FDA 510(k)

Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant

N.º K: K170946 · 2017-11-24

SolicitanteSkanray Technologies Private Limited

Fecha de decisión2017-11-24

Código de productoOXO

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant is the device name listed in this FDA 510(k) record. The listed applicant is Skanray Technologies Private Limited. It received FDA 510(k) clearance on 2017-11-24 under 510(k) number K170946. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant?

Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant is a medical device that received FDA 510(k) clearance on 2017-11-24. The listed applicant is Skanray Technologies Private Limited. The 510(k) number is K170946.

When did Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant receive FDA 510(k) clearance?

Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant received FDA 510(k) clearance on 2017-11-24, under 510(k) number K170946.

Who is the listed applicant for Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant?

The FDA 510(k) record lists Skanray Technologies Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant?

The FDA product code for Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant is OXO.

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Otros registros que enlistan a Skanray Technologies Private Limited como solicitante

K170967Intraskan DC Plus K152831Spot Skan K151512Star 60

Dispositivos relacionados (Código: OXO)

K253296Digital C-ARM with 3DAllengers Medical Systems Limited K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.K253269OEC One CFDGe Hualun Medical Systems Co. , Ltd.K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)Hefei Chimed Intelligent Machine Co., Ltd.K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc.K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, Inc.

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.