Home GUDID 19356870000076 IQ-UIP
Primary DI 19356870000076
Brand IQ-UIP
Company 4DMEDICAL LIMITED
Model 2.1.2
Device description 4DMedical’s IQ UIP software device uses a locked artificial intelligence algorithm to automatically analyze a qualifying chest computed tomography (CT) scan. The device performs image classification to identify if a chest CT scan contains findings suspicious for the radiological usual interstitial pneumonia (UIP) pattern and generates a summary output to report positive findings in parallel to and separate from the standard of care radiological image interpretation.
Published 2026-10-13
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name QWO Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QWO Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 19356870000076 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 19356870000076 19356870000076
Regulatory Flags# DUNS number 747517097 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex true No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850894007919 IQ-UIP 4DMEDICAL LIMITED QWO 2026-05-10 G86321 ScreenDx IMVARIA INC. QWO 2026-04-23 G86331 Fibresolve IMVARIA INC. QWO 2026-04-23 G86311 Fibresolve IMVARIA INC. QWO 2026-04-22