Cleared Abbreviated

syngo.via View&GO (Version VA10A)

K182208 · Siemens Healthcare GmbH · Radiology
Sep 2018
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K182208 is an FDA 510(k) clearance for the syngo.via View&GO (Version VA10A), 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 September 7, 2018, 23 days after receiving the submission on August 15, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K182208 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2018
Decision Date September 07, 2018
Days to Decision 23 days
Submission Type Abbreviated
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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