510(k) · Cleared
ClearedIQ-UIP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imbio, Inc. · QWO Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
Cleared on Dec 19, 2024 as substantially equivalent to DEN220040 (Imvaria, Inc., 2024) after a 121-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Dec 19, 2024
- Review
- 121 days
- Class
- Class II
- Product code
- QWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN220040 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN220040 FibresolveImvaria, Inc. · 2024
- This deviceK242467 IQ-UIPImbio, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN220040 | Fibresolve | Imvaria, Inc. | 2024 | — |
| 0 (this device) | K242467 | IQ-UIP | Imbio, Inc. | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QWO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QWO device
- #1 K252041 Fibresolve (with PCCP)score 10.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN220040 | FibresolveSummary page 6…P Legally Marketed Device To Which The Device Is Substantially Equivalent The IQ-UIP Software is substantially equivalent to the Imvaria, Inc Fibresolve authorized under DEN220040. Description of the Device Imbio IQ-UIP is a computer-aided software indicated for use in notifying specialists associated with… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN220040.
How does its category compare?
All QWO devicesQWO Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QWO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QWO
Too few QWO 510(k)s in any year since 2007 to give a median.
Recalls per year · QWO
No recall names QWO since 2007.
Adverse event reports per year · QWO
No MAUDE report names QWO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (207 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K242467 · printed Nov 3, 2026
Cite this page
510(k) Report. “K242467: IQ-UIP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K242467
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026