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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 / September 2025 / K244002

510(k) cleared

AngioWaveNet

Angiowave Imaging, Inc. · Sep 10, 2025 · K244002

FDA cleared the AngioWaveNet from Angiowave Imaging, Inc. on Sep 10, 2025 under K244002, 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 26, 2024. The decision came 258 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 Angiowave Imaging, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K244002?

K244002 is the FDA 510(k) for AngioWaveNet, submitted by Angiowave Imaging, Inc.. FDA's decision date was Sep 10, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the AngioWaveNet?

Angiowave Imaging, Inc., based in Concord, MA, is the applicant of record for K244002.

How long did the K244002 review take?

FDA received the submission on Dec 26, 2024 and issued its decision on Sep 10, 2025, 258 days later.

← All decisions in September 2025