WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / May 2026 / K252954

510(k) cleared

MammoSightAI

Neurocareai, Inc. (Dba Savelife.Ai) · May 4, 2026 · K252954

FDA cleared the MammoSightAI from Neurocareai, Inc. (Dba Savelife.Ai) on May 4, 2026 under K252954, a traditional 510(k). The device falls under product code QFM, Radiological Computer-Assisted Prioritization Software For Lesions, regulated at 21 CFR 892.2080 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 16, 2025. The decision came 230 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: K260936 (RadioViewAI), K253751 (CXRDetectAI).

Questions & Answers

What did FDA clear under K252954?

K252954 is the FDA 510(k) for MammoSightAI, submitted by Neurocareai, Inc. (Dba Savelife.Ai). FDA's decision date was May 4, 2026, under product code QFM (Radiological Computer-Assisted Prioritization Software For Lesions).

Who makes the MammoSightAI?

Neurocareai, Inc. (Dba Savelife.Ai), based in Prosper, TX, is the applicant of record for K252954.

How long did the K252954 review take?

FDA received the submission on Sep 16, 2025 and issued its decision on May 4, 2026, 230 days later.

← All decisions in May 2026

Sources