Cleared Abbreviated

syngo.via (Version VB40A)

K191040 · Siemens Healthcare GmbH · Radiology
May 2019
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K191040 is an FDA 510(k) clearance for the syngo.via (Version VB40A), 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 May 16, 2019, 27 days after receiving the submission on April 19, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K191040 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2019
Decision Date May 16, 2019
Days to Decision 27 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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