Cleared Traditional

syngo.CT Dual Energy

K241757 · Siemens Medical Solutions USA, Inc. · Radiology
Jan 2025
Decision
199d
Days
Class 2
Risk

About This 510(k) Submission

K241757 is an FDA 510(k) clearance for the syngo.CT Dual Energy, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Siemens Medical Solutions USA, Inc. (Knoxville, US). The FDA issued a Cleared decision on January 3, 2025, 199 days after receiving the submission on June 18, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K241757 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 2024
Decision Date January 03, 2025
Days to Decision 199 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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