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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 / September 2025 / K252477

510(k) cleared

Hybrid Viewer (00859873006240)

Hermes Medical Solutions AB · Sep 9, 2025 · K252477

FDA cleared the Hybrid Viewer (00859873006240) from Hermes Medical Solutions AB on Sep 9, 2025 under K252477, a special 510(k). The device falls under product code KPS, System, Tomography, Computed, Emission, regulated at 21 CFR 892.1200 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Aug 7, 2025. The decision came 33 days later, inside the 90 FDA-day goal for a 510(k).

Hermes Medical Solutions AB has one other decision in the tracker over the last 12 months: K253835 (Affinity).

Questions & Answers

What did FDA clear under K252477?

K252477 is the FDA 510(k) for Hybrid Viewer (00859873006240), submitted by Hermes Medical Solutions AB. FDA's decision date was Sep 9, 2025, under product code KPS (System, Tomography, Computed, Emission).

Who makes the Hybrid Viewer (00859873006240)?

Hermes Medical Solutions AB, based in Stockholm, is the applicant of record for K252477.

How long did the K252477 review take?

FDA received the submission on Aug 7, 2025 and issued its decision on Sep 9, 2025, 33 days later.

← All decisions in September 2025

Sources