Cleared Traditional

K132544 - TOMTEC-ARENA 1.0

K132544 is an FDA 510(k) clearance for TOMTEC-ARENA 1.0, manufactured by Tomtec Imaging Systems GmbH. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K132544 · Tomtec Imaging Systems GmbH · Radiology device
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Nov 2013
Decision
104d
Days
Class 2
Risk

K132544 is an FDA 510(k) clearance for the TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Tomtec Imaging Systems GmbH (Unterschleissheim, DE). The FDA issued a Cleared decision on November 25, 2013 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Tomtec Imaging Systems GmbH devices

FDA 510(k) Submission Details - K132544

510(k) Number K132544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2013
Decision Date November 25, 2013
Days to Decision 104 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 107d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1205
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