FDA 510(k)

Automatic Anatomy Recognition (AAR)

Número K: K203610 · 2021-04-20

RequerenteQuantitative Radiology Solutions, LLC

Data da decisão2021-04-20

Código do produtoQKB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Automatic Anatomy Recognition (AAR) is the device name listed in this FDA 510(k) record. The listed applicant is Quantitative Radiology Solutions, LLC. It received FDA 510(k) clearance on 2021-04-20 under 510(k) number K203610. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Automatic Anatomy Recognition (AAR)?

Automatic Anatomy Recognition (AAR) is a medical device that received FDA 510(k) clearance on 2021-04-20. The listed applicant is Quantitative Radiology Solutions, LLC. The 510(k) number is K203610.

When did Automatic Anatomy Recognition (AAR) receive FDA 510(k) clearance?

Automatic Anatomy Recognition (AAR) received FDA 510(k) clearance on 2021-04-20, under 510(k) number K203610.

Who is the listed applicant for Automatic Anatomy Recognition (AAR)?

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

What is the FDA product code for Automatic Anatomy Recognition (AAR)?

The FDA product code for Automatic Anatomy Recognition (AAR) is QKB.

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