XRAY COMPUTED TOMOGRAPHY SYSTEM - India CDSCO Medical Device Registration
XRAY COMPUTED TOMOGRAPHY SYSTEM is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000515_a1554f0a72cc6cbcfc544984c4a0cb94_e66bd396e6ea22a49df5d82960d29a6b. This device is marketed under the brand name Hitachi, Ltd., Model : Supria. The license holder is SANRAD MEDICAL SYSTEMS PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Hitachi, Ltd., Model : Supria
License Holder
SANRAD MEDICAL SYSTEMS PRIVATE LIMITEDDevice Class
Approving Authority
CDSCO
Product Information
Intended Use: This system is intended to use at any part of the whole body to get computed tomography images and those images are used for diagnostic purposes. Indication for Use: This system collects volume data of the entire body including the head along the body axis via the axial, helical or dynamic scan. Post processing by the software includes MPR, volume rendering, and analytical processing. Conducting post processing on the images obtained provides separate transverse section images and analytical results. You can also transfer the images to external equipment via the interface complied with DICOM standard. This system enables computed tomography of a patient's entire body, blood vessels, and internal organs since it is capable of producing images regardless of whether or not contrast medium is used. Note that this system is intended to be used to scan infants and includes a protocol for infants.
