Gc70, Gu60a, Gu60a-65, Gf50, Gr50a +3 more models

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K182183

Identifiers

510(k) Number: K182183 FDA 510(k)
FDA Product Code: KPR FDA 510(k)
Models / Variants: Gc70, Gu60a, Gu60a-65, Gf50, Gr50a FDA 510(k)EUDAMED
Gr40cw FDA 510(k)EUDAMED
Gm85 FDA 510(k)EUDAMED
Gc85a FDA 510(k)EUDAMED

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 892.1680 FDA 510(k)
Regulation Number: 892.1680 FDA 510(k)
Advisory Committee: Radiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

This is a stationary X-ray system designed for radiologic imaging. The devices fall under the category of diagnostic X-ray systems, providing high-resolution imaging for medical diagnostics in radiology settings. They are configured for various imaging applications, including general radiography and specialized procedures requiring precise imaging capabilities.

The GC70, GU60A, GU60A-65, GF50, GR50A, GR40CW, GM85, and GC85A are supplied as stationary X-ray systems intended for clinical use. These devices are classified as Class II under FDA regulations and have received FDA 510(k) clearance and EU MDR authorization. They are not single-use items and are intended for installation in controlled medical environments, adhering to standard safety and sterility protocols for radiographic equipment.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K182183	Class II	Active

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Manufacturer

Manufacturer: Samsung Electronics Co., Ltd.

Sources (2)

FDA 510(k) K182183 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced May 19, 2026