510(k) K091374

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

K091374 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 ULTRASOUND". The FDA issued a decision of Substantially Equivalent on May 26, 2009. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Ge Medical Systems China Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2009
Date Received
May 11, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type