510(k) K131498

IQQA-LIVER MULTIMODALITY SOFTWARE by Edda Technology, Inc. — Product Code LLZ

K131498 is an FDA 510(k) premarket notification submitted by Edda Technology, Inc. for the device "IQQA-LIVER MULTIMODALITY SOFTWARE". The FDA issued a decision of Substantially Equivalent on July 25, 2013. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Edda Technology, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2013
Date Received
May 24, 2013
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