Cleared Special

Optima XR646 HD

K173612 · Ge Hualun Medical Systems Co. , Ltd. · Radiology
Dec 2017
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K173612 is an FDA 510(k) clearance for the Optima XR646 HD, 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 December 11, 2017, 19 days after receiving the submission on November 22, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K173612 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2017
Decision Date December 11, 2017
Days to Decision 19 days
Submission Type Special
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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