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FDA 510(k)

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

K-Number: K170946 · 2017-11-24

ApplicantSkanray Technologies Private Limited
Decision Date2017-11-24
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Skanray Technologies Private Limited. The 510(k) number is K170946.

When was Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant approved by the FDA?

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 approval number K170946.

What company makes 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 manufactured by Skanray Technologies Private Limited.

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Skanray Technologies Private Limited

K152831Spot Skan K151512Star 60 K170967Intraskan DC Plus

Related Devices (Code: OXO)

K160984MultiScan G-Arm SystemBeijing East Whale Imaging Technology Co., Ltd. K160131OEC Elite MiniViewGe Hangwei Medical Systems Co., Ltd. K160065GEMSS Medical System Surgical Mobile Fluoroscopic X-ray SystemGemss Medical Systems Co., Ltd. K172550OEC EliteGe Oec Medical Systems, Inc. K171800OEC Elite MiniViewGe Hualun Medical Systems Co. , Ltd. K163429B6Beijing East Whale Imaging Technology Co., 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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