510(k) K071114

SYNGO IMAGING (VERSION V30) by Siemens AG Medical Solutions — Product Code LLZ

K071114 is an FDA 510(k) premarket notification submitted by Siemens AG Medical Solutions for the device "SYNGO IMAGING (VERSION V30)". The FDA issued a decision of Substantially Equivalent on May 22, 2007. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Siemens AG Medical Solutions has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2007
Date Received
April 20, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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