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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
FUJIFILM SONOSITE, INC.
P12822-31
In Commercial Distribution

  • 00841517100087 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System Accessory
FUJIFILM SONOSITE, INC.
P12163-13
In Commercial Distribution

  • 00841517100070 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System Accessory
FUJIFILM SONOSITE, INC.
P12738-31
In Commercial Distribution

  • 00841517100063 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P07678-70
In Commercial Distribution

  • 00841517100056 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System Accessory
FUJIFILM SONOSITE, INC.
P15800-26
In Commercial Distribution

  • 00841517100025 ()
P15800

  • General-purpose ultrasound imaging system
QP-Prostate® CAD is an artificial intelligence-based Computed Aided Detection and Diagnosis (CADe/CADx) image processing software. QP-Prostate® CAD uses AI-based algorithms trained with pathology data to detect suspicious lesions for clinically significant prostate cancer. The device automatically detects and identifies suspected lesions in the prostate gland based on bi-parametric prostate MRI and provides marks over regions of the images that may contain suspected lesions. There are two possible markers that are provided in the different colors suggesting different levels of suspicion of clinically significant prostate cancer (moderate or high suspicion level).
QUIBIM SOCIEDAD LIMITADA.
1.1
In Commercial Distribution

  • 08437021468168 ()


  • MRI image interpretive software
QP-Prostate® CAD is an artificial intelligence-based Computed Aided Detection and Diagnosis (CADe/CADx) image processing software. QP-Prostate® CAD uses AI-based algorithms trained with pathology data to detect suspicious lesions for clinically significant prostate cancer. The device automatically detects and identifies suspected lesions in the prostate gland based on bi-parametric prostate MRI and provides marks over regions of the images that may contain suspected lesions. There are two possible markers that are provided in the different colors suggesting different levels of suspicion of clinically significant prostate cancer (moderate or high suspicion level).
QUIBIM SOCIEDAD LIMITADA.
1.0
In Commercial Distribution

  • 08437021468120 ()


  • MRI image interpretive software
diagnostic ultrasound system
OREON TECHNOLOGIES INC.
4001001
Not in Commercial Distribution

  • 08638750003013 ()


  • General-purpose ultrasound imaging system
No Description
Medical Measurement Systems B.V.
Portascan+
In Commercial Distribution

  • 08717775956051 ()


  • General-purpose ultrasound imaging system
UltraVision-XR Ultrasound System
CADWELL INDUSTRIES, INC.
190315-000
In Commercial Distribution

  • 00840067103487 ()


  • General-purpose ultrasound imaging system
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