Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 Prime

FDA 510(k) K123603 · Ge Healthcare Surgery GE Oec Medical Systems, Inc.

Substantially Equivalent

510(k) numberK123603

Submission

Device name
Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 Prime
Applicant
Ge Healthcare Surgery GE Oec Medical Systems, Inc.
Salt Lake City, UT, US
Received
November 21, 2012
Decision date
May 17, 2013
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
K122234Oec 9900 EliteOWB · Special 08/16/2012SE
K120613Oec 9900 EliteOXO · Special 04/06/2012SE

Questions and answers

When was Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 Prime cleared by the FDA?

Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 Prime (K123603) received a 510(k) decision of Substantially Equivalent on May 17, 2013, 177 days after the submission was received.

What is the product code of K123603?

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.