510(k) K102256

GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND by Ge Medical Systems China Co., Ltd. — Product Code IYN

K102256 is an FDA 510(k) premarket notification submitted by Ge Medical Systems China Co., Ltd. for the device "GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND". The FDA issued a decision of Substantially Equivalent on October 5, 2010. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Ge Medical Systems China Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2010
Date Received
August 10, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type