510(k) K241757

syngo.CT Dual Energy by Siemens Medical Solutions USA, Inc. — Product Code JAK

K241757 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "syngo.CT Dual Energy". The FDA issued a decision of Substantially Equivalent on January 3, 2025. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2025
Date Received
June 18, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type