Company profile

TOMTEC Imaging Systems GmbH

TOMTEC Imaging Systems GmbH has 2 AI-enabled medical devices on the FDA list. The first decision was on August 14, 2020 and the most recent on January 6, 2022 (TOMTEC-ARENA). Its most common review panel is Radiology (2 devices).

2AI devices

2020First decision

2022Latest decision

1Specialties

Related guides

Top radiology devices

Timeline

January 6, 2022 · 510(k) K213544TOMTEC-ARENA · Radiology · QIH
August 14, 2020 · 510(k) K201632TOMTEC-ARENA · Radiology · LLZ