Discovery XR656 HD
K-Number: K172869 · 2017-10-20
ApplicantGe Hualun Medical Systems Co. , Ltd.
Decision Date2017-10-20
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Discovery XR656 HD is a medical device manufactured by Ge Hualun Medical Systems Co. , Ltd.. It received FDA 510(k) clearance on 2017-10-20 under approval number K172869. 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?
Discovery XR656 HD is a medical device that received FDA 510(k) clearance on 2017-10-20. It is manufactured by Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K172869.
When was Discovery XR656 HD approved by the FDA?
Discovery XR656 HD received FDA 510(k) clearance on 2017-10-20, under approval number K172869.
What company makes Discovery XR656 HD?
Discovery XR656 HD is manufactured by Ge Hualun Medical Systems Co. , Ltd..
What is the FDA product code for Discovery XR656 HD?
The FDA product code for Discovery XR656 HD is KPR.
Other Devices by Ge Hualun Medical Systems Co. , Ltd.
Related Devices (Code: KPR)
K163203Carestream DRX-EvolutionCarestream Health, Inc.
K163115GC70Samsung Electronics Co., Ltd.
K152813FS-500DDR Medical Radiographic X-Ray SystemOrich Medical Equipment (Tianjin) Co., Ltd.
K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.
K161937CuattroDRCuattro, LLC
K162224ArtPix Mobile EZ2GOCmt Medical Technologies, Ltd.
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.