510(k) K232136

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

K232136 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "syngo.CT Applications". The FDA issued a decision of Substantially Equivalent on January 4, 2024. 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 4, 2024
Date Received
July 18, 2023
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