WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / June 2026 / K253026

510(k) cleared

Respiratory Gating for Scanners (2.1)

Varian Medical Systems, Inc. · Jun 4, 2026 · K253026

FDA cleared the Respiratory Gating for Scanners (2.1) from Varian Medical Systems, Inc. on Jun 4, 2026 under K253026, a traditional 510(k). The device falls under product code JAK, System, X-Ray, Tomography, Computed, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 19, 2025. The decision came 258 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)), K252717 (MAASTRO Rectal Applicator Set).

Questions & Answers

What did FDA clear under K253026?

K253026 is the FDA 510(k) for Respiratory Gating for Scanners (2.1), submitted by Varian Medical Systems, Inc.. FDA's decision date was Jun 4, 2026, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the Respiratory Gating for Scanners (2.1)?

Varian Medical Systems, Inc., based in Palo Alto, CA, is the applicant of record for K253026.

How long did the K253026 review take?

FDA received the submission on Sep 19, 2025 and issued its decision on Jun 4, 2026, 258 days later.

← All decisions in June 2026