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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 / July 2026 / K253835

510(k) cleared

Affinity

Hermes Medical Solutions AB · Jul 31, 2026 · K253835

FDA cleared the Affinity from Hermes Medical Solutions AB on Jul 31, 2026 under K253835, 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 Dec 1, 2025. The decision came 242 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Hermes Medical Solutions AB has one other decision in the tracker over the last 12 months: K252477 (Hybrid Viewer (00859873006240)).

Questions & Answers

What did FDA clear under K253835?

K253835 is the FDA 510(k) for Affinity, submitted by Hermes Medical Solutions AB. FDA's decision date was Jul 31, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Affinity?

Hermes Medical Solutions AB, based in Stockholm, is the applicant of record for K253835.

How long did the K253835 review take?

FDA received the submission on Dec 1, 2025 and issued its decision on Jul 31, 2026, 242 days later.

← All decisions in July 2026

Sources