Cleared Traditional

Optima XR646

K143270 · Ge Hualun Medical Systems Co. , Ltd. · Radiology
Feb 2015
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K143270 is an FDA 510(k) clearance for the Optima XR646, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Ge Hualun Medical Systems Co. , Ltd. (Beijing, CN). The FDA issued a Cleared decision on February 18, 2015, 97 days after receiving the submission on November 13, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K143270 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2014
Decision Date February 18, 2015
Days to Decision 97 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPR — System, X-ray, Stationary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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