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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 / K260936

510(k) cleared

RadioViewAI

Neurocareai, Inc. (Dba Savelife.Ai) · Jul 31, 2026 · K260936

FDA cleared the RadioViewAI from Neurocareai, Inc. (Dba Savelife.Ai) on Jul 31, 2026 under K260936, 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 Mar 20, 2026. The decision came 133 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Neurocareai, Inc. (Dba Savelife.Ai) has 2 other decisions in the tracker over the last 12 months: K253751 (CXRDetectAI), K252954 (MammoSightAI).

Questions & Answers

What did FDA clear under K260936?

K260936 is the FDA 510(k) for RadioViewAI, submitted by Neurocareai, Inc. (Dba Savelife.Ai). FDA's decision date was Jul 31, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the RadioViewAI?

Neurocareai, Inc. (Dba Savelife.Ai), based in Prosper, TX, is the applicant of record for K260936.

How long did the K260936 review take?

FDA received the submission on Mar 20, 2026 and issued its decision on Jul 31, 2026, 133 days later.

← All decisions in July 2026

Sources