# K193087: Rapid ICH

- Pathway: 510(k) (Traditional)
- Applicant: Ischemaview Incorporated
- Decided: Mar 31, 2020 after 146 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; 2 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)
- K180647: BriefCase, Aidoc Medical, Ltd. (2018) Summary page 4.

## Most influential descendants
- K200941: Rapid LVO (2020), 3 descendants of its own
- K221456: Rapid ICH (2022), 2 descendants of its own
- K251151: Rapid CTA 360 (2025), 1 descendant of its own
- K232436: Rapid SDH (2023), 1 descendant of its own
- K261085: Rapid Vessel Occlusion (Rapid VO) (2026), 0 descendants of its own

## Indications for use
RAPID ICH is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of pathologies in head CT images, namely Intracranial Hemorrhage (ICH). RAPID ICH uses an artificial intelligence algorithm to analyze images and highlight cases with detected ICH on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH findings. Notifications include compressed preview images, that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of RAPID ICH are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage /prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.

Source page: https://510kreport.com/device/K193087
Methodology: https://510kreport.com/methodology