FDA 510(k)

IMAGE-ARENA APPLICATIONS

K-Number: K083348 · 2008-12-23

Decision Date2008-12-23

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

IMAGE-ARENA APPLICATIONS is the device name listed in this FDA 510(k) record. The listed applicant is Tomtec Imaging Systems GmbH. It received FDA 510(k) clearance on 2008-12-23 under 510(k) number K083348. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGE-ARENA APPLICATIONS?

IMAGE-ARENA APPLICATIONS is a medical device that received FDA 510(k) clearance on 2008-12-23. The listed applicant is Tomtec Imaging Systems GmbH. The 510(k) number is K083348.

When did IMAGE-ARENA APPLICATIONS receive FDA 510(k) clearance?

IMAGE-ARENA APPLICATIONS received FDA 510(k) clearance on 2008-12-23, under 510(k) number K083348.

Who is the listed applicant for IMAGE-ARENA APPLICATIONS?

The FDA 510(k) record lists Tomtec Imaging Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMAGE-ARENA APPLICATIONS?

The FDA product code for IMAGE-ARENA APPLICATIONS is LLZ.

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Other records listing Tomtec Imaging Systems GmbH as applicant

K213544TOMTEC-ARENA K201632TOMTEC-ARENA K132544TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA K122289IMAGE-COM 5.0 K1201352D CARDIAC PERFORMANCE ANALYSIS MR 1.0 K1107464D LV-ANALYSIS 3.0

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.