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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 / October 2025 / K251363

510(k) cleared

ProKnow DS

Elekta Solutions AB · Oct 8, 2025 · K251363

FDA cleared the ProKnow DS from Elekta Solutions AB on Oct 8, 2025 under K251363, 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 May 1, 2025. The decision came 160 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Elekta Solutions AB has 3 other decisions in the tracker over the last 12 months: K261932 (Leksell® Vantage Stereotactic System), K252002 (Monaco RTP System (6.3)), K252188 (EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)).

Questions & Answers

What did FDA clear under K251363?

K251363 is the FDA 510(k) for ProKnow DS, submitted by Elekta Solutions AB. FDA's decision date was Oct 8, 2025, under product code LLZ (System, Image Processing, Radiological).

Who makes the ProKnow DS?

Elekta Solutions AB, based in Stockholm, is the applicant of record for K251363.

How long did the K251363 review take?

FDA received the submission on May 1, 2025 and issued its decision on Oct 8, 2025, 160 days later.

← All decisions in October 2025

Sources