B6

FDA 510(k) K163429 · Beijing East Whale Imaging Technology Co., Ltd.

Substantially Equivalent

510(k) numberK163429

Submission

Device name
B6
Applicant
Beijing East Whale Imaging Technology Co., Ltd.
Beijing, CN
Received
December 7, 2016
Decision date
January 4, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1650
Specialty
Radiology

Fluoroscopy of the human body.

Other 510(k)s with product code OXO

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K253296Digital C-ARM with 3DOXO · Traditional Allengers Medical Systems Limited06/05/2026SE
K252579Orthoscan TAU MVP Mini C-Arm SystemOXO · Traditional Ziehm-Orthoscan, Inc.01/14/2026SE
K253269OEC One CFDOXO · Traditional Ge Hualun Medical Systems Co. , Ltd.11/26/2025SE
K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)OXO · Traditional Hefei Chimed Intelligent Machine Co., Ltd.11/06/2025SE
K250587Orthoscan TAU Mini C-ArmOXO · Special Ziehm-Orthoscan, Inc.07/02/2025SE
K243452Orthoscan VERSA Mini C-ArmOXO · Traditional Ziehm-Orthoscan, Inc.01/14/2025SE
K240828OEC One ASDOXO · Traditional Ge Hualun Medical Systems Co. , Ltd.12/27/2024SE
K233669Oec 3DOXO · Traditional Ge Oec Medical Systems, Inc.03/28/2024SE
K213113Orthoscan Tau Mini C-ArmOXO · Special Orthoscan, Inc.10/21/2021SE
K203346Oec 3DOXO · Traditional Ge Oec Medical Systems, Inc.03/05/2021SE

More from Ge Oec Medical Systems, Inc.

510(k)DeviceDecision
K160984MultiScan G-Arm SystemOXO · Traditional 07/20/2016SE
K160343SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic ScannerIYN · Traditional 04/07/2016SE
K151280MultiScan G-Arm SystemOXO · Special 09/30/2015SE
K141672Digiarc 100AU+OXO · Special 07/31/2014SE
K131423G-Arm Multiscan SystemOXO · Traditional 11/07/2013SE

Questions and answers

When was B6 cleared by the FDA?

B6 (K163429) received a 510(k) decision of Substantially Equivalent on January 4, 2017, 28 days after the submission was received.

What is the product code of K163429?

The FDA product code is OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1650.