FDA 510(k)

긴급 치료 스푼트와 엔터릭 튜브 위치 정확화 AI 알고리즘

K-번호: K253502 · 2026-04-14

결정일2026-04-14

제품 코드QIH

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

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기기 요약

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.

자주 묻는 질문

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.

Ge Medical Systems, LLC를 신청인으로 등재한 기타 기록

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