Cleared Traditional

K083348 - IMAGE-ARENA APPLICATIONS

K083348 is an FDA 510(k) clearance for IMAGE-ARENA APPLICATIONS, 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 40-day FDA review.

K083348 · Tomtec Imaging Systems GmbH · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
40d
Days
Class 2
Risk

K083348 is an FDA 510(k) clearance for the IMAGE-ARENA APPLICATIONS. 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 December 23, 2008 after a review of 40 days - a notably fast clearance cycle.

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.

FDA 510(k) Submission Details - K083348

510(k) Number K083348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2008
Decision Date December 23, 2008
Days to Decision 40 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 107d · This submission: 40d
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 2293
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K083348.
MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK
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CARESTREAM PACS, MODEL CARESTREAM PACS VII
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CT BRAIN PERFUSION FOR ZIOSTATION
K083084 · Ziosoft, Inc. · Dec 2008
PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION
K083555 · Emsoma Co., Ltd. · Dec 2008
VISAGE PACS, VERSION 6.0/CS 3.1
K082269 · Visage Imaging, Inc. · Dec 2008
K083348 · IMAGE-ARENA APPLICATIONS
Download PDF FDA Summary Tomtec Imaging System…