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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
SAMSUNG MEDISON CO., LTD.
USS-SAR7E3K/US
In Commercial Distribution

  • 08806167709297 ()


  • General-purpose ultrasound imaging system
No Description
SAMSUNG MEDISON CO., LTD.
USS-SAR5N30/US
In Commercial Distribution

  • 08806167702953 ()


  • General-purpose ultrasound imaging system
No Description
SAMSUNG MEDISON CO., LTD.
USS-MYU6N10/US
In Commercial Distribution

  • 08806167702304 ()


  • General-purpose ultrasound imaging system
No Description
SAMSUNG MEDISON CO., LTD.
USS-AV30F40/US
In Commercial Distribution

  • 08806167700416 ()


  • General-purpose ultrasound imaging system
No Description
SAMSUNG MEDISON CO., LTD.
USS-AV30L40/US
In Commercial Distribution

  • 08806167700409 ()


  • General-purpose ultrasound imaging system
Tablet
BOSTON SCIENTIFIC CORPORATION
M0050320R0
In Commercial Distribution

  • 00191506021931 ()
M0050320R0

  • General-purpose ultrasound imaging system
Tablet
BOSTON SCIENTIFIC CORPORATION
M00503200
In Commercial Distribution

  • 00191506021924 ()
M00503200

  • General-purpose ultrasound imaging system
Motor Drive Unit
BOSTON SCIENTIFIC CORPORATION
M0050330R0
In Commercial Distribution

  • 00191506020941 ()
M0050330R0

  • General-purpose ultrasound imaging system
Motor Drive Unit
BOSTON SCIENTIFIC CORPORATION
M00503300
In Commercial Distribution

  • 00191506020934 ()
M00503300

  • General-purpose ultrasound imaging system
Guidance System
BOSTON SCIENTIFIC CORPORATION
M0050321R0
In Commercial Distribution

  • 00191506020927 ()
M0050321R0

  • General-purpose ultrasound imaging system
Guidance System
BOSTON SCIENTIFIC CORPORATION
M00503210
In Commercial Distribution

  • 00191506020910 ()
M00503210

  • General-purpose ultrasound imaging system
Rail Tray - Dual Track Rail Caddy
ORTHOPEDIATRICS CORP.
01-2200-0105
In Commercial Distribution

  • 00841132178799 ()
01-2200-0105

  • External orthopaedic fixation frame calculation software
Rail Tray - Wire Caddy
ORTHOPEDIATRICS CORP.
01-2200-0104
In Commercial Distribution

  • 00841132178775 ()
01-2200-0104

  • External orthopaedic fixation frame calculation software
Rail Tray - Half Pin Caddy
ORTHOPEDIATRICS CORP.
01-2200-0103
In Commercial Distribution

  • 00841132178720 ()
01-2200-0103

  • External orthopaedic fixation frame calculation software
Rail Tray - Lid
ORTHOPEDIATRICS CORP.
01-2200-0102
In Commercial Distribution

  • 00841132178706 ()
01-2200-0102

  • External orthopaedic fixation frame calculation software
Rail Tray - Base
ORTHOPEDIATRICS CORP.
01-2200-0101
In Commercial Distribution

  • 00841132178683 ()
01-2200-0101

  • External orthopaedic fixation frame calculation 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.
1.1
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
Handheld Ultrasound Scanner T Lite Pro with exchangeables probes
SONOSCANNER
PRO
In Commercial Distribution

  • 03701104600321 ()


  • General-purpose ultrasound imaging system
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