FDA 510(k)

CCI PACS VIEWER (PACS-US-001)

Número K: K254237 · 2026-04-23

Data da decisão2026-04-23

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

CCI PACS VIEWER (PACS-US-001) is the device name listed in this FDA 510(k) record. The listed applicant is CliniComp, Intl.. It received FDA 510(k) clearance on 2026-04-23 under 510(k) number K254237. 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 CCI PACS VIEWER (PACS-US-001)?

CCI PACS VIEWER (PACS-US-001) is a medical device that received FDA 510(k) clearance on 2026-04-23. The listed applicant is CliniComp, Intl.. The 510(k) number is K254237.

When did CCI PACS VIEWER (PACS-US-001) receive FDA 510(k) clearance?

CCI PACS VIEWER (PACS-US-001) received FDA 510(k) clearance on 2026-04-23, under 510(k) number K254237.

Who is the listed applicant for CCI PACS VIEWER (PACS-US-001)?

The FDA 510(k) record lists CliniComp, Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CCI PACS VIEWER (PACS-US-001)?

The FDA product code for CCI PACS VIEWER (PACS-US-001) is LLZ.

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