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FDA 510(k)

GC85A

K-Number: K160997 · 2016-07-06

ApplicantSamsung Electronics Co., Ltd.
Decision Date2016-07-06
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GC85A is a medical device manufactured by Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2016-07-06 under approval number K160997. 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 GC85A?

GC85A is a medical device that received FDA 510(k) clearance on 2016-07-06. It is manufactured by Samsung Electronics Co., Ltd.. The 510(k) number is K160997.

When was GC85A approved by the FDA?

GC85A received FDA 510(k) clearance on 2016-07-06, under approval number K160997.

What company makes GC85A?

GC85A is manufactured by Samsung Electronics Co., Ltd..

What is the FDA product code for GC85A?

The FDA product code for GC85A is KPR.

Other Devices by Samsung Electronics Co., Ltd.

K163115GC70 K162278Digital Diagnostic Mobile X-ray System 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. 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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