510(k) K220433

syngo Application Software (VE21) by Siemens Medical Solution USA, Inc. — Product Code LLZ

K220433 is an FDA 510(k) premarket notification submitted by Siemens Medical Solution USA, Inc. for the device "syngo Application Software (VE21)". The FDA issued a decision of Substantially Equivalent on Aug 16, 2022. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Siemens Medical Solution USA, Inc. has 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 16, 2022
Date Received
Feb 15, 2022
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
510(k)