Cleared Traditional

Aria

K180782 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Radiology
Apr 2018
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K180782 is an FDA 510(k) clearance for the Aria, 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 April 20, 2018, 25 days after receiving the submission on March 26, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1170.

Submission Details

510(k) Number K180782 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2018
Decision Date April 20, 2018
Days to Decision 25 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