510(k) K240705

Vitrea Software Package, VSTP-002A V2.0 by Canon Medical Systems Corporation — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2024
Date Received
March 14, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type