Cleared Traditional

K190780 - syngo Application Software (FDA 510(k) Clearance)

K190780 · Siemens Medical Solution USA, Inc. · Radiology device

Sep 2019

Decision

169d

Days

Class 2

Risk

K190780 is an FDA 510(k) clearance for the syngo Application Software. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Siemens Medical Solution USA, Inc. (Malvern, US). The FDA issued a Cleared decision on September 12, 2019, 169 days after receiving the submission on March 27, 2019.

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

Submission Details

510(k) Number	K190780 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 27, 2019
Decision Date	September 12, 2019
Days to Decision	169 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF