# K183182: Critical Care Suite

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Aug 12, 2019 after 266 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.
8 later devices descend from it; 1 cites it directly.
0 of 12 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). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K211733: Lunit INSIGHT CXR Triage (2021), 7 descendants of its own
- K230899: qXR-PTX-PE (2023), 1 descendant of its own
- K253751: CXRDetectAI (2026), 0 descendants of its own
- K243808: Rayvolve PTX-PE (2025), 0 descendants of its own
- K241439: VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage (2024), 0 descendants of its own

## Indications for use
Critical Care Suite is a computer aided triage and notification device that analyzes frontal chest x-ray images for the presence of prespecified critical findings (pneumothorax). Critical Care Suite identifies images with critical findings to enable case prioritization or triage in the PACS/workstation. Critical Care Suite is intended for notification only and does not provide diagnostic information beyond the notification. Critical Care Suite should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. It is not intended to replace the review of the x-ray image by a qualified physician. Critical Care Suite is indicated for adult-size patients.

Source page: https://510kreport.com/device/K183182
Methodology: https://510kreport.com/methodology