Lunit INSIGHT MMG

GUDID 08800076000056

Lunit Inc.

X-ray image interpretive software
Primary Device ID08800076000056
NIH Device Record Key8921a5be-5a44-4ef4-ad46-8e4106a6b90f
Commercial Distribution StatusIn Commercial Distribution
Brand NameLunit INSIGHT MMG
Version Model Number1.1.6.5
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
GS108800076000056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

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

Devices Manufactured by Lunit Inc.

08800076000162 - Lunit INSIGHT DBT2024-04-17
08800076000179 - Lunit INSIGHT CXR Triage2024-04-17 Lunit INSIGHT CXR Triage - Windows version
08800076000148 - Lunit INSIGHT DBT2023-12-11
08800076000056 - Lunit INSIGHT MMG2022-05-06
08800076000056 - Lunit INSIGHT MMG2022-05-06
08800076000124 - Lunit INSIGHT CXR Triage2022-05-06

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