# K193300: AIMI-Triage CXR PTX

- Pathway: 510(k) (Traditional)
- Applicant: Radlogics, Inc.
- Decided: Apr 8, 2020 after 133 days
- Product code: QFM (Radiological Computer-Assisted Prioritization Software For Lesions)
- 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.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190362: HealthPNX, Zebra Medical Vision, Ltd. (2019) Summary page 4.

## Most influential descendants
- K213566: ClearRead Xray Pneumothorax (2022), 0 descendants of its own
- K211803: HealthPPT (2021), 0 descendants of its own

## Indications for use
The AIMI-Triage CXR PTX Application is a notification-only triage workflow tool for use by hospital networks and clinics to identify and help prioritize chest X-rays acquired in the acute setting for review by hospital radiologists. The device operates in parallel to and independent of standard of care image interpretation workflow. Specifically, the device uses an artificial intelligence algorithm to analyze images for features suggestive of moderate to large sized pneumothorax; it makes case-level output available to a PACS/workstation for worklist prioritization or triage. Identification of suspected cases of moderate to large sized pneumothorax is not for diagnostic use beyond notification. The AIMI-Triage CXR PTX Application is limited to analysis of imaging data as a guide to possible urgency of adult chest X-ray image review, and should not be used in lieu of full patient evaluation or relied upon to make or confirm diagnoses. Notified radiologists are responsible for engaging in appropriate patient evaluation as per local hospital procedure before making care-related decisions or requests. The device does not replace review and diagnosis of the X-rays by radiologists. The device is not intended to be used with plain film X-rays.

Source page: https://510kreport.com/device/K193300
Methodology: https://510kreport.com/methodology