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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 / September 2025 / K252608

510(k) cleared

AI-Rad Companion Prostate MR

Siemens Healthcare GmbH · Sep 9, 2025 · K252608

FDA cleared the AI-Rad Companion Prostate MR from Siemens Healthcare GmbH on Sep 9, 2025 under K252608, a traditional 510(k) reviewed through the Third Party Review Program. 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 Aug 18, 2025. The decision came 22 days later, inside the 90 FDA-day goal for a 510(k).

Siemens Healthcare GmbH has 8 other decisions in the tracker over the last 12 months: K253985 (INNOVANCE® D-Dimer 2.0 (SMN 10873803)), K253528 (Atellica IM CA 19-9 II), K261364 (Atellica CH Acetaminophen 2 (ACTM)), K253264 (myAblation Guide (VC10A)).

Questions & Answers

What did FDA clear under K252608?

K252608 is the FDA 510(k) for AI-Rad Companion Prostate MR, submitted by Siemens Healthcare GmbH. FDA's decision date was Sep 9, 2025, under product code LLZ (System, Image Processing, Radiological).

Who makes the AI-Rad Companion Prostate MR?

Siemens Healthcare GmbH, based in Erlanger, is the applicant of record for K252608.

How long did the K252608 review take?

FDA received the submission on Aug 18, 2025 and issued its decision on Sep 9, 2025, 22 days later.

← All decisions in September 2025