510(k) · Cleared
ClearedDrAid for Radiology v1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vinbrain Joint Stock Company · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on Sep 1, 2022 as substantially equivalent to K190362 (Zebra Medical Vision, Ltd., 2019) after a 125-day review. Its family tree reaches back 3 generations to 2018.
- Decided
- Sep 1, 2022
- Review
- 125 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170073 (2018). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 QFM? 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 QFM device
- #1 K211733 Lunit INSIGHT CXR Triagescore 21.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K190362 | HealthPNXSummary page 5…validation or the analysis by the algorithm, an error is provided to the system. Predicate Device: DrAid™ for Radiology v1 is substantially equivalent to the HealthPNX (K190362) for Pneumothorax. Substantial Equivalence Comparison: A comparison of the subject and predicate device is provided in the table… | 2019 |
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?
- The line of descent spans 4 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K190362.
How does its category compare?
All QFM devicesQFM Radiological Computer-Assisted Prioritization Software For Lesions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QFM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QFM
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QFM
No recall names QFM since 2007.
Adverse event reports per year · QFM
No MAUDE report names QFM 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 | 4 | 97 | 0 | 0 |
| 2020 | 4 | 172 | 0 | 0 |
| 2021 | 5 | 187 | 0 | 0 |
| 2022 | 9 | 121 | 0 | 0 |
| 2023 | 8 | 206 | 0 | 0 |
| 2024 | 6 | 192 | 0 | 0 |
| 2025 | 3 | 100 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The DrAidTM for Radiology v1 is a radiological computer-assisted triage & notification software product designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of pneumothorax in medical care environment. DrAidTM analyzes cases using an artificial intelligence algorithm to features suggestive of suspected findings. It makes case-level output available to a PACS for worklist prioritization or triage. As a passive…
Read the full statement (133 words)
The DrAidTM for Radiology v1 is a radiological computer-assisted triage & notification software product designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of pneumothorax in medical care environment. DrAidTM analyzes cases using an artificial intelligence algorithm to features suggestive of suspected findings. It makes case-level output available to a PACS for worklist prioritization or triage.
As a passive notification for prioritization-only software tool with standard of care workflow, DrAidTM does not send a proactive alert directly to appropriately trained medical specialists. DrAidTM is not intended to direct attention to specific portions or anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out pneumothorax or otherwise preclude clinical assessment of X-Ray cases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221241 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221241: DrAid for Radiology v1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221241
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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