FDA 510(k)

Ortho AI

K-번호: K241696 · 2025-01-02

결정일2025-01-02

제품 코드QIH

자문 위원회RA

결정Substantially Equivalent

기기 요약

Ortho AI is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Ai, LLC. It received FDA 510(k) clearance on 2025-01-02 under 510(k) number K241696. 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 Ortho AI?

Ortho AI is a medical device that received FDA 510(k) clearance on 2025-01-02. The listed applicant is Ortho Ai, LLC. The 510(k) number is K241696.

When did Ortho AI receive FDA 510(k) clearance?

Ortho AI received FDA 510(k) clearance on 2025-01-02, under 510(k) number K241696.

Who is the listed applicant for Ortho AI?

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

What is the FDA product code for Ortho AI?

The FDA product code for Ortho AI is QIH.

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Ortho AI

기기 요약

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관련 임상시험

관련 기기 (코드: QIH)

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