Cleared Traditional

Syngo Carbon Space VA30A

K230561 · Siemens Healthcare GmbH · Radiology
Mar 2023
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K230561 is an FDA 510(k) clearance for the Syngo Carbon Space VA30A, 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 March 21, 2023, 21 days after receiving the submission on February 28, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K230561 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2023
Decision Date March 21, 2023
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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