FDA 510(k)

Critical Care Suite with Enteric Tube Positioning AI Algorithm

Número K: K253502 · 2026-04-14

Data da decisão2026-04-14

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Critical Care Suite with Enteric Tube Positioning AI Algorithm is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2026-04-14 under 510(k) number K253502. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Critical Care Suite with Enteric Tube Positioning AI Algorithm?

Critical Care Suite with Enteric Tube Positioning AI Algorithm is a medical device that received FDA 510(k) clearance on 2026-04-14. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K253502.

When did Critical Care Suite with Enteric Tube Positioning AI Algorithm receive FDA 510(k) clearance?

Critical Care Suite with Enteric Tube Positioning AI Algorithm received FDA 510(k) clearance on 2026-04-14, under 510(k) number K253502.

Who is the listed applicant for Critical Care Suite with Enteric Tube Positioning AI Algorithm?

The FDA 510(k) record lists Ge Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Critical Care Suite with Enteric Tube Positioning AI Algorithm?

The FDA product code for Critical Care Suite with Enteric Tube Positioning AI Algorithm is QIH.

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