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Device Description : The SafeCT is a software package of a PACS server, which is connected to the cli The SafeCT is a software package of a PACS server, which is connected to the clinics' LocalArea Network (LAN), receives, processes and transfers CT images, using the DICOM protocol.The processing enhances image quality by reduction of the image noise.
Device Class : 2
Duns Number: 514775571
Premarket Exempt : No
Prescription Use : Yes
Device Description : Medic Vision’s SafeCT-29 provides a vendor-neutral Radiation Dose Check function Medic Vision’s SafeCT-29 provides a vendor-neutral Radiation Dose Check functionality, inaccordance with the Dose Check feature that is specified by the NEMA XR-25 Standard. Thedevice is a software and hardware system which includes Computer, dedicated display andcontrols. The SafeCT-29 is interfaced to CT scanners that are not equipped with the DoseCheck function. The device is connected to the CT Console video output via a standard videoconnector. The SafeCT-29 Computer’s internal video splitter captures the CT Console displayvideo, in real time, without affecting neither the CT console itself nor its display. This analogvideo signal is digitized by a video grabber. The SafeCT-29 software analyzes the digital inputvideo using OCR software continuously. The radiation dose information as calculated by thescanner and displayed to the CT operator is extracted and analyzed in real time. The SafeCT-29 captures the video of the CT Console display in real time, without affecting neither the CTconsole itself nor its display and workflow. As specified by NEMA XR-25 Standard, thesafeCT-29 notifies and alerts the CT operators, prior to a scan, if the estimated dose index isabove the predefined values set by the operating group, practice, or organization. SafeCT-29prevents continuing an over-the-limit scan unless dose levels are reconfirmed by the operator,in accordance with NEMA XR-29*.The device records the details of such events, includingthe operator details and decisions. This record is available to the user.
Device Class :
Duns Number: 514775571
Premarket Exempt : No
Prescription Use : Yes
Device Description : The iQMR is a software package, connected to the clinic LAN, that receive and tr The iQMR is a software package, connected to the clinic LAN, that receive and transfer MRI images.The image processing provide enhanced quality by reducing the image noise level.
Device Class : 2
Duns Number: 514775571
Premarket Exempt : No
Prescription Use : No