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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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No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
VA3
In Commercial Distribution

  • 04068151027013 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11589501
In Commercial Distribution

  • 04068151009477 ()


  • PET system application software
  • SPECT system application software
IB Lab LAMA is a fully-automated radiological image processing software device intended to aid users in the measurement of limb-length discrepancy and quantitative knee alignment parameters on uni- and bilateral AP full leg radiographs of individuals at least 22 years of age. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The software device is intended to be used by healthcare professionals trained in radiology. IB Lab LAMA is not indicated for use on radiographs on which Ankle Arthroplasties and/or Unicompartmental Knee Arthroplasties are present.
IB Lab GmbH
V1.06
In Commercial Distribution

  • 09120105730730 ()


  • X-ray image interpretive software
No Description
Siemens Healthcare GmbH
VA3
In Commercial Distribution

  • 04056869985947 ()


  • Radiology DICOM image processing application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431591
In Commercial Distribution

  • 04056869975559 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431590
In Commercial Distribution

  • 04056869975535 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431567
In Commercial Distribution

  • 04056869975528 ()


  • SPECT system application software
  • PET system application software
No Description
Siemens Healthcare GmbH
11665399
In Commercial Distribution

  • 04056869968278 ()


  • Radiology DICOM image processing application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
VA2
In Commercial Distribution

  • 04056869952574 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431562
In Commercial Distribution

  • 04056869950198 ()


  • SPECT system application software
  • PET system application software
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