Cleared Traditional

K120135 - 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 (FDA 510(k) Clearance)

K120135 · Tomtec Imaging Systems GmbH · Radiology device

Apr 2012

Decision

87d

Days

Class 2

Risk

K120135 is an FDA 510(k) clearance for the 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Tomtec Imaging Systems GmbH (Unterschleissheim, DE). The FDA issued a Cleared decision on April 13, 2012, 87 days after receiving the submission on January 17, 2012.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K120135 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 17, 2012
Decision Date	April 13, 2012
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF