Radiology · 510(k) · 2024
IQ-UIP
Imbio, Inc.. Cleared by FDA on 19 December 2024 under submission K242467, product code QWO (radiology software for referral of findings related to fibrotic lung disease.). What FDA's record says, in FDA's words.
Device record · K242467
- Device. IQ-UIPDEVICE
- Company. Imbio, Inc.COMPANY
- Decision. 19 December 2024, 510(k), substantially equivalent (traditional review); received 20 August 2024DECISION
- Panel. RadiologyPANEL
- Product code. QWO, Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.CODE
- Regulation. 21 CFR 892.2085, Class IIREG
- Source. FDA database entry · decision document (13 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Imbio IQ-UIP is a computer-aided software indicated for use in passively 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. Imbio IQ-UIP uses an artificial intelligence algorithm to analyze images and identify positive findings on a worklist application separate from and in parallel to the standard of care radiological image interpretation. Identification of positive findings include summary reports with a clinical guideline reference for the definition of UIP pattern that are meant for informational purposes only. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of Imbio IQ-UIP are used to notify specialists at an ILD center of radiological findings that may be consistent with UIP . These specialists are qualified clinicians experienced in evaluating chest CTs for ILD. Input images originate from within the same hospital network associated with the ILD center. The results of Imbio IQ-UIP are intended to be used in conjunction with additional patient information and based on the user's professional judgment, to assist with the review of medical images. Notified clinicians are responsible for viewing full image series and making final clinical determinations.
The product code's definition, from FDA's classification record. Radiology software for referral of findings related to fibrotic lung disease is a prescription image processing device that analyzes computed tomography images to suggest the presence of disease or of an imaging finding suggestive of disease. The output of this device is intended to be used as adjunctive information as part of a referral pathway in the overall diagnostic assessment process.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QWO. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QWO, in Radiology, from Imbio, Inc., or cleared in 2024. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.