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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 / May 2026 / K252563

510(k) cleared

Neurophet SCALE PET

Neurophet., Inc. · May 15, 2026 · K252563

FDA cleared the Neurophet SCALE PET from Neurophet., Inc. on May 15, 2026 under K252563, 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 Aug 14, 2025. The decision came 274 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Neurophet., Inc. has 2 other decisions in the tracker over the last 12 months: K261273 (Neurophet AQUA), K252496 (Neurophet AQUA AD Plus).

Questions & Answers

What did FDA clear under K252563?

K252563 is the FDA 510(k) for Neurophet SCALE PET, submitted by Neurophet., Inc.. FDA's decision date was May 15, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Neurophet SCALE PET?

Neurophet., Inc., based in Seoul, is the applicant of record for K252563.

How long did the K252563 review take?

FDA received the submission on Aug 14, 2025 and issued its decision on May 15, 2026, 274 days later.

← All decisions in May 2026

Sources