Critical Care Suite with Enteric Tube Positioning AI Algorithm— 510(k) K253502

Name: FDA 510(k) clearance K253502
Creator: U.S. Food and Drug Administration
Published: 2026-04-14

Substantially Equivalent

Ge Medical Systems, LLC

FDA 510(k) clearance K253502 for Critical Care Suite with Enteric Tube Positioning AI Algorithm, Substantially Equivalent on 2026-04-14. Applicant: Ge Medical Systems, LLC. Device class: 2.

Clearance details

Applicant: Ge Medical Systems, LLC
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-10-30
Decision date: 2026-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.