# K213566: ClearRead Xray Pneumothorax

- Pathway: 510(k) (Traditional)
- Applicant: Riverain Technologies, Inc.
- Decided: Mar 10, 2022 after 121 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: 4 generations back to DEN170073 (2018). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193300: AIMI-Triage CXR PTX, Radlogics, Inc. (2020) Summary page 5.

## Indications for use
ClearRead Xray Pneumothorax is a notification-only triage workflow tool for use by trained professionals to help prioritize chest X-rays. 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 a pneumothorax 5 mm or larger; it makes case-level output available to a PACS/workstation for worklist prioritization or triage. Identification of suspected cases of a pneumothorax is not for diagnostic use beyond notification. ClearRead Xray Pneumothorax 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. The device does not replace review and diagnosis of the X-rays by trained professionals. The device is not intended to be used with plain film X-ray.

Source page: https://510kreport.com/device/K213566
Methodology: https://510kreport.com/methodology