IQ-UIP

Primary DI
00850894007919
Brand
IQ-UIP
Company
4DMEDICAL LIMITED
Model
2.0.0
Device description
Imbio IQ-UIP is a computer-aided software indicated for use in notifying specialists associated with Interstitial Lung Disease (ILD) Centers of radiological findings suggestive of radiological Usual Interstitial Pneumonia (UIP) in non-contrast, chest CT scans of adults.
Published
2026-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00850894007919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850894007919008508940079198508940079190850894007919

GMDN Terms#

Term, Definition table
TermDefinition
X-ray image interpretive softwareAn interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].

Regulatory Flags#

DUNS number
747517097
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
G86321ScreenDxIMVARIA INC.QWO2026-04-23
G86331FibresolveIMVARIA INC.QWO2026-04-23
G86311FibresolveIMVARIA INC.QWO2026-04-22