FDA 510(k)

IntelePACS

Número K: K192176 · 2020-04-02

RequerenteIntelerad Medical Systems Incorporated

Data da decisão2020-04-02

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

IntelePACS is the device name listed in this FDA 510(k) record. The listed applicant is Intelerad Medical Systems Incorporated. It received FDA 510(k) clearance on 2020-04-02 under 510(k) number K192176. 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 IntelePACS?

IntelePACS is a medical device that received FDA 510(k) clearance on 2020-04-02. The listed applicant is Intelerad Medical Systems Incorporated. The 510(k) number is K192176.

When did IntelePACS receive FDA 510(k) clearance?

IntelePACS received FDA 510(k) clearance on 2020-04-02, under 510(k) number K192176.

Who is the listed applicant for IntelePACS?

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

What is the FDA product code for IntelePACS?

The FDA product code for IntelePACS is LLZ.

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