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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 DynaLOC Breast Interventional Planning software module supports the use of MR interventional breast coils and localization devices to perform MR-guided breast interventional procedures. Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion, relative to the interventional device. The accuracy of DynaLOC software depends on the resolution of the acquired dataset. If the sum of the slice thicknesses for marker and target series does not exceed 5 mm, the 3-dimensional accuracy is 5 mm. Otherwise it is equal to the sum of two slice thicknesses for marker and target series. The accuracy can be negatively affected by any of the following: • Significant patient movement after the breast is securely immobilized in the biopsy device • Significant displacement of tissue during needle penetration • Image distortion in the MR dataset.
Icad, Inc.
3.5
In Commercial Distribution

  • 00858012005779 ()
D75014-05, D57015-05

  • Radiological PACS software
No Description
Elekta Solutions AB
3.0.2
In Commercial Distribution

  • 00858164002381 ()


  • Radiation therapy software
No Description
Elekta Solutions AB
Monaco
In Commercial Distribution

  • 00858164002275 ()


  • Radiation therapy software
No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002268 ()


  • Radiation therapy software
No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002244 ()


  • Radiation therapy software
No Description
ELEKTA, INC.
ERGO Localizer
Not in Commercial Distribution

  • 00858164002213 ()


  • Radiation therapy software
No Description
ELEKTA, INC.
ERGO++
Not in Commercial Distribution

  • 00858164002206 ()


  • Radiation therapy software
No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002190 ()


  • Radiation therapy software
No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002183 ()


  • Radiation therapy software
No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002169 ()


  • Radiation therapy software
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