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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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Quantib AI Node - 08719689791193

No Description
Quantib B.V.
2.5
In Commercial Distribution

  • 08719689791193 ()


  • Radiology DICOM image processing application software

Quantib AI Node - 08719689791162

No Description
Quantib B.V.
2.4
In Commercial Distribution

  • 08719689791162 ()


  • Radiology DICOM image processing application software

Quantib AI Node - 08719689791124

No Description
Quantib B.V.
2.3
In Commercial Distribution

  • 08719689791124 ()


  • Radiology DICOM image processing application software

Quantib AI Node - 08719689791100

No Description
Quantib B.V.
2.2
In Commercial Distribution

  • 08719689791100 ()


  • Radiology DICOM image processing application software

Quantib AI Node - 08719689791049

No Description
Quantib B.V.
2.0
In Commercial Distribution

  • 08719689791049 ()


  • Radiology DICOM image processing application software

Sono dot AI - 08800076600157

No Description
FCU
SC1
In Commercial Distribution

  • 08800076600157 ()


  • Hand-held ultrasound imaging system, body-surface

GENIUS AI DETECTION - 15420045512474

Genius AI® is a computer-aided detection and diagnosis (CADe/CADx) software device intended to be used with compatible digital breast tomosynthsis (DBT) systems to identify and mark regions of interest including soft tissue densities (masses, architectural distortions, and assymetries) and calcifications in DBT exams from compatible DBT systems and provide confidence scores that offer assessment for Certainty of Findings and a Case Score.
Hologic, Inc.
GENIUS AI DETECTION SOFTWARE
In Commercial Distribution

  • 15420045512474 ()
ASY-15431

  • Stationary mammographic x-ray system, digital

Quantum - 05060434424051

Quantum Smart Occluder - Right Hand
SPECTRUM MEDICAL LIMITED
QSOR
In Commercial Distribution

  • 05060434424051 ()
51-000074-02

  • Cardiopulmonary bypass system air bubble/fluid level detector

Quantum - 05060434424044

Quantum Smart Occluder - Left Hand
SPECTRUM MEDICAL LIMITED
QSOL
In Commercial Distribution

  • 05060434424044 ()
51-000022-02

  • Cardiopulmonary bypass system air bubble/fluid level detector

Quantum - 05060434423986

Quantum Reservoir Level Sensor Cradle - Curved Taper
SPECTRUM MEDICAL LIMITED
LSC_HRCT
In Commercial Distribution

  • 25060434423980 ()
  • 05060434423986 ()
LSC_HRCT

  • Sensor holder, single-use
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