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FDA 510(k)

IMAGE-COM 5.0

K-Number: K122289 · 2012-10-24

ApplicantTomtec Imaging Systems GmbH
Decision Date2012-10-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGE-COM 5.0 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 2012-10-24 under 510(k) number K122289. 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-COM 5.0?

IMAGE-COM 5.0 is a medical device that received FDA 510(k) clearance on 2012-10-24. The listed applicant is Tomtec Imaging Systems GmbH. The 510(k) number is K122289.

When did IMAGE-COM 5.0 receive FDA 510(k) clearance?

IMAGE-COM 5.0 received FDA 510(k) clearance on 2012-10-24, under 510(k) number K122289.

Who is the listed applicant for IMAGE-COM 5.0?

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-COM 5.0?

The FDA product code for IMAGE-COM 5.0 is LLZ.

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Other records listing Tomtec Imaging Systems GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213544TOMTEC-ARENAK201632TOMTEC-ARENAK132544TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENAK1201352D CARDIAC PERFORMANCE ANALYSIS MR 1.0K1107464D LV-ANALYSIS 3.0K110667IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS

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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.

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