribution

  • 04547410339161 ()


  • Mobile basic diagnostic x-ray system, digital
This device provides illumination to an endoscope and supplies air and water to body cavities via the endoscope, and is intended to provide images captured by the endoscope for endoscopic procedure.
FUJIFILM CORPORATION
BL-7000
In Commercial Distribution

  • 04547410337730 ()


  • Endoscopic light source unit, line-powered
The VP-7000 unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and light source together with monitor, recorder and various peripheral devices. BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examination which can be used to supplement Fujifilm white light endoscopy. BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis.
FUJIFILM CORPORATION
VP-7000
In Commercial Distribution

  • 04547410337419 ()


  • Endoscopic video image processing unit
The FDR-2000BPY provides the function that calculates the three-dimensional coordinates of the image obtained from an exposure and supports the positioning of the needle using the coordinates.
FUJIFILM CORPORATION
POSITIONER KIT BPY-L HA USA E
In Commercial Distribution

  • 04547410336047 ()


  • Stationary mammographic x-ray system, digital
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