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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 / K252258

510(k) cleared

VERIQA RT EPID 3D

Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla · Apr 15, 2026 · K252258

FDA cleared the VERIQA RT EPID 3D from Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla on Apr 15, 2026 under K252258, a traditional 510(k). The device falls under product code IYE, Accelerator, Linear, Medical, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 21, 2025. The decision came 268 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 Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252258?

K252258 is the FDA 510(k) for VERIQA RT EPID 3D, submitted by Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla. FDA's decision date was Apr 15, 2026, under product code IYE (Accelerator, Linear, Medical).

Who makes the VERIQA RT EPID 3D?

Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla, based in Freiburg, is the applicant of record for K252258.

How long did the K252258 review take?

FDA received the submission on Jul 21, 2025 and issued its decision on Apr 15, 2026, 268 days later.

← All decisions in April 2026