Company profile

HistoSonics, Inc.

HistoSonics, Inc. has 1 AI-enabled medical device on the FDA list. The first decision was on May 29, 2026 and the most recent on May 29, 2026 (HistoSonics® Planning Tool). Its most common review panel is Radiology (1 device).

1AI devices

2026First decision

2026Latest decision

1Specialties

Timeline

May 29, 2026 · 510(k) K252947HistoSonics® Planning Tool · Radiology · QTZ