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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 / K251030

510(k) cleared

Sirona Advanced Imaging Suite

Sirona Medical · Oct 22, 2025 · K251030

FDA cleared the Sirona Advanced Imaging Suite from Sirona Medical on Oct 22, 2025 under K251030, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 3, 2025. The decision came 202 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Sirona Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251030?

K251030 is the FDA 510(k) for Sirona Advanced Imaging Suite, submitted by Sirona Medical. FDA's decision date was Oct 22, 2025, under product code LLZ (System, Image Processing, Radiological).

Who makes the Sirona Advanced Imaging Suite?

Sirona Medical, based in San Francisco, CA, is the applicant of record for K251030.

How long did the K251030 review take?

FDA received the submission on Apr 3, 2025 and issued its decision on Oct 22, 2025, 202 days later.

← All decisions in October 2025