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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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NA - EPTWS0800280

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
TanSoft software
In Commercial Distribution

  • EPTWS0800280 ()
S080028

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NovoTAL Software for Array Mapping - 07290107981729

No Description
Novocure GmbH
NovoTAL Software
In Commercial Distribution

  • 07290107981729 ()
90094

  • Alternating electric field antimitotic cancer treatment system generator

NovoTAL Software for Array Mapping - 07290107981576

No Description
Novocure GmbH
NovoTAL Software
Not in Commercial Distribution

  • 07290107981576 ()
90094

  • Alternating electric field antimitotic cancer treatment system generator

NovoTAL Software for Array Mapping - 07290107980715

No Description
Novocure GmbH
NovoTAL Software
Not in Commercial Distribution

  • 07290107980715 ()
90094

  • Alternating electric field antimitotic cancer treatment system generator

Duet™ - 07290107653053

No Description
BIO-VIEW LTD
Solo Software
In Commercial Distribution

  • 07290107653053 ()


  • Fluorescence light microscope

3Dimensions - 15420045507296

Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Hologic, Inc.
3DIMENSIONS SOFTWARE
In Commercial Distribution

  • 15420045507296 ()
SW-04883

  • Stationary mammographic x-ray system, digital

Affirm Prone Biopsy System - 15420045504721

No Description
Hologic, Inc.
System Software
In Commercial Distribution

  • 15420045504721 ()


  • Mammographic stereotactic biopsy system

Selenia Dimensions 3D System - 15420045500013

Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Hologic, Inc.
3D software
In Commercial Distribution

  • 15420045500013 ()
SW-01648

  • Stationary mammographic x-ray system, digital

I-View - 15420045512658

No Description
Hologic, Inc.
I-View Software
In Commercial Distribution

  • 15420045512658 ()
SW-03078

  • Stationary mammographic x-ray system, digital

3DQuorum - 15420045512313

3DQuorum® is an image processing software application for post-processing tomosynthesis data captured on a Hologic tomosynthesis imaging system, into a combined 3D image.
Hologic, Inc.
3DQUORUM SOFTWARE
In Commercial Distribution

  • 15420045512313 ()
SW-05673

  • Stationary mammographic x-ray system, digital
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