Cleared Traditional

K102150 - SYNGO DYNAMICS, VERSION 9.0 (FDA 510(k) Clearance)

K102150 · Siemens Medical Solutions USA, Inc. · Radiology device

Oct 2010

Decision

68d

Days

Class 2

Risk

K102150 is an FDA 510(k) clearance for the SYNGO DYNAMICS, VERSION 9.0. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Siemens Medical Solutions USA, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on October 5, 2010, 68 days after receiving the submission on July 29, 2010.

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

Submission Details

510(k) Number	K102150 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 29, 2010
Decision Date	October 05, 2010
Days to Decision	68 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF