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

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.

Clearance details

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

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