510(k) K072952

GE ECHOPAC by General Electric Co. — Product Code LLZ

K072952 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "GE ECHOPAC". The FDA issued a decision of Substantially Equivalent on November 16, 2007. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. General Electric Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2007
Date Received
October 18, 2007
Clearance Type
Special
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