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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 / K261519

510(k) cleared

Sonio Suspect

Sonio · Jun 4, 2026 · K261519

FDA cleared the Sonio Suspect from Sonio on Jun 4, 2026 under K261519, a special 510(k). The device falls under product code POK, Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer, regulated at 21 CFR 892.2060 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 7, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Sonio has one other decision in the tracker over the last 12 months: K252433 (Sonio Detect (v3)).

Questions & Answers

What did FDA clear under K261519?

K261519 is the FDA 510(k) for Sonio Suspect, submitted by Sonio. FDA's decision date was Jun 4, 2026, under product code POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer).

Who makes the Sonio Suspect?

Sonio, based in Paris, is the applicant of record for K261519.

How long did the K261519 review take?

FDA received the submission on May 7, 2026 and issued its decision on Jun 4, 2026, 28 days later.

← All decisions in June 2026

Sources