# K182875: DeepCT

- Pathway: 510(k) (Traditional)
- Applicant: Deep01 Limited
- Decided: Jul 10, 2019 after 271 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.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170073: ContaCT, Viz.Al, Inc. (2018) Summary page 5.
- K180647: BriefCase, Aidoc Medical, Ltd. (2018) Summary page 5.

## Indications for use
DeepCT 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. DeepCT 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. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyzes non-contrast CT images of the brain acquired in the acute setting and sends notifications to a specialist that a suspected ICH (intracranial hemorrhage) has been identified and recommends review of those images. Notified clinicians are responsible for viewing non-contrast CT images of the brain on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating specialist before making care-related decisions or requests. DeepCT 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.

Source page: https://510kreport.com/device/K182875
Methodology: https://510kreport.com/methodology