# K223491: Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: May 25, 2023 after 185 days
- Product code: QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture)
- Device class: 2
- Regulation: 21 CFR 892.2090
- 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 DEN180005 (2018). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212365: BoneView, Gleamer (2022) Summary page 4.

## Indications for use
Critical Care Suite with Pneumothorax Detection Al Algorithm is a computer-aided triage, notification, and diagnostic device that analyzes frontal chest X-ray images for the presence of a pneumothorax. Critical Care Suite identifies and highlights images with a pneumothorax to enable case prioritization or triage and assist as a concurrent reading aide during interpretation of radiographs. Intended users include qualified independently licensed healthcare professionals (HCPs) trained to independently assess the presence of pneumothoraxes in radiographic images and radiologists. 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 adults and Transitional Adolescents (18 to <22 years old but treated like adults).

Source page: https://510kreport.com/device/K223491
Methodology: https://510kreport.com/methodology