Cleared Traditional

K071950 - SYNGO TRUED (FDA 510(k) Clearance)

K071950 · Siemens Medical Solutions USA, Inc. · Radiology device

Jul 2007

Decision

11d

Days

Class 2

Risk

K071950 is an FDA 510(k) clearance for the SYNGO TRUED. 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 July 27, 2007, 11 days after receiving the submission on July 16, 2007.

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

Submission Details

510(k) Number	K071950 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 16, 2007
Decision Date	July 27, 2007
Days to Decision	11 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF