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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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Prowess, Inc.
v5.61
Not in Commercial Distribution

  • 00859032007088 ()


  • Radiation therapy software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution

  • 00858012005823 ()
DSC017-03-ROW

  • Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution

  • 00858012005809 ()
DSC017-02-ROW

  • Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution

  • 00858012005793 ()
DSC017-02-US

  • Basic diagnostic x-ray system application software
No Description
Icad, Inc.
DSC018-02
In Commercial Distribution

  • 00850008977114 ()


  • Radiology DICOM image processing application software
E2 Carbon Fiber Fixed Mounting Hardware (set). Fixed mounting hardware option for Matrx E2 Carbon Fiber Backs (16H or less). Requires tools to remove. (Fits 3/4", 7/8" or 1" back cane diameters)
Motion Concepts Inc
CFFX
In Commercial Distribution

  • 07540147001339 ()
CFFX

  • Wheelchair back rest positioner
E2 EasySet Removable Mounting Hardware (pair); includes E2 EasySet Mounting Pin Interface Brackets. Optional mounting hardware for Matrx E2 Backs (18H/20H). Quick-release design.
Motion Concepts Inc
E2EMH
In Commercial Distribution

  • 07540147001193 ()
E2EMH

  • Wheelchair back rest positioner
E2 MiniSet Removable Mounting Hardware (pair); includes E2 MiniSet Mounting Pin Interface Brackets. Optional mounting hardware for Matrx E2 Backs (16H or less). Quick-release design.
Motion Concepts Inc
E2MMH
In Commercial Distribution

  • 07540147001186 ()
E2MMH

  • Wheelchair back rest positioner
Mini Back Hardware Extension Kit (pair). For use with MSMH. Extension kit allows offset height adjustment/installation of the Matrx Mini Back (±2.4" or ±3.6")
Motion Concepts Inc
MINI-EXT
In Commercial Distribution

  • 07540147000608 ()
MINI-EXT

  • Wheelchair back rest positioner
MX2 Removable Heavy-Duty Mounting Hardware (pair) for optional use with the Matrx MX2 Back. (Fits 3/4", 7/8" and 1" back canes). Quick-release design.
Motion Concepts Inc
IMX2QRH-HD
In Commercial Distribution

  • 07540147000295 ()
IMX2QRH-HD

  • Wheelchair back rest positioner
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