HealthCXR

GUDID 07290018016046

ZEBRA MEDICAL VISION LTD

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software
Primary Device ID07290018016046
NIH Device Record Key43d2182c-9124-4b0e-bc82-2e796f61aa61
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealthCXR
Version Model Number1.0.0
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290018016046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QFMRadiological Computer-Assisted Prioritization Software For Lesions

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-13
Device Publish Date2020-01-03

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
07290018016046 - HealthCXR2020-01-13
07290018016039 - HealthICH2020-01-09
07290018016022 - HealthICH2019-10-07

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