FDA 510(k)

아우라 10 PET/CT

K-번호: K231420 · 2023-08-10

결정일2023-08-10

제품 코드QXL

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

결정대체적으로 동일

기기 요약

Aura 10 PET/CT is the device name listed in this FDA 510(k) record. The listed applicant is Xeos Medical. It received FDA 510(k) clearance on 2023-08-10 under 510(k) number K231420. The device is classified under product code QXL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Aura 10 PET/CT?

Aura 10 PET/CT is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is Xeos Medical. The 510(k) number is K231420.

When did Aura 10 PET/CT receive FDA 510(k) clearance?

Aura 10 PET/CT received FDA 510(k) clearance on 2023-08-10, under 510(k) number K231420.

Who is the listed applicant for Aura 10 PET/CT?

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

What is the FDA product code for Aura 10 PET/CT?

The FDA product code for Aura 10 PET/CT is QXL.

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