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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.
P20680-40R
In Commercial Distribution

  • 00841517106652 ()
P20680

  • General-purpose ultrasound imaging system
No Description
FUJIFILM SONOSITE, INC.
P17000-40C
In Commercial Distribution

  • 00841517106645 ()
P17000

  • General-purpose ultrasound imaging system
No Description
FUJIFILM SONOSITE, INC.
P17000-40R
In Commercial Distribution

  • 00841517106638 ()
P17000

  • General-purpose ultrasound imaging system
No Description
FUJIFILM SONOSITE, INC.
P24550-40
In Commercial Distribution

  • 00841517106621 ()
P24550

  • General-purpose ultrasound imaging system
No Description
FUJIFILM SONOSITE, INC.
P20680-40
In Commercial Distribution

  • 00841517106614 ()
P20680

  • General-purpose ultrasound imaging system
No Description
FUJIFILM SONOSITE, INC.
P17000-40
In Commercial Distribution

  • 00841517106607 ()
P17000

  • General-purpose ultrasound imaging system
Loaner, Sonosite PX
FUJIFILM SONOSITE, INC.
P27925-01
In Commercial Distribution

  • 00841517106478 ()
P27925

  • 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
UltraVision-XR Ultrasound System
CADWELL INDUSTRIES, INC.
190315-000
In Commercial Distribution

  • 00840067103487 ()


  • General-purpose ultrasound imaging system
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