SmartChest

GUDID 03770024774016

MILVUE

X-ray image interpretive software
Primary Device ID03770024774016
NIH Device Record Key0e1182ea-c029-427c-ba8e-c1e6536d580f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartChest
Version Model NumberV2.x.x
Company DUNS271298427
Company NameMILVUE
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
GS103770024774016 [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 Date2025-04-08
Device Publish Date2025-03-31

Devices Manufactured by MILVUE

03770024774016 - SmartChest2025-04-08
03770024774016 - SmartChest2025-04-08
03770024774047 - TechCare Trauma2025-04-08

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