FDA 510(k)

syngo.CT Lung CAD (Version VD30)

K-번호: K231157 · 2023-07-19

결정일2023-07-19

제품 코드OEB

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

결정대체적으로 동일

기기 요약

syngo.CT Lung CAD (Version VD30) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2023-07-19 under 510(k) number K231157. The device is classified under product code OEB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the syngo.CT Lung CAD (Version VD30)?

syngo.CT Lung CAD (Version VD30) is a medical device that received FDA 510(k) clearance on 2023-07-19. The listed applicant is Siemens Healthcare GmbH. The 510(k) number is K231157.

When did syngo.CT Lung CAD (Version VD30) receive FDA 510(k) clearance?

syngo.CT Lung CAD (Version VD30) received FDA 510(k) clearance on 2023-07-19, under 510(k) number K231157.

Who is the listed applicant for syngo.CT Lung CAD (Version VD30)?

The FDA 510(k) record lists Siemens Healthcare GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for syngo.CT Lung CAD (Version VD30)?

The FDA product code for syngo.CT Lung CAD (Version VD30) is OEB.

Siemens Healthcare GmbH를 신청인으로 등재한 기타 기록

K253264myAblation Guide (VC10A)K253689syngo Dynamics (VA41F)K252548AI-Rad 컴패니언 기관 K253057AI-Rad 컴패니언 뇌 MRI K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise K252608AI-Rad 컴패니언 전립선 MRI

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