HealthCCS

GUDID 07290018016008

ZEBRA MEDICAL VISION LTD

Radiology DICOM image processing application software
Primary Device ID07290018016008
NIH Device Record Keyf0f67cef-965e-4045-9379-6159d3fe948c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealthCCS
Version Model Number3.0.0
Company DUNS600098228
Company NameZEBRA MEDICAL VISION LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290018016008 [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 Number2
Public Version Date2019-10-07
Device Publish Date2019-04-04

Devices Manufactured by ZEBRA MEDICAL VISION LTD

07290018016107 - HealthPPT2022-01-07
07290018016091 - HealthCCSng2021-10-26
07290018016060 - HealthMammo2020-09-29
07290018016084 - HealthVCF2020-09-29
07290018016053 - HealthICH2020-03-16
07290018016046 - HealthCXR2020-01-13
07290018016039 - HealthICH2020-01-09
07290018016022 - HealthICH2019-10-07

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