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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 / June 2026 / K260231

510(k) cleared

MiPACS V5 (1.0.0)

Apryse Software Corp · Jun 25, 2026 · K260231

FDA cleared the MiPACS V5 (1.0.0) from Apryse Software Corp on Jun 25, 2026 under K260231, 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 Jan 26, 2026. The decision came 150 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 Apryse Software Corp in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260231?

K260231 is the FDA 510(k) for MiPACS V5 (1.0.0), submitted by Apryse Software Corp. FDA's decision date was Jun 25, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the MiPACS V5 (1.0.0)?

Apryse Software Corp, based in Denver, CO, is the applicant of record for K260231.

How long did the K260231 review take?

FDA received the submission on Jan 26, 2026 and issued its decision on Jun 25, 2026, 150 days later.

← All decisions in June 2026