O-Arm Imaging System
FDA 510(k) K092564 · Medtronic Navigation, Inc. (Littleton)
510(k) numberK092564
Submission
- Device name
- O-Arm Imaging System
- Applicant
- Medtronic Navigation, Inc. (Littleton)
Littleton, MA, US - Received
- August 20, 2009
- Decision date
- June 17, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
| K240828 | OEC One ASDOXO · Traditional | Ge Hualun Medical Systems Co. , Ltd. | 12/27/2024SE |
| 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 |
Questions and answers
When was O-Arm Imaging System cleared by the FDA?
O-Arm Imaging System (K092564) received a 510(k) decision of Substantially Equivalent on June 17, 2010, 301 days after the submission was received.
What is the product code of K092564?
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.