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
CodeName
QWORadiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWORadiology Software For Referral Of Findings Related To Fibrotic Lung Disease.Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242467000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242467000IQ-UIPImbio, Inc.2024-12-19QWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19356870000076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1935687000007619356870000076

GMDN Terms#

Term, Definition table
TermDefinition
Chest/vascular CT/MRI clinical assessment support softwareA software program intended to display, analyse/process, and possibly acquire computed tomography (CT) and/or magnetic resonance imaging (MRI) data of the chest anatomy (e.g., lungs, heart) and/or vascular system, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage) of a pulmonary, cardiac and/or vascular condition (e.g., pulmonary embolism, coronary artery disease, abdominal aortic aneurysm, cancer). It is not dedicated to treatment planning, neurovascular or orthopaedic image analysis, and does not incorporate adaptive/dynamic machine learning (ML) models.

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
19356870000045CAC3.1.x2026-10-13
19356870000069PHA4.0.12026-10-13
19356870000090LDA5.2.x2026-10-13
00850894007919IQ-UIP2.0.02026-05-10
19356870000038CT:VQ2.2.02026-01-28
01935687000038CT:VQ2.2.02025-12-08
19356870000021CT LVAS1.x2024-06-20
19356870000014XV Lung Ventilation Analysis SoftwareXV LVAS2021-01-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850894007919IQ-UIP4DMEDICAL LIMITEDQWO2026-05-10
G86321ScreenDxIMVARIA INC.QWO2026-04-23
G86331FibresolveIMVARIA INC.QWO2026-04-23
G86311FibresolveIMVARIA INC.QWO2026-04-22