Cleared Traditional

Syngo Carbon Space VA20A

K213665 · Siemens Healthcare GmbH · Radiology
Jun 2022
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K213665 is an FDA 510(k) clearance for the Syngo Carbon Space VA20A, 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 June 21, 2022, 211 days after receiving the submission on November 22, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K213665 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2021
Decision Date June 21, 2022
Days to Decision 211 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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