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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 / K252947

510(k) cleared

HistoSonics® Planning Tool

HistoSonics, Inc. · May 29, 2026 · K252947 · In the directory

FDA cleared the HistoSonics® Planning Tool from HistoSonics, Inc. on May 29, 2026 under K252947, a traditional 510(k). The device falls under product code QTZ, Radiological Image Processing Software For Ablation Therapy Planning And Evaluation, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 15, 2025. The decision came 256 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 HistoSonics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252947?

K252947 is the FDA 510(k) for HistoSonics® Planning Tool, submitted by HistoSonics, Inc.. FDA's decision date was May 29, 2026, under product code QTZ (Radiological Image Processing Software For Ablation Therapy Planning And Evaluation).

Who makes the HistoSonics® Planning Tool?

HistoSonics, Inc., based in Plymouth, MN, is the applicant of record for K252947. The company is listed in the MedDevice Startups directory.

How long did the K252947 review take?

FDA received the submission on Sep 15, 2025 and issued its decision on May 29, 2026, 256 days later.

← All decisions in May 2026

Sources

In the startup directory

HistoSonics

Oncology · Minneapolis, MN