Cleared Traditional

syngo Virtual Cockpit (VB10A)

K232744 · Siemens Healthcare GmbH · Radiology
Dec 2023
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K232744 is an FDA 510(k) clearance for the syngo Virtual Cockpit (VB10A), a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Siemens Healthcare GmbH (Erlanger, DE). The FDA issued a Cleared decision on December 21, 2023, 105 days after receiving the submission on September 7, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K232744 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2023
Decision Date December 21, 2023
Days to Decision 105 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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