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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K254237

510(k) cleared

CCI PACS VIEWER (PACS-US-001)

CliniComp, Intl. · Apr 23, 2026 · K254237

FDA cleared the CCI PACS VIEWER (PACS-US-001) from CliniComp, Intl. on Apr 23, 2026 under K254237, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 29, 2025. The decision came 115 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for CliniComp, Intl. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254237?

K254237 is the FDA 510(k) for CCI PACS VIEWER (PACS-US-001), submitted by CliniComp, Intl.. FDA's decision date was Apr 23, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the CCI PACS VIEWER (PACS-US-001)?

CliniComp, Intl., based in San Diego, CA, is the applicant of record for K254237.

How long did the K254237 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Apr 23, 2026, 115 days later.

← All decisions in April 2026