FDA 510(k)

2D CARDIAC PERFORMANCE ANALYSIS MR 1.0

K-Number: K120135 · 2012-04-13

Decision Date2012-04-13

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 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 2012-04-13 under 510(k) number K120135. 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 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0?

2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 is a medical device that received FDA 510(k) clearance on 2012-04-13. The listed applicant is Tomtec Imaging Systems GmbH. The 510(k) number is K120135.

When did 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 receive FDA 510(k) clearance?

2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 received FDA 510(k) clearance on 2012-04-13, under 510(k) number K120135.

Who is the listed applicant for 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0?

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 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0?

The FDA product code for 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 is LLZ.

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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.