O-ARM®
O-ARM RFB BI70002000 O2 UE 120V B EN UEN
5manufacturers in China registered for this device type
11catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Guangdong (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 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Medtronic Navigation, Inc., United States |
|---|---|
| FDA product code | OWB |
| Device type | Interventional Fluoroscopic X-Ray System |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-08-01 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| BI90000048 | 10 | In distribution | |
| BI70002000 | In distribution | ||
| BI40000015 | In distribution | ||
| BI70002000 | In distribution | ||
| BI70002000 | In distribution | ||
| BI70002000 | In distribution | ||
| BI70002000 | In distribution | ||
| BI70002000 | In distribution | ||
| BI70002000 | In distribution | ||
| BI71000547 | In distribution | ||
| BI70002000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TrackX | Trackx Technology Inc. | 86 |
| Trinias | Shimadzu Corp. | 54 |
| Allura Xper FD | Philips Medical Systems Nederland B.V. | 21 |
| Azurion | Philips Medical Systems Nederland B.V. | 19 |
| LessRay | Nuvasive, Inc. | 16 |
| Intelli-C Accessory | Nrt – Nordisk Røntgen Teknik A/S | 13 |
| Pulse | Nuvasive, Inc. | 12 |
| Genoray | Genoray Co., Ltd. | 10 |
| Fujifilm Healthcare Americas Corporation | A.T.S. Applicazione Tecnologie Speciali SRL | 7 |
| Fujifilm Medical Systems U.S.A. Inc. | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
| Stephanix | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
| Amrad Medical | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
Showing 12 of 122. All products under Interventional Fluoroscopic X-Ray System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240465 | 2024-06-21 |
Recalls Naming This Product
4 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 | 2024-04-26 | Class II | Device Design | Potential for an electrical component of the O-arm” O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery with | 20 units | |
| 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.