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FDA 510(k)

B6

K-Number: K163429 · 2017-01-04

ApplicantBeijing East Whale Imaging Technology Co., Ltd.
Decision Date2017-01-04
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

B6 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 2017-01-04 under 510(k) number K163429. 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 B6?

B6 is a medical device that received FDA 510(k) clearance on 2017-01-04. The listed applicant is Beijing East Whale Imaging Technology Co., Ltd.. The 510(k) number is K163429.

When did B6 receive FDA 510(k) clearance?

B6 received FDA 510(k) clearance on 2017-01-04, under 510(k) number K163429.

Who is the listed applicant for B6?

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 B6?

The FDA product code for B6 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.

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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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