FDA 510(k)

オーラ10 PET/CT

K番号: K231420 · 2023-08-10

決定日2023-08-10

製品コードQXL

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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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