510(k) · Cleared
ClearedRed Dot
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Behold.Ai Technologies Limited · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on Feb 28, 2020 as substantially equivalent to K190362 (Zebra Medical Vision, Ltd., 2019) after a 261-day review. Its family tree reaches back 3 generations to 2018. 6 later devices descend from it.
- Decided
- Feb 28, 2020
- Review
- 261 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170073 (2018). 6 later devices descend from it, 3 citing it directly.
- Root · 3 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 2 generations backK183285 cmTriageCuremetrix, Inc. · 2019
- 1 generation backK190362 HealthPNXZebra Medical Vision, Ltd. · 2019
- This deviceK191556 Red DotBehold.Ai Technologies Limited · 2020
- Descendant · cites it directly · 3 of its ownK213941 Annalise Enterprise CXR Triage PneumothoraxAnnalise-Ai · 2022
- Descendant · 2 generations on · 1 of its ownK222179 Annalise Enterprise CXR Triage TraumaAnnalise-Ai Pty, Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK250831 Annalise EnterpriseAnnalise-Ai · 2025
- Descendant · 2 generations on · 0 of its ownK222268 Annalise Enterprise CXR Triage TraumaAnnalise-Ai Pty, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK221552 EFAI ChestSuite XR Pneumothorax Assessment SystemEver Fortune.Ai, Co., Ltd. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K213941Annalise Enterprise CXR Triage PneumothoraxAnnalise-Ai · 2022 · cites it directly3descendants
- K222179Annalise Enterprise CXR Triage TraumaAnnalise-Ai Pty, Ltd. · 2023 · 2 generations on1descendant
- K250831Annalise EnterpriseAnnalise-Ai · 2025 · 3 generations on0descendants
- K222268Annalise Enterprise CXR Triage TraumaAnnalise-Ai Pty, Ltd. · 2023 · 2 generations on0descendants
- K221552EFAI ChestSuite XR Pneumothorax Assessment SystemEver Fortune.Ai, Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −2 | K183285 | cmTriage | Curemetrix, Inc. | 2019 | — |
| −1 | K190362 | HealthPNX | Zebra Medical Vision, Ltd. | 2019 | — |
| 0 (this device) | K191556 | Red Dot | Behold.Ai Technologies Limited | 2020 | — |
| +1 | K213941 | Annalise Enterprise CXR Triage Pneumothorax | Annalise-Ai | 2022 | — |
| +2 | K222179 | Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty, Ltd. | 2023 | — |
| +3 | K250831 | Annalise Enterprise | Annalise-Ai | 2025 | — |
| +2 | K222268 | Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty, Ltd. | 2023 | — |
| +1 | K221552 | EFAI ChestSuite XR Pneumothorax Assessment System | Ever Fortune.Ai, Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
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 4…to the following device: Manufacturer Name Zebra Medical Vision Ltd. Devices Trade Name HealthPNX 510(k) Number K190362 A. Device Description Behold.ai red dot™ is a radiological computer-assisted triage and notification software system. The soft… | 2019 |
What descends from it? (6)
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?
- The line of descent spans 2 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K213941 (Annalise-Ai, 2022) has gone furthest, with 3 descendants of its own.
- 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. 2020, 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 red dot™ software platform is a software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment. red dot™ analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. red dot™ is not intended to direct attention to specific…
Read the full statement (108 words)
The red dot™ software platform is a software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment. red dot™ analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. red dot™ is not intended to direct attention to specific portions of an image or to anomalies other than Pneumothorax. 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/K191556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191556: Red Dot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191556
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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