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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 / K252948

510(k) cleared

TrueBeam, TrueBeam STX, Edge and VitalBeam

Varian Medical Systems, Inc. · Oct 7, 2025 · K252948

FDA cleared the TrueBeam, TrueBeam STX, Edge and VitalBeam from Varian Medical Systems, Inc. on Oct 7, 2025 under K252948, 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 Sep 16, 2025. The decision came 21 days later, inside the 90 FDA-day goal for a 510(k).

Varian Medical Systems, Inc. has 8 other decisions in the tracker over the last 12 months: K261856 (Halcyon, Ethos Radiotherapy System (5.0)), K261306 (AI Contouring (VA10A)), K260750 (Virtual Cone (1.0)), K253026 (Respiratory Gating for Scanners (2.1)).

Questions & Answers

What did FDA clear under K252948?

K252948 is the FDA 510(k) for TrueBeam, TrueBeam STX, Edge and VitalBeam, submitted by Varian Medical Systems, Inc.. FDA's decision date was Oct 7, 2025, under product code IYE (Accelerator, Linear, Medical).

Who makes the TrueBeam, TrueBeam STX, Edge and VitalBeam?

Varian Medical Systems, Inc., based in Palo Alto, CA, is the applicant of record for K252948.

How long did the K252948 review take?

FDA received the submission on Sep 16, 2025 and issued its decision on Oct 7, 2025, 21 days later.

← All decisions in October 2025