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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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PHILIPS HEARSUITE 2020.1
Sbo Hearing A/S
214709
In Commercial Distribution

  • 05714464003600 ()


  • Audiometric/hearing device software
HEARSUITE 2019.2
Sbo Hearing A/S
204550
In Commercial Distribution

  • 05714464002849 ()


  • Audiometric/hearing device software
HEARSUITE 2019.1
Sbo Hearing A/S
196006
In Commercial Distribution

  • 05714464000029 ()


  • Audiometric/hearing device software
The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review. The Cedars-Sinai Cardiac Suite operates on camera independent reconstructed SPECT and/or PET image files. Cedars-Sinai Cardiac Suite will be marketed as a comprehensive application suite that includes QGS (Quantitative Gated SPECT), QPS (Quantitative Perfusion SPECT) and CSImport applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies.
CEDARS-SINAI MEDICAL CENTER
2017
In Commercial Distribution

  • 00864687000247 ()


  • Image segmentation application software
The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review. The Cedars-Sinai Cardiac Suite operates on camera independent reconstructed SPECT and/or PET image files. Cedars-Sinai Cardiac Suite will be marketed as a comprehensive application suite that includes QGS (Quantitative Gated SPECT), QPS (Quantitative Perfusion SPECT) and CSImport applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies.
CEDARS-SINAI MEDICAL CENTER
2015
In Commercial Distribution



  • Image segmentation application software
The Cedars-Sinai Cardiac Suite is a stand-alone software solution for Cardiac SPECT and PET imaging processing and review. The Cedars-Sinai Cardiac Suite operates on camera independent reconstructed SPECT and/or PET image files. Cedars-Sinai Cardiac Suite will be marketed as a comprehensive application suite that includes QGS (Quantitative Gated SPECT), QPS (Quantitative Perfusion SPECT) and CSImport applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA), Motion Correction (MOCO) and QPET. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies.
CEDARS-SINAI MEDICAL CENTER
2015
In Commercial Distribution

  • 00864687000209 ()


  • Image segmentation application software
Optum Homecare Portal W/BP
OPTUMHEALTH CARE SOLUTIONS, INC.
UA651BLE
Not in Commercial Distribution

  • 00862492000346 ()
AAA-00007

  • Self-care monitoring/reporting software
Optum Home BP I-Apollo
OPTUMHEALTH CARE SOLUTIONS, INC.
UA651BLE
Not in Commercial Distribution

  • 00862492000339 ()
AAA-80013

  • Self-care monitoring/reporting software
Optum Home Scale I-ICUE
OPTUMHEALTH CARE SOLUTIONS, INC.
EM724BT
Not in Commercial Distribution

  • 00862492000322 ()
AAA-85009

  • Self-care monitoring/reporting software
Optum Home Scale I-Apollo
OPTUMHEALTH CARE SOLUTIONS, INC.
EM724BT
Not in Commercial Distribution

  • 00862492000315 ()
AAA-80012

  • Self-care monitoring/reporting software
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