Cleared Traditional

syngo.via View&GO

K221501 · Siemens Healthcare GmbH · Radiology
Oct 2022
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K221501 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 (Erlangen, DE). The FDA issued a Cleared decision on October 14, 2022, 144 days after receiving the submission on May 23, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K221501 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2022
Decision Date October 14, 2022
Days to Decision 144 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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