De Novo · Granted
GrantedFibresolve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imvaria, Inc. · QWO Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
Granted on Jan 12, 2024 as a new device type through De Novo after a 562-day review. 3 later devices descend from it.
- Decided
- Jan 12, 2024
- Review
- 562 days
- Class
- Class II
- Product code
- QWO
- Recalls
- None
3 later devices descend from it, 3 citing it directly.
- This deviceDEN220040 FibresolveImvaria, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK252041 Fibresolve (with PCCP)Imvaria, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK241891 ScreenDxImvaria, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK242467 IQ-UIPImbio, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN220040 | Fibresolve | Imvaria, Inc. | 2024 | — |
| +1 | K252041 | Fibresolve (with PCCP) | Imvaria, Inc. | 2025 | — |
| +1 | K241891 | ScreenDx | Imvaria, Inc. | 2025 | — |
| +1 | K242467 | IQ-UIP | Imbio, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA De Novo 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
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K252041 (Imvaria, Inc., 2025) has gone furthest, with 0 descendants of its own.
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?
Fibresolve is a software‐only device that receives and analyzes lung computed tomography (CT) imaging data in order to provide a diagnostic subtype classification in suspected cases of interstitial lung disease (ILD). The device supplements the standard-of‐care workflow by providing a qualitative, diagnostic classification output of imaging findings based on machine learning pattern recognition, in order to provide adjunctive information as part of a…
Read the full statement (174 words)
Fibresolve is a software‐only device that receives and analyzes lung computed tomography (CT) imaging data in order to provide a diagnostic subtype classification in suspected cases of interstitial lung disease (ILD). The device supplements the standard-of‐care workflow by providing a qualitative, diagnostic classification output of imaging findings based on machine learning pattern recognition, in order to provide adjunctive information as part of a referral pathway to an appropriate Multidisciplinary Discussion (MDD) or as part of an MDD. Specifically, the tool is used to serve as an adjunct in the diagnosis of idiopathic pulmonary fibrosis (IPF) prior to invasive testing. The results of Fibresolve are intended to be used only by clinicians qualified in the care of lung disease, specifically in caring for patients with ILD, in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment.
The input to Fibresolve is a DICOM‐compliant lung CT scan. Clinical case eligibility includes the following criteria:
Age > 22 years old.
Pulmonary symptoms suggestive of possible ILD including IPF.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN220040 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN220040: Fibresolve.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN220040
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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