510(k) K103730

GE LUNAR VISCERAL FAT SOFTWARE by Ge Medical Systems Ultrasound and Primary Care Dia — Product Code KGI

K103730 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Ultrasound and Primary Care Dia for the device "GE LUNAR VISCERAL FAT SOFTWARE". The FDA issued a decision of Substantially Equivalent on May 6, 2011. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. Ge Medical Systems Ultrasound and Primary Care Dia has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2011
Date Received
December 21, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Densitometer, Bone
Device Class
Class II
Regulation Number
892.1170
Review Panel
RA
Submission Type