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FDA 510(k)

MultiScan G-Arm System

K-Number: K160984 · 2016-07-20

ApplicantBeijing East Whale Imaging Technology Co., Ltd.
Decision Date2016-07-20
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MultiScan G-Arm System is the device name listed in this FDA 510(k) record. The listed applicant is Beijing East Whale Imaging Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-07-20 under 510(k) number K160984. 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 MultiScan G-Arm System?

MultiScan G-Arm System is a medical device that received FDA 510(k) clearance on 2016-07-20. The listed applicant is Beijing East Whale Imaging Technology Co., Ltd.. The 510(k) number is K160984.

When did MultiScan G-Arm System receive FDA 510(k) clearance?

MultiScan G-Arm System received FDA 510(k) clearance on 2016-07-20, under 510(k) number K160984.

Who is the listed applicant for MultiScan G-Arm System?

The FDA 510(k) record lists Beijing East Whale Imaging Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MultiScan G-Arm System?

The FDA product code for MultiScan G-Arm System is OXO.

Other records listing Beijing East Whale Imaging Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K163429B6K160343SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner

Related Devices (Code: OXO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253296Digital C-ARM with 3DAllengers Medical Systems LimitedK252579Orthoscan 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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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