CDM Insights

GUDID 05070003179800

OXFORD BRAIN DIAGNOSTICS LTD

Radiology DICOM image processing application software
Primary Device ID05070003179800
NIH Device Record Keyf15c0330-17d1-49e2-b467-60cfb5601112
Commercial Distribution StatusIn Commercial Distribution
Brand NameCDM Insights
Version Model Number1.53
Company DUNS224552649
Company NameOXFORD BRAIN DIAGNOSTICS 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 Batchtrue
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
GS105070003179800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIHAutomated Radiological Image Processing Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-03
Device Publish Date2026-01-26

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