O-ARM®
O-ARM RFB BI70002000 O2 UE 120V B EN UEN
3manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Beijing (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
Record
| Listed by | Medtronic Navigation, Inc., United States |
|---|---|
| FDA product code | OXO |
| Device type | Image-Intensified Fluoroscopic X-Ray System, Mobile |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K050996 |
| Record published | 2018-06-25 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| BI70002000 | In distribution | ||
| BI70002000 | In distribution | ||
| BI70002000 | In distribution | ||
| 9733292R | In distribution | ||
| BI70002000 | In distribution | ||
| BI70002000 | In distribution | ||
| 9732721 | In distribution | ||
| 9732721 | 10 | In distribution | |
| 9732721 | 10 | In distribution | |
| BI70002000 | In distribution | ||
| BI70000028120 | In distribution | ||
| BI70000028120 | In distribution | ||
| BI70002000 | In distribution | ||
| BI70000028120 | In distribution | ||
| BI70002000 | In distribution | ||
| BI70000028120R | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cios Select | Siemens Shanghai, Medical Equipment Ltd. | 3 |
| Smart-C | Turner Imaging Systems, Inc. | 3 |
| Zenition | Philips Medical Systems Nederland B.V. | 2 |
| Broach Set SPX1 | Ecential Robotics | 2 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | Ecotron Co., Ltd. | 2 |
| Flourocsan InSight | Hologic, Inc. | 2 |
| Genoray | Genoray Co., Ltd. | 2 |
| 3D Imaging Set SPX1 | Ecential Robotics | 2 |
| Discovery | GE Medical Systems, LLC | 2 |
| OEC | Ge Hualun Medical Systems Co., Ltd. | 2 |
| Cios Alpha | Siemens Healthcare Limited | 1 |
| System, X-RAY, Fluoroscopic, Image-Intensified | Gemss Medical Systems Co., Ltd. | 1 |
Showing 12 of 40. All products under Image-Intensified Fluoroscopic X-Ray System, Mobile
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Navigation, Inc. (Boxborough) | UDI-DI | 2023-07-25 | Class II | Under Investigation by firm | Ground cable installed incorrectly. | 28 units | |
| Medtronic Navigation, Inc. (Boxborough) | UDI-DI | 2019-11-15 | Class II | Device Design | Due to a manufacturing issue affecting particular O-arm” O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may loosen over an extended number of uses at a higher frequency in these systems. If the belt lo | 90 | 2023-09-19 |
| Medtronic Navigation, Inc. | UDI-DI | 2019-08-09 | Class I | Software design | Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm’s Steriotactic System and auto-registration feature with a specific imaging syste | 61 customers purchased the specified combination of equipmen | 2024-04-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.