SafeCT-29

GUDID 07290016836202

Medic Vision’s SafeCT-29 provides a vendor-neutral Radiation Dose Check functionality, in accordance with the Dose Check feature that is specified by

MEDIC VISION - IMAGING SOLUTIONS LTD

CT system computer
Primary Device ID07290016836202
NIH Device Record Key113825d1-0d9a-4cde-83cc-558cd1e550c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSafeCT-29
Version Model Number1.0
Company DUNS514775571
Company NameMEDIC VISION - IMAGING SOLUTIONS LTD
Device Count20
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18002788710
Emailsupport@medicvisio.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100729001683639 [Unit of Use]
GS107290016836202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-02-01

Devices Manufactured by MEDIC VISION - IMAGING SOLUTIONS LTD

07290016836004 - SafeCT2018-07-06 The SafeCT is a software package of a PACS server, which is connected to the clinics' Local Area Network (LAN), receives, proces
07290016836202 - SafeCT-292018-07-06Medic Vision’s SafeCT-29 provides a vendor-neutral Radiation Dose Check functionality, in accordance with the Dose Check feature that is specified by
07290016836202 - SafeCT-292018-07-06 Medic Vision’s SafeCT-29 provides a vendor-neutral Radiation Dose Check functionality, in accordance with the Dose Check featu

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