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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 / April 2026 / K252190

510(k) cleared

DeepBT Detector-Plus

Aitewan Biomedical Technology, Inc. · Apr 10, 2026 · K252190

FDA cleared the DeepBT Detector-Plus from Aitewan Biomedical Technology, Inc. on Apr 10, 2026 under K252190, a traditional 510(k). The device falls under product code QKB, Radiological Image Processing Software For Radiation Therapy, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 14, 2025. The decision came 270 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Aitewan Biomedical Technology, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252190?

K252190 is the FDA 510(k) for DeepBT Detector-Plus, submitted by Aitewan Biomedical Technology, Inc.. FDA's decision date was Apr 10, 2026, under product code QKB (Radiological Image Processing Software For Radiation Therapy).

Who makes the DeepBT Detector-Plus?

Aitewan Biomedical Technology, Inc., based in Taipei, is the applicant of record for K252190.

How long did the K252190 review take?

FDA received the submission on Jul 14, 2025 and issued its decision on Apr 10, 2026, 270 days later.

← All decisions in April 2026