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FDA 510(k)

GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A

K-Number: K182183 · 2018-12-07

ApplicantSamsung Electronics Co., Ltd.
Decision Date2018-12-07
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A is a medical device manufactured by Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2018-12-07 under approval number K182183. 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, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A?

GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A is a medical device that received FDA 510(k) clearance on 2018-12-07. It is manufactured by Samsung Electronics Co., Ltd.. The 510(k) number is K182183.

When was GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A approved by the FDA?

GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A received FDA 510(k) clearance on 2018-12-07, under approval number K182183.

What company makes GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A?

GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A is manufactured by Samsung Electronics Co., Ltd..

What is the FDA product code for GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A?

The FDA product code for GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A is KPR.

Other Devices by Samsung Electronics Co., Ltd.

K163115GC70 K162278Digital Diagnostic Mobile X-ray System K160997GC85A K172229GC85A K171119GM85 K182647GC70

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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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