Cleared Traditional

K161682 - GE Lunar DXA Bone Densitometers with enCORE version 17
(FDA 510(k) Clearance)

K161682 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Radiology
Dec 2016
Decision
168d
Days
Class 2
Risk

K161682 is an FDA 510(k) clearance for the GE Lunar DXA Bone Densitometers with enCORE version 17, a Densitometer, Bone (Class II — Special Controls, product code KGI), submitted by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (Madison, US). The FDA issued a Cleared decision on December 2, 2016, 168 days after receiving the submission on June 17, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1170.

Submission Details

510(k) Number K161682 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2016
Decision Date December 02, 2016
Days to Decision 168 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