Mini 6800 Digital Mobile C-Arm
FDA 510(k) K992506 · Ge Dec Medical Systems
510(k) numberK992506
Submission
- Device name
- Mini 6800 Digital Mobile C-Arm
- Applicant
- Ge Dec Medical Systems
Salt Lake City, UT, US - Received
- July 27, 1999
- Decision date
- August 19, 1999
- 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 |
More from Ge Oec Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K000221 | Series 7700 Mobile C-Arm, Compact 7700 Mobile C-Arm, Compact 7700 Plus Mobile C-ArmOWB · Abbreviated | 04/11/2000SE |
| K993687 | Uroview 2800OWB · Abbreviated | 12/21/1999SE |
| K974355 | Interventional Mobile Digital Imaging System (Herein Called Imdis)OWB · Traditional | 02/17/1998SE |
| K970063 | Series 7600 Mobile Digital C-ArmOWB · Traditional | 03/11/1997SE |
| K963952 | Series 9600 Mobile Digital Imaging SystemOWB · Traditional | 12/23/1996SE |
| K950781 | Compact 7600JAA · Traditional | 06/05/1995SE |
| K951765 | Series 6600 Digital Mobile C-ArmOXO · Traditional | 05/11/1995SE |
| K940295 | Uroview Model 2600JAA · Traditional | 08/22/1994SE |
| K936136 | Uroview Systems Tomography Option SoftwareJAA · Traditional | 01/25/1994SE |
Questions and answers
When was Mini 6800 Digital Mobile C-Arm cleared by the FDA?
Mini 6800 Digital Mobile C-Arm (K992506) received a 510(k) decision of Substantially Equivalent on August 19, 1999, 23 days after the submission was received.
What is the product code of K992506?
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.