# K193658: Viz ICH

- Pathway: 510(k) (Traditional)
- Applicant: Viz. Ai, Inc.
- Decided: Mar 18, 2020 after 79 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.
7 later devices descend from it; 4 cite it directly.
0 of 10 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 4.
- K180647: BriefCase, Aidoc Medical, Ltd. (2018) Summary page 4.

## Most influential descendants
- K210209: Viz ICH (2021), 3 descendants of its own
- K220439: Viz SDH (2022), 1 descendant of its own
- K243611: JLK-SDH (2025), 0 descendants of its own
- K243363: JLK-Ich (2025), 0 descendants of its own
- K241719: NeuroICH (2024), 0 descendants of its own

## Indications for use
Viz ICH 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. Viz ICH uses an artificial intelligence algorithm to analyze images for findings suggestive of a prespecified 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 neurovascular or neurosurgical specialist that a suspected intracranial hemorrhage 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 may be 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. Viz ICH 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. Viz ICH is contraindicated for analyzing non-contrast CT scans that are acquired on scanners from manufacturers other than General Electric (GE) or its subsidiaries (i.e. GE Healthcare). This contraindication applies to NCCT scans that conform to all applicable Patient Inclusion Criteria, are of adequate technical image quality, and would otherwise be expected to be analyzed by the device for a suspected ICH.

Source page: https://510kreport.com/device/K193658
Methodology: https://510kreport.com/methodology