Digiscope RX-2 (9 Option)
FDA 510(k) K965013 · Medirex, Inc.
510(k) numberK965013
Submission
- Device name
- Digiscope RX-2 (9 Option)
- Applicant
- Medirex, Inc.
Wellesley Hills, MA, US - Received
- December 16, 1996
- Decision date
- January 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K253296 | Digital C-ARM with 3DOXO · Traditional | Allengers Medical Systems Limited | 06/05/2026SE |
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| 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 |
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Questions and answers
When was Digiscope RX-2 (9 Option) cleared by the FDA?
Digiscope RX-2 (9 Option) (K965013) received a 510(k) decision of Substantially Equivalent on January 17, 1997, 32 days after the submission was received.
What is the product code of K965013?
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.