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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 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.

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. 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.

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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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