FDA 510(k)

Aura 10 PET/CT

K号: K231420 · 2023-08-10

决定日期2023-08-10

产品代码QXL

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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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