510(k) · Cleared
ClearedScreenDx
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.
Cleared on Jan 10, 2025 as substantially equivalent to DEN220040 (Imvaria, Inc., 2024) after a 196-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Jan 10, 2025
- Review
- 196 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 deviceK241891 ScreenDxImvaria, Inc. · 2025
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) | K241891 | ScreenDx | Imvaria, Inc. | 2025 | — |
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 5…ICE IDENTIFICATION ScreenDx is substantially equivalent to the following predicate: 510(k) Number Device/Manufacturer Predicate/Reference DEN220040 Fibresolve / Imvaria, Inc Predicate DEVICE DESCRIPTION ScreenDx is a computer-assisted analys… | 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. 2025, 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?
ScreenDx is a software-only device that receives and analyzes lung computed tomography (CT) imaging data in order to assess for interstitial lung findings compatible with interstitial lung disease. The device supplements the standard-of-care workflow by providing a qualitative output of imaging findings based on pattern recognition, in order to provide adjunctive information as part of a referral pathway to an appropriately qualified clinician. Patients…
Read the full statement (166 words)
ScreenDx is a software-only device that receives and analyzes lung computed tomography (CT) imaging data in order to
assess for interstitial lung findings compatible with interstitial lung disease. The device supplements the standard-of-care
workflow by providing a qualitative output of imaging findings based on pattern recognition, in order to provide
adjunctive information as part of a referral pathway to an appropriately qualified clinician. Patients with positively
identified patterns may undergo assessment for lung fibrosis, but ScreenDx does not replace the current standard of care
methods for diagnosis of lung fibrosis and the results of the device are not intended to rule-out or rule-in lung fibrosis.
The results of ScreenDx are intended to be used only by clinicians qualified in the care of lung disease, in conjunction
with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment.
The input to ScreenDx is a DICOM-compliant lung CT scan. Clinical case eligibility includes the following criteria:
• Age > 22 years old.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241891 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241891: ScreenDx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241891
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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