Mobile C-Arm
FDA 510(k) K893617 · Acoma Medical Imaging, Inc.
510(k) numberK893617
Submission
- Device name
- Mobile C-Arm
- Applicant
- Acoma Medical Imaging, Inc.
Wheeling, IL, US - Received
- May 10, 1989
- Decision date
- July 14, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
More from Ge Oec Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K981227 | Symphony 360 Remote Control TableJAA · Traditional | 06/30/1998SE |
| K981131 | Pathfinder Mobile C ArmOXO · Abbreviated | 06/26/1998SE |
| K963851 | Tilting Radiographic Table (Remote)IXR · Traditional | 01/23/1997SE |
| K944952 | Angiographic SystemIZI · Traditional | 02/17/1995SE |
| K941017 | F/C/W TubestandIYB · Traditional | 07/29/1994SE |
| K941004 | CTS SystemIYB · Traditional | 07/29/1994SE |
| K925598 | Buckymatic Automatic Chest Film ChangerKPX · Traditional | 02/01/1993SE |
| K921116 | PX-100 Portable X-Ray GeneratorIZL · Traditional | 10/05/1992SE |
| K921425 | SCD-105 and SCD-125 Capacitor Discharge Mobile X-RIZL · Traditional | 08/27/1992SE |
| K902637 | Futurus 2001 X-Ray GeneratorIZO · Traditional | 08/03/1990SE |
Questions and answers
When was Mobile C-Arm cleared by the FDA?
Mobile C-Arm (K893617) received a 510(k) decision of Substantially Equivalent on July 14, 1989, 65 days after the submission was received.
What is the product code of K893617?
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.