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FDA 510(k)

CCI PACS VIEWER (PACS-US-001)

K-Number: K254237 · 2026-04-23

ApplicantCliniComp, Intl.
Decision Date2026-04-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CCI PACS VIEWER (PACS-US-001) is a medical device manufactured by CliniComp, Intl.. It received FDA 510(k) clearance on 2026-04-23 under approval number K254237. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by CliniComp, Intl.. The 510(k) number is K254237.

When was CCI PACS VIEWER (PACS-US-001) approved by the FDA?

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

What company makes CCI PACS VIEWER (PACS-US-001)?

CCI PACS VIEWER (PACS-US-001) is manufactured by CliniComp, Intl..

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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