Cleared Traditional

Discovery XR656 HD with VolumeRad

K191699 · Ge Hualun Medical Systems Co. , Ltd. · Radiology
Jul 2019
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K191699 is an FDA 510(k) clearance for the Discovery XR656 HD with VolumeRad, 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 July 24, 2019, 29 days after receiving the submission on June 25, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K191699 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2019
Decision Date July 24, 2019
Days to Decision 29 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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