# K193351: NinesAI

- Pathway: 510(k) (Traditional)
- Applicant: Nines, Inc.
- Decided: Apr 21, 2020 after 140 days
- Product code: QAS (Radiological Computer-Assisted Triage And Notification Software)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN170073 (2018). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180647: BriefCase, Aidoc Medical, Ltd. (2018) Summary page 4.

## Most influential descendants
- K231384: Annalise Enterprise CTB Triage Trauma (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K193351
Methodology: https://510kreport.com/methodology