510(k) · Cleared
ClearedHALO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nico-Lab B.V. · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Nov 20, 2020 as substantially equivalent to DEN170073 (Viz.Al, Inc., 2018) after a 233-day review. Its family tree reaches back 1 generation to 2018. 1 later device descends from it.
- Decided
- Nov 20, 2020
- Review
- 233 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170073 (2018). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K211788HALONicolab B.V. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| 0 (this device) | K200873 | HALO | Nico-Lab B.V. | 2020 | — |
| +1 | K211788 | HALO | Nicolab B.V. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 QAS? 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 QAS device
- #1 K203508 BriefCasescore 25.5 · 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 |
|---|---|---|---|
| * | DEN170073 | ContaCTSummary page 4…uct Code: QAS Primary Predicate Trade Name: ContaCT Device: Manufacturer: Viz.Al, Inc. DeNovo Clearance: DEN170073 Classification Name: Radiological Computer-Assissted Triage and… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211788 | HALO | 2021 | 0 |
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?
How does its category compare?
All QAS devicesQAS Radiological Computer-Assisted Triage And Notification Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QAS
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QAS
101in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QAS
No recall names QAS since 2007.
Adverse event reports per year · QAS
No MAUDE report names QAS 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 | 3 | — | 0 | 0 |
| 2019 | 5 | 111 | 0 | 0 |
| 2020 | 12 | 112 | 0 | 0 |
| 2021 | 5 | 86 | 0 | 0 |
| 2022 | 15 | 116 | 0 | 0 |
| 2023 | 11 | 98 | 0 | 0 |
| 2024 | 12 | 136 | 0 | 0 |
| 2025 | 15 | 101 | 0 | 0 |
| 2026 | 11 | 104 | 0 | — |
What is it indicated for?
HALO is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation. Its intended use is to identify suggestive imaging patterns of a pre-specified clinical condition and to directly notify an appropriate medical specialist. HALO’s indication is to facilitate the evaluation of the brain vasculature on patients…
Read the full statement (200 words)
HALO is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation. Its intended use is to identify suggestive imaging patterns of a pre-specified clinical condition and to directly notify an appropriate medical specialist.
HALO’s indication is to facilitate the evaluation of the brain vasculature on patients suspected of stroke by processing and analyzing contrast enhanced CT angiograms of the brain acquired in an acute setting. After completion of the data analysis, HALO sends a notification if a pattern suggestive for a suspected intracranial Large Vessel Occlusion (LVO) of the anterior circulation (ICA, M1 or M2) has been identified in an image.
The intended users of HALO are defined as appropriate medical specialists or a team of specialists that are involved in the diagnosis and care of stroke patients at emergency departments or other department where stroke patients are administered. They include physicians such as neurologists, radiologists, and/or other emergency department physicians.
HALO’s output should not be used for primary diagnosis or clinical decisions; the final diagnosis is always decided upon by the medical specialist. HALO is indicated for CT scanners from GE Healthcare.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200873 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200873: HALO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200873
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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