# K220499: Rapid PE Triage and Notification (PETN)

- Pathway: 510(k) (Traditional)
- Applicant: Ischemaview, Inc.
- Decided: May 17, 2022 after 84 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: 3 generations back to DEN170073 (2018). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190072: BriefCase, Aidoc Medical, Ltd. (2019) Summary page 4.

## Most influential descendants
- K232751: BriefCase-Triage (2023), 0 descendants of its own

## Indications for use
Rapid PE Triage and Notification (PETN) is a radiological computer aided triage and notification software indicated for use in the analysis of CTPA images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of central pulmonary embolism (PE) pathology in adults. The software is only intended to be used on single-energy exams. Rapid PETN uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings 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 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 PETN are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care. Rapid PETN is validated for use on GE, Siemens and Toshiba scanners.

Source page: https://510kreport.com/device/K220499
Methodology: https://510kreport.com/methodology