Cleared Traditional

syngo.via View&GO VA40A

K230196 · Siemens Healthcare GmbH · Radiology
Feb 2023
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K230196 is an FDA 510(k) clearance for the syngo.via View&GO VA40A, 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 February 13, 2023, 19 days after receiving the submission on January 25, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K230196 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2023
Decision Date February 13, 2023
Days to Decision 19 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

More from Siemens Healthcare GmbH

View all
AI-Rad Companion Brain MR
K253057 · QIH · Jan 2026
MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise
K252838 · LNH · Dec 2025
AI-Rad Companion Prostate MR
K252608 · LLZ · Sep 2025
MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
K250443 · LNH · Jun 2025
syngo Dynamics (Version VA41D)
K242551 · QIH · Apr 2025