Cleared Traditional

GEHC DXA Bone Densitometers with enCORE version 18

K191112 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Radiology

Sep 2019

Decision

146d

Days

Class 2

Risk

About This 510(k) Submission

K191112 is an FDA 510(k) clearance for the GEHC DXA Bone Densitometers with enCORE version 18, 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 September 19, 2019, 146 days after receiving the submission on April 26, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1170.

Submission Details

510(k) Number	K191112 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 26, 2019
Decision Date	September 19, 2019
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF