Lunit INSIGHT CXR Triage

GUDID 08800076000124

Lunit Inc.

X-ray image interpretive software
Primary Device ID08800076000124
NIH Device Record Keybb1af085-b6e5-434a-87c8-fb3b32af9c49
Commercial Distribution StatusIn Commercial Distribution
Brand NameLunit INSIGHT CXR Triage
Version Model Number1.0.0.0
Company DUNS690102406
Company NameLunit Inc.
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 Numbertrue
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
GS108800076000124 [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 Date2022-05-06
Device Publish Date2022-04-28

On-Brand Devices [Lunit INSIGHT CXR Triage]

088000760001241.0.0.0
08800076000179Lunit INSIGHT CXR Triage - Windows version

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