# K211161: Critical Care Suite with Endotracheal Tube Positing AI algorithm

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Oct 29, 2021 after 193 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K935595 (1995). 87 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191647: QLAB Advanced Quantification Software, Philips Health Care (2019) Summary page 5.

## Most influential descendants
- K253502: Critical Care Suite with Enteric Tube Positioning AI Algorithm (2026), 0 descendants of its own

## Indications for use
Critical Care Suite is a suite of AI algorithms for the automated image analysis of frontal chest X-rays acquired on a digital x-ray system. Critical Care Suite with the Endotracheal Tube Positioning AI algorithm produces an on-screen image overlay that detects and localizes an endotracheal tube, locates the endotracheal tube tip, locates the carina, and automatically calculates the vertical distance between the endotracheal tube tip and carina. This information is also transmitted to the radiologist for review. Intended users include licensed qualified healthcare professionals (HCPs) trained to independently place and/or assess endotracheal tube placement and radiologists. Critical Care Suite with the Endotracheal Tube Positioning AI Algorithm 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 healthcare professional. Critical Care Suite with the Endotracheal Tube Positioning AI Algorithm is indicated for adult-sized patients.

Source page: https://510kreport.com/device/K211161
Methodology: https://510kreport.com/methodology