Cci Pacs Viewer (PACS-US-001)

FDA 510(k) K254237 · CliniComp, Intl.

Substantially Equivalent

510(k) numberK254237

Submission

Device name
Cci Pacs Viewer (PACS-US-001)
Applicant
CliniComp, Intl.
San Diego, CA, US
Received
December 29, 2025
Decision date
April 23, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was Cci Pacs Viewer (PACS-US-001) cleared by the FDA?

Cci Pacs Viewer (PACS-US-001) (K254237) received a 510(k) decision of Substantially Equivalent on April 23, 2026, 115 days after the submission was received.

What is the product code of K254237?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.