De Novo · Granted
GrantedContaCT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viz.Al, Inc. · QAS Radiological Computer-Assisted Triage And Notification Software
Granted on Feb 13, 2018 as a new device type through De Novo after a 137-day review. 128 later devices descend from it.
- Decided
- Feb 13, 2018
- Review
- 137 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
128 later devices descend from it, 10 citing it directly.
- This deviceDEN170073 ContaCTViz.Al, Inc. · 2018
- Descendant · cites it directly · 73 of its ownK180647 BriefCaseAidoc Medical, Ltd. · 2018
- Descendant · cites it directly · 37 of its ownK183285 cmTriageCuremetrix, Inc. · 2019
- Descendant · 2 generations on · 30 of its ownK190072 BriefCaseAidoc Medical, Ltd. · 2019
- Descendant · 2 generations on · 23 of its ownK190362 HealthPNXZebra Medical Vision, Ltd. · 2019
- Descendant · 2 generations on · 20 of its ownK193298 BriefCaseAidoc Medical, Ltd. · 2020
Showing 5 of 128 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 128 · See all- K180647BriefCaseAidoc Medical, Ltd. · 2018 · cites it directly73descendants
- K183285cmTriageCuremetrix, Inc. · 2019 · cites it directly37descendants
- K190072BriefCaseAidoc Medical, Ltd. · 2019 · 2 generations on30descendants
- K190362HealthPNXZebra Medical Vision, Ltd. · 2019 · 2 generations on23descendants
- K193298BriefCaseAidoc Medical, Ltd. · 2020 · 2 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| +1 | K180647 | BriefCase | Aidoc Medical, Ltd. | 2018 | — |
| +1 | K183285 | cmTriage | Curemetrix, Inc. | 2019 | — |
| +2 | K190072 | BriefCase | Aidoc Medical, Ltd. | 2019 | — |
| +2 | K190362 | HealthPNX | Zebra Medical Vision, Ltd. | 2019 | — |
| +2 | K193298 | BriefCase | Aidoc Medical, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 9 | 0 |
| 2020 | 16 | 0 |
| 2021 | 10 | 0 |
| 2022 | 24 | 0 |
| 2023 | 19 | 0 |
| 2024 | 18 | 0 |
| 2025 | 18 | 0 |
| 2026 | 12 | 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 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (128)
See all 12810 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, K180647 (Aidoc Medical, Ltd., 2018) has gone furthest, with 73 descendants of its own.
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. 2018, 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?
ContaCT is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow. ContaCT uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image…
Read the full statement (193 words)
ContaCT is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow.
ContaCT uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Specifically, the device analyzes CT angiogram images of the brain acquired in the acute setting, and sends notifications to a neurovascular specialist that a suspected large vessel occlusion has been identified and recommends review of those images. Images can be previewed through a mobile application.
Images that are previewed through the mobile application are compressed and are for informational purposes only and not intended for diagnostic use beyond notification. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests. ContaCT is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170073 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN170073: ContaCT.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN170073
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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