510(k) · Cleared
ClearedNinesAI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nines, Inc. · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Apr 21, 2020 as substantially equivalent to K180647 (Aidoc Medical, Ltd., 2018) after a 140-day review. Its family tree reaches back 2 generations to 2018. 1 later device descends from it.
- Decided
- Apr 21, 2020
- Review
- 140 days
- Class
- Class II
- Product code
- QAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170073 (2018). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K231384Annalise Enterprise CTB Triage TraumaAnnalise-Ai Pty, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −1 | K180647 | BriefCase | Aidoc Medical, Ltd. | 2018 | — |
| 0 (this device) | K193351 | NinesAI | Nines, Inc. | 2020 | — |
| +1 | K231384 | Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K180647 | BriefCaseSummary page 4…cation Name: Radiological Computer-Assisted Triage and Notification Software Regulatory Class: Class II Product Code: QAS Predicate Device: Aidoc Medical’s BriefCase (K180647) Device Description NinesAl notifies a radiologist of the presence of a suspected critical abnormality in a radiological image.… | 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 |
|---|---|---|---|
| K231384 | Annalise Enterprise CTB Triage Trauma | 2023 | 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?
- The line of descent spans 2 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K231384 (Annalise-Ai Pty, Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K180647.
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?
NinesAI is a parallel workflow tool indicated for use by hospital networks and trained clinicians to identify images of specific patients to a radiologist, independent of standard of care workflow, to aid in prioritizing and performing the radiological review. NinesAI uses artificial intelligence algorithms to analyze head CT images for findings suggestive of a pre-specified emergent clinical condition. The software automatically analyzes Digital Imaging…
Read the full statement (186 words)
NinesAI is a parallel workflow tool indicated for use by hospital networks and trained clinicians to identify images of specific patients to a radiologist, independent of standard of care workflow, to aid in prioritizing and performing the radiological review. NinesAI uses artificial intelligence algorithms to analyze head CT images for findings suggestive of a pre-specified emergent clinical condition.
The software automatically analyzes Digital Imaging and Communications in Medicine (DICOM) images as they arrive in the Picture Archive and Communication System (PACS) using machine learning algorithms. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the software analyzes head CT images of the brain to assess the suspected presence of intracranial hemorrhage and/or mass effect and identifies images with potential emergent findings in a radiologist’s worklist.
NinesAI is intended to be used as a triage tool limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm a diagnosis. Additionally, preview images displayed to the radiologist outside of the DICOM viewer are non-diagnostic quality and should only be used for informational purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193351: NinesAI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193351
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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