Submission Details
| 510(k) Number | K251805 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 12, 2025 |
| Decision Date | October 15, 2025 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
syngo.CT Dual Energy
Oct 2025
Decision
125d
Days
Class 2
Risk
About This 510(k) Submission
K251805 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 October 15, 2025, 125 days after receiving the submission on June 12, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.
Device Classification
| Product Code | JAK — System, X-ray, Tomography, Computed |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1750 |
Manufacturer
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