CCI PACS VIEWER (PACS-US-001)— 510(k) K254237

Name: FDA 510(k) clearance K254237
Creator: U.S. Food and Drug Administration
Published: 2026-04-23

Substantially Equivalent

CliniComp, Intl.

FDA 510(k) clearance K254237 for CCI PACS VIEWER (PACS-US-001), Substantially Equivalent on 2026-04-23. Applicant: CliniComp, Intl.. Device class: 2.

Summary

CliniComp's CCI PACS VIEWER (PACS-US-001) is filed under product code LLZ (System, Image Processing, Radiological). The record doesn't describe the software beyond its name and that code name.

Class II, 21 CFR 892.2050. It came in as a Traditional 510(k), and Radiology is both the classification panel and the review panel.

CliniComp filed from San Diego, California. Review took 115 calendar days (December 29, 2025 to April 23, 2026).

Clearance details

Applicant: CliniComp, Intl.
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-12-29
Decision date: 2026-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

K263648 — Vitrea Advanced Visualization, Version 7.162026-10-29
K261763 — MIM KineticID2026-10-26
K261531 — PV-iCurve Pro2026-10-21
K261788 — Eden PACS2026-10-21
K263048 — Syngo Carbon Space (VA4)2026-09-29

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.