Discovery XR656 HD with VolumeRad
K-Number: K191699 · 2019-07-24
ApplicantGe Hualun Medical Systems Co. , Ltd.
Decision Date2019-07-24
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Discovery XR656 HD with VolumeRad is a medical device manufactured by Ge Hualun Medical Systems Co. , Ltd.. It received FDA 510(k) clearance on 2019-07-24 under approval number K191699. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Discovery XR656 HD with VolumeRad?
Discovery XR656 HD with VolumeRad is a medical device that received FDA 510(k) clearance on 2019-07-24. It is manufactured by Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K191699.
When was Discovery XR656 HD with VolumeRad approved by the FDA?
Discovery XR656 HD with VolumeRad received FDA 510(k) clearance on 2019-07-24, under approval number K191699.
What company makes Discovery XR656 HD with VolumeRad?
Discovery XR656 HD with VolumeRad is manufactured by Ge Hualun Medical Systems Co. , Ltd..
What is the FDA product code for Discovery XR656 HD with VolumeRad?
The FDA product code for Discovery XR656 HD with VolumeRad is KPR.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.