Cleared Traditional

syngo?.via protoNeo (Version VA20)

K173378 · Siemens Healthcare GmbH · Radiology
Nov 2017
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K173378 is an FDA 510(k) clearance for the syngo?.via protoNeo (Version VA20), a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Siemens Healthcare GmbH (Erlangen, DE). The FDA issued a Cleared decision on November 20, 2017, 21 days after receiving the submission on October 30, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K173378 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2017
Decision Date November 20, 2017
Days to Decision 21 days
Submission Type Traditional
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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