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FDA 510(k)

GXR-Series Diagnostic X-Ray System

K-Number: K192364 · 2019-09-26

ApplicantDRGEM Corporation
Decision Date2019-09-26
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GXR-Series Diagnostic X-Ray System is a medical device manufactured by DRGEM Corporation. It received FDA 510(k) clearance on 2019-09-26 under approval number K192364. 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 GXR-Series Diagnostic X-Ray System?

GXR-Series Diagnostic X-Ray System is a medical device that received FDA 510(k) clearance on 2019-09-26. It is manufactured by DRGEM Corporation. The 510(k) number is K192364.

When was GXR-Series Diagnostic X-Ray System approved by the FDA?

GXR-Series Diagnostic X-Ray System received FDA 510(k) clearance on 2019-09-26, under approval number K192364.

What company makes GXR-Series Diagnostic X-Ray System?

GXR-Series Diagnostic X-Ray System is manufactured by DRGEM Corporation.

What is the FDA product code for GXR-Series Diagnostic X-Ray System?

The FDA product code for GXR-Series Diagnostic X-Ray System is KPR.

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Other Devices by DRGEM Corporation

K192453DIAMOND-5A/6A/8A K183292Topaz Mobile DR System K182537RADMAX Digital Imaging Software K183388JADE Mobile X-Ray K202572GXR-Series Diagnostic X-Ray System K202156DIAMOND-5A/6A/8A

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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.

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