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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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AmCAD UT Detection - 04719875621000

AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.
AMCAD BIOMED CORPORATION
2.2
In Commercial Distribution

  • 04719875621000 ()
  • 14719875621007 ()
UT-0222

  • Ultrasound imaging system application software

N/A - 04961333236763

HL7 INTERFACE OUTBOUND
PENTAX OF AMERICA, INC.
9269
In Commercial Distribution

  • 04961333236763 ()


  • Radiology information system

N/A - 04961333236756

HL7 INTERFACE INBOUND
PENTAX OF AMERICA, INC.
9267
In Commercial Distribution

  • 04961333236756 ()


  • Radiology information system

N/A - 04961333236749

ENDOPORTAL UPGRADE
PENTAX OF AMERICA, INC.
9265
In Commercial Distribution

  • 04961333236749 ()


  • Radiology information system

N/A - 04961333236732

ENDOPORTAL
PENTAX OF AMERICA, INC.
9263
In Commercial Distribution

  • 04961333236732 ()


  • Radiology information system

N/A - 04961333236725

DICOM INTERFACE FOR STROBE
PENTAX OF AMERICA, INC.
9251
In Commercial Distribution

  • 04961333236725 ()


  • Radiology information system

N/A - 04961333236701

DICOM INTERFACE FOR SWALLOWING
PENTAX OF AMERICA, INC.
7251
In Commercial Distribution

  • 04961333236701 ()


  • Radiology information system

KOWA VK-2s - 04987646808947

KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras.
KOWA COMPANY,LTD.
VK28U2E
Not in Commercial Distribution

  • 04987646808947 ()


  • Medical image management system

KOWA VK-2s - 04987646808930

KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras.
KOWA COMPANY,LTD.
VK28UE
Not in Commercial Distribution

  • 04987646808930 ()


  • Medical image management system

KOWA VK-2s - 04987646808923

KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras.
KOWA COMPANY,LTD.
VK28K
Not in Commercial Distribution

  • 04987646808923 ()


  • Medical image management system
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