FDA 510(k)

UltraSight AI Guidance

K-번호: K223347 · 2023-07-24

결정일2023-07-24

제품 코드QJU

자문 위원회RA

결정Substantially Equivalent

기기 요약

UltraSight AI Guidance is the device name listed in this FDA 510(k) record. The listed applicant is Ultrasight, Inc.. It received FDA 510(k) clearance on 2023-07-24 under 510(k) number K223347. The device is classified under product code QJU. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the UltraSight AI Guidance?

UltraSight AI Guidance is a medical device that received FDA 510(k) clearance on 2023-07-24. The listed applicant is Ultrasight, Inc.. The 510(k) number is K223347.

When did UltraSight AI Guidance receive FDA 510(k) clearance?

UltraSight AI Guidance received FDA 510(k) clearance on 2023-07-24, under 510(k) number K223347.

Who is the listed applicant for UltraSight AI Guidance?

The FDA 510(k) record lists Ultrasight, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UltraSight AI Guidance?

The FDA product code for UltraSight AI Guidance is QJU.

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UltraSight AI Guidance

기기 요약

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관련 임상시험

관련 기기 (코드: QJU)

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