# K253502: Critical Care Suite with Enteric Tube Positioning AI Algorithm

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Apr 14, 2026 after 166 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: 18 generations back to K935595 (1995). 88 ancestors in all.
No later device cites it as a predicate yet.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211161: Critical Care Suite with Endotracheal Tube Positing AI algorithm, Ge Medical Systems, LLC (2021) Summary page 5.

## Indications for use
Critical Care Suite with Enteric Tube AI Algorithm analyzes frontal chest and abdominal x-ray images and produces an on-screen image overlay that detects and localizes an enteric tube that has been inserted nasally or orally, locates the tube tip, and locates the tube side port (if present). It also produces an on-screen image overlay that detects and localizes the diaphragm and the airways (carina with left and right bronchi). This information is also transmitted to the radiologist for review. Intended users include licensed qualified healthcare professional (HCP) who have been trained to independently place and/or assess the placement of enteric tubes inserted nasally or orally and radiologists. Critical Care Suite with the Enteric 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 Enteric Tube Positioning AI algorithm is indicated for both adult and pediatric patients.

Source page: https://510kreport.com/device/K253502
Methodology: https://510kreport.com/methodology