Cleared Special

Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family

K243186 · Siemens Medical Solutions USA, Inc. · Radiology
Oct 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K243186 is an FDA 510(k) clearance for the Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by Siemens Medical Solutions USA, Inc. (Knoxville, US). The FDA issued a Cleared decision on October 30, 2024, 30 days after receiving the submission on September 30, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K243186 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2024
Decision Date October 30, 2024
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPS — System, Tomography, Computed, Emission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1200

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