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FDA 510(k)

GC70

K-Number: K163115 · 2016-12-07

ApplicantSamsung Electronics Co., Ltd.
Decision Date2016-12-07
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GC70 is a medical device manufactured by Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2016-12-07 under approval number K163115. 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 GC70?

GC70 is a medical device that received FDA 510(k) clearance on 2016-12-07. It is manufactured by Samsung Electronics Co., Ltd.. The 510(k) number is K163115.

When was GC70 approved by the FDA?

GC70 received FDA 510(k) clearance on 2016-12-07, under approval number K163115.

What company makes GC70?

GC70 is manufactured by Samsung Electronics Co., Ltd..

What is the FDA product code for GC70?

The FDA product code for GC70 is KPR.

Other Devices by Samsung Electronics Co., Ltd.

K162278Digital Diagnostic Mobile X-ray System K160997GC85A K172229GC85A K171119GM85 K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A K182647GC70

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Related Devices (Code: KPR)

K163203Carestream DRX-EvolutionCarestream Health, Inc. 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. K152294FDR Visionary SuiteShimadzu Corporation

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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