OEC One ASD
FDA 510(k) K240828 · Ge Hualun Medical Systems Co. , Ltd.
510(k) numberK240828
Submission
- Device name
- OEC One ASD
- Applicant
- Ge Hualun Medical Systems Co. , Ltd.
Beijing, CN - Received
- March 26, 2024
- Decision date
- December 27, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code OXO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253296 | Digital C-ARM with 3DOXO · Traditional | Allengers Medical Systems Limited | 06/05/2026SE |
| K252579 | Orthoscan TAU MVP Mini C-Arm SystemOXO · Traditional | Ziehm-Orthoscan, Inc. | 01/14/2026SE |
| K253269 | OEC One CFDOXO · Traditional | Ge Hualun Medical Systems Co. , Ltd. | 11/26/2025SE |
| K251004 | Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)OXO · Traditional | Hefei Chimed Intelligent Machine Co., Ltd. | 11/06/2025SE |
| K250587 | Orthoscan TAU Mini C-ArmOXO · Special | Ziehm-Orthoscan, Inc. | 07/02/2025SE |
| K243452 | Orthoscan VERSA Mini C-ArmOXO · Traditional | Ziehm-Orthoscan, Inc. | 01/14/2025SE |
| K233669 | Oec 3DOXO · Traditional | Ge Oec Medical Systems, Inc. | 03/28/2024SE |
| K213113 | Orthoscan Tau Mini C-ArmOXO · Special | Orthoscan, Inc. | 10/21/2021SE |
| K203346 | Oec 3DOXO · Traditional | Ge Oec Medical Systems, Inc. | 03/05/2021SE |
| K192819 | OEC EliteOXO · Special | Ge Oec Medical Systems, Inc. | 11/08/2019SE |
More from Ge Oec Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253269 | OEC One CFDOXO · Traditional | 11/26/2025SE |
| K250788 | Definium Tempo SelectKPR · Traditional | 08/28/2025SE |
| K242678 | Definium Pace Select ETKPR · Special | 10/01/2024SE |
| K231892 | Definium Pace SelectKPR · Traditional | 09/12/2023SE |
| K191699 | Discovery XR656 HD with VolumeRadKPR · Traditional | 07/24/2019SE |
| K182626 | OEC OneOXO · Traditional | 11/16/2018SE |
| K173612 | Optima XR646 HDKPR · Special | 12/11/2017SE |
| K172700 | OEC OneOWB · Traditional | 11/09/2017SE |
| K172869 | Discovery XR656 HDKPR · Special | 10/20/2017SE |
| K171800 | OEC Elite MiniViewOXO · Special | 07/12/2017SE |
Questions and answers
When was OEC One ASD cleared by the FDA?
OEC One ASD (K240828) received a 510(k) decision of Substantially Equivalent on December 27, 2024, 276 days after the submission was received.
What is the product code of K240828?
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.