510(k) · Cleared
Recalled · Class II · 2016Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 Prime
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Healthcare Surgery GE Oec Medical Systems, Inc. · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on May 17, 2013 as substantially equivalent to K111551 (Ge Oec Medical Systems, Inc., 2011) after a 177-day review. Its family tree reaches back 5 generations to 2002. 2 of the 11 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 5 times.
- Decided
- May 17, 2013
- Review
- 177 days
- Class
- Class II
- Product code
- OXO
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 5 generations to K021049 (2002). 6 ancestors in all. 4 later devices descend from it, 1 citing it directly. 2 of the 11 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK021049 Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Recalled (Class I)
- 4 generations backK041932 Oec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc. · 2004 · Recalled
- 3 generations backK073543 Oec 9900 EliteGe Oec Medical Systems · 2008 · Recalled
- 2 generations backK082781 Oec 9900 EliteGe Healthcare Surgery · 2009 · Recalled
- 1 generation backK111551 Oec (R) 9800, Oec (R) 9800 PlusGe Oec Medical Systems, Inc. · 2011 · Recalled
- This deviceK123603 Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715…Ge Healthcare Surgery GE Oec Medical Systems, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK172700 OEC OneGe Hualun Medical Systems Co., Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK182626 OEC OneGe Hualun Medical Systems Co., Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK240828 OEC One ASDGe Hualun Medical Systems Co., Ltd. · 2024
- Descendant · 4 generations on · 0 of its ownK253269 OEC One CFDGe Hualun Medical Systems Co., Ltd. · 2025
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K172700OEC OneGe Hualun Medical Systems Co., Ltd. · 2017 · cites it directly3descendants
- K182626OEC OneGe Hualun Medical Systems Co., Ltd. · 2018 · 2 generations on2descendants
- K240828OEC One ASDGe Hualun Medical Systems Co., Ltd. · 2024 · 3 generations on1descendant
- K253269OEC One CFDGe Hualun Medical Systems Co., Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K021049 | Oec 9800 Plus Digital Mobile Imaging System | Ge Oec Medical Systems | 2002 | Class I |
| −4 | K041932 | Oec Olympus Fluoroscopic Imaging System | Ge Oec Medical Systems, Inc. | 2004 | 7 |
| −3 | K073543 | Oec 9900 Elite | Ge Oec Medical Systems | 2008 | 5 |
| −2 | K082781 | Oec 9900 Elite | Ge Healthcare Surgery | 2009 | 4 |
| −1 | K111551 | Oec (R) 9800, Oec (R) 9800 Plus | Ge Oec Medical Systems, Inc. | 2011 | 9 |
| 0 (this device) | K123603 | Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 Prime | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2013 | — |
| +1 | K172700 | OEC One | Ge Hualun Medical Systems Co., Ltd. | 2017 | — |
| +2 | K182626 | OEC One | Ge Hualun Medical Systems Co., Ltd. | 2018 | — |
| +3 | K240828 | OEC One ASD | Ge Hualun Medical Systems Co., Ltd. | 2024 | — |
| +4 | K253269 | OEC One CFD | Ge Hualun Medical Systems Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OXO device
- #1 K253296 Digital C-ARM with 3Dscore 15.1 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111551 | Oec (R) 9800, Oec (R) 9800 PlusSummary page 1…stem Classification Names: 21 CFR 892.1650 Image-intensified fluoroscopic x-ray system Product Code: 900X0, 9OJAA Predicate Device(s): K 111551 OEC® 9800 / OEC® 9800 Plus Device Description: The OEC®' Brivo®o is a system used to assist trained… | 2011 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172700 | OEC One | 2017 | 3 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2016 | Class II | Z-0071-2017 | Nonconforming Material/Component | GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls vertical motion of the C-arm may fail, resulting in the C-Arm… |
| Sep 15, 2014 | Class II | Z-0840-2015 | Radiation Control for Health and Safety Act | mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in… |
| Sep 15, 2014 | Class II | Z-0841-2015 | Radiation Control for Health and Safety Act | mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in… |
| May 22, 2014 | Class II | Z-1638-2015 | Radiation Control for Health and Safety Act | Laser aimer assemblies were shipped without certification of the overall assembly or submitting a laser product report and therefore do not comply with the US regulations for laser products. |
| Sep 18, 2013 | Class II | Z-0066-2014 | Device Design | GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires in the high voltage cable bundle to fail, resulting in loss of system functionality. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K024012Oec 9800 E/CV+ Digital Mobile Imaging SystemGe Oec Medical Systems · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 6 of the 6 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K172700 (Ge Hualun Medical Systems Co., Ltd., 2017) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K111551.
How does its category compare?
All OXO devicesOXO Image-Intensified Fluoroscopic X-Ray System, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OXO
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OXO
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OXO
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OXO
118in 2025
MAUDE reports naming product code OXO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 48 | 4 | 5 |
| 2013 | 2 | — | 3 | 41 |
| 2014 | 2 | — | 4 | 89 |
| 2015 | 1 | — | 0 | 97 |
| 2016 | 3 | 128 | 3 | 3,820 |
| 2017 | 4 | 57 | 4 | 1,697 |
| 2018 | 1 | — | 11 | 1,647 |
| 2019 | 3 | 213 | 0 | 1,297 |
| 2020 | 0 | — | 0 | 816 |
| 2021 | 2 | — | 0 | 554 |
| 2022 | 0 | — | 0 | 295 |
| 2023 | 0 | — | 0 | 275 |
| 2024 | 2 | — | 4 | 192 |
| 2025 | 4 | 97 | 0 | 118 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The OEC® Brivo® Mobile C-Arm X-Ray Products are designed to provide digital spot-film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localization/s or needle positions for aspirations, injections or biopsy. The OEC® Brivo® is not indicated for interventional use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123603 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123603: Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 Prime.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123603
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026