Cleared Traditional

K110595 - 4D SONO-SCAN 1.0 (FDA 510(k) Clearance)

K110595 · Tomtec Imaging Systems GmbH · Radiology device

Apr 2011

Decision

36d

Days

Class 2

Risk

K110595 is an FDA 510(k) clearance for the 4D SONO-SCAN 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 7, 2011, 36 days after receiving the submission on March 2, 2011.

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

Submission Details

510(k) Number	K110595 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 02, 2011
Decision Date	April 07, 2011
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF