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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 / December 2025 / K252919

510(k) cleared

IDENTIFY (5.0)

Varian Medical Systems, Inc. · Dec 16, 2025 · K252919

FDA cleared the IDENTIFY (5.0) from Varian Medical Systems, Inc. on Dec 16, 2025 under K252919, 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 12, 2025. The decision came 95 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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 K252919?

K252919 is the FDA 510(k) for IDENTIFY (5.0), submitted by Varian Medical Systems, Inc.. FDA's decision date was Dec 16, 2025, under product code IYE (Accelerator, Linear, Medical).

Who makes the IDENTIFY (5.0)?

Varian Medical Systems, Inc., based in Palo Alto, CA, is the applicant of record for K252919.

How long did the K252919 review take?

FDA received the submission on Sep 12, 2025 and issued its decision on Dec 16, 2025, 95 days later.

← All decisions in December 2025