Cleared Traditional

K060992 - SYNGO US WORKPLACE (FDA 510(k) Clearance)

K060992 · Siemens Medical Solutions · Radiology device

Apr 2006

Decision

17d

Days

Class 2

Risk

K060992 is an FDA 510(k) clearance for the SYNGO US WORKPLACE. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Siemens Medical Solutions (Mountainview, US). The FDA issued a Cleared decision on April 28, 2006, 17 days after receiving the submission on April 11, 2006.

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

Submission Details

510(k) Number	K060992 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 11, 2006
Decision Date	April 28, 2006
Days to Decision	17 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF