Company profile

Agada Medical, Ltd.

Agada Medical, Ltd. has 1 AI-enabled medical device on the FDA list. The first decision was on June 29, 2026 and the most recent on June 29, 2026 (Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)). Its most common review panel is Radiology (1 device).

1AI devices

2026First decision

2026Latest decision

1Specialties

Timeline

June 29, 2026 · 510(k) K253628Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) · Radiology · QIH