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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 / June 2026 / K253264

510(k) cleared

myAblation Guide (VC10A)

Siemens Healthcare GmbH · Jun 16, 2026 · K253264

FDA cleared the myAblation Guide (VC10A) from Siemens Healthcare GmbH on Jun 16, 2026 under K253264, a traditional 510(k). The device falls under product code QTZ, Radiological Image Processing Software For Ablation Therapy Planning And Evaluation, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 29, 2025. The decision came 260 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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)), P250026 (Atellica IM free PSA II (fPSAII)).

Questions & Answers

What did FDA clear under K253264?

K253264 is the FDA 510(k) for myAblation Guide (VC10A), submitted by Siemens Healthcare GmbH. FDA's decision date was Jun 16, 2026, under product code QTZ (Radiological Image Processing Software For Ablation Therapy Planning And Evaluation).

Who makes the myAblation Guide (VC10A)?

Siemens Healthcare GmbH, based in Erlanger, is the applicant of record for K253264.

How long did the K253264 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jun 16, 2026, 260 days later.

← All decisions in June 2026