Cleared Traditional

K230955 - syngo Application Software (FDA 510(k) Clearance)

K230955 · Siemens Medical Solutions USA, Inc. · Radiology device

Dec 2023

Decision

260d

Days

Class 2

Risk

K230955 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 Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on December 20, 2023, 260 days after receiving the submission on April 4, 2023.

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

Submission Details

510(k) Number	K230955 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 04, 2023
Decision Date	December 20, 2023
Days to Decision	260 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF