510(k) · Radiology

TOMTEC-ARENA

by TOMTEC Imaging Systems GmbH

TOMTEC-ARENA is an AI-enabled medical device from TOMTEC Imaging Systems GmbH that the U.S. FDA cleared through 510(k) K201632 on August 14, 2020. Its lead review panel is Radiology and its primary product code is LLZ (System, Image Processing, Radiological).

See also FDA-cleared AI radiology devices in 2020, all FDA AI clearances in 2020, top radiology AI devices.

Key facts

Submission numberK201632
Pathway510(k)
Date of final decision
Company (FDA list)TOMTEC Imaging Systems GmbH
Lead review panelRadiology
Primary product codeLLZ — System, Image Processing, Radiological
Applicant (openFDA)Tomtec Imaging Systems GmbH
Applicant locationUnterschleissheim, DE
Device classClass 2
Regulation number21 CFR 892.2050
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. TOMTEC-ARENA went through this pathway (K201632).

openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.

Product code LLZ covers 161 devices on the FDA AI list. By decision date, this device is #75 of 161 under that code. TOMTEC Imaging Systems GmbH has 2 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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