Cleared Traditional

GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION

K082317 · General Electric Co. · Radiology
Sep 2008
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K082317 is an FDA 510(k) clearance for the GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION, a Densitometer, Bone (Class II — Special Controls, product code KGI), submitted by General Electric Co. (Madison, US). The FDA issued a Cleared decision on September 26, 2008, 44 days after receiving the submission on August 13, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1170.

Submission Details

510(k) Number K082317 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2008
Decision Date September 26, 2008
Days to Decision 44 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KGI — Densitometer, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1170