Device
Imbio IQ-UIP is a computer-aided software indicated for use in notifying specialists
Manufacturer
4DMEDICAL LIMITED
4DMEDICAL LIMITED
Model: 2.0.0
DI: 00850894007919
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-10
Current Version: 2026-05-18
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1190c0e2-ef07-4e6f-a135-e708f000ccf3
Distribution Status:
In Commercial Distribution
DUNS Number:
747517097
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850894007919
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 63386
Name: X-ray image interpretive software
Definition:
An 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].
FDA Product Codes
QWO
Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
Premarket Submissions
Submission Number:
K242467
Supplement Number:
000