FDA 510(k)

TruPlan Computed Tomography (CT) Imaging Software

Número K: K222593 · 2023-01-18

RequerenteCircle Cardiovascular Imaging, Inc.

Data da decisão2023-01-18

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

TruPlan Computed Tomography (CT) Imaging Software is the device name listed in this FDA 510(k) record. The listed applicant is Circle Cardiovascular Imaging, Inc.. It received FDA 510(k) clearance on 2023-01-18 under 510(k) number K222593. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TruPlan Computed Tomography (CT) Imaging Software?

TruPlan Computed Tomography (CT) Imaging Software is a medical device that received FDA 510(k) clearance on 2023-01-18. The listed applicant is Circle Cardiovascular Imaging, Inc.. The 510(k) number is K222593.

When did TruPlan Computed Tomography (CT) Imaging Software receive FDA 510(k) clearance?

TruPlan Computed Tomography (CT) Imaging Software received FDA 510(k) clearance on 2023-01-18, under 510(k) number K222593.

Who is the listed applicant for TruPlan Computed Tomography (CT) Imaging Software?

The FDA 510(k) record lists Circle Cardiovascular Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TruPlan Computed Tomography (CT) Imaging Software?

The FDA product code for TruPlan Computed Tomography (CT) Imaging Software is LLZ.

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Fonte oficial

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