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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 / April 2026 / K253689

510(k) cleared

syngo Dynamics (VA41F)

Siemens Healthcare GmbH · Apr 10, 2026 · K253689

FDA cleared the syngo Dynamics (VA41F) from Siemens Healthcare GmbH on Apr 10, 2026 under K253689, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 21, 2025. The decision came 140 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)), K253264 (myAblation Guide (VC10A)).

Questions & Answers

What did FDA clear under K253689?

K253689 is the FDA 510(k) for syngo Dynamics (VA41F), submitted by Siemens Healthcare GmbH. FDA's decision date was Apr 10, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the syngo Dynamics (VA41F)?

Siemens Healthcare GmbH, based in Erlanger, is the applicant of record for K253689.

How long did the K253689 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Apr 10, 2026, 140 days later.

← All decisions in April 2026