510(k) K071570

GE LUNAR BODY COMPOSITION SOFTWARE by Ge Medical Systems Lunar — Product Code KGI

K071570 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Lunar for the device "GE LUNAR BODY COMPOSITION SOFTWARE". The FDA issued a decision of Substantially Equivalent on June 27, 2007. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. Ge Medical Systems Lunar has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2007
Date Received
June 8, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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