Cleared Traditional

K053133 - SYNGO DYNAMICS, VERSION 5.0 (FDA 510(k) Clearance)

K053133 · Siemens Medical Solutions USA, Inc. · Radiology device

Dec 2005

Decision

27d

Days

Class 2

Risk

K053133 is an FDA 510(k) clearance for the SYNGO DYNAMICS, VERSION 5.0. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on December 5, 2005, 27 days after receiving the submission on November 8, 2005.

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

Submission Details

510(k) Number	K053133 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 08, 2005
Decision Date	December 05, 2005
Days to Decision	27 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF