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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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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
LOGIQ Fortis R3 to R4 Upgrade with Hardware
GE Ultrasound Korea Ltd.
Fortis R3 to R4 HW Upgrade
In Commercial Distribution

  • 00195278835802 ()
5946726

  • General-purpose ultrasound imaging system
LOGIQ E10s R2/R3 to R4 SW Upgrade
GE Ultrasound Korea Ltd.
E10s R2R3 to R4 SW Upgade
In Commercial Distribution

  • 00195278835796 ()
5946721

  • General-purpose ultrasound imaging system
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