Cleared Special

syngo.via View&GO

K201477 · Siemens Healthcare GmbH · Radiology
Jul 2020
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K201477 is an FDA 510(k) clearance for the syngo.via View&GO, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Siemens Healthcare GmbH (Forchheim, DE). The FDA issued a Cleared decision on July 1, 2020, 28 days after receiving the submission on June 3, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K201477 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2020
Decision Date July 01, 2020
Days to Decision 28 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050

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