OrthoScan HD Mini C-Arm
Catalogue number 1000-0004, listed by Ziehm-Orthoscan, Inc., United States, under Image-Intensified Fluoroscopic X-Ray System, Mobile. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
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 | Ziehm-Orthoscan, 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 |
| 510(k) | K051754 |
| Record published | 2017-03-07 |
| Record revised | 2023-08-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 32 to 131 °F; Handling environment temperature 0 to 55 °C; Handling environment humidity 10 to 100 % RH; Handling environment atmospheric pressure 500 to 1060 millibar |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1000-0004 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| O-ARM® | Medtronic Navigation, Inc. | 16 |
| 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 |
Showing 12 of 40. All products under Image-Intensified Fluoroscopic X-Ray System, Mobile
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252579 | 2026-01-14 |
| K250587 | 2025-07-02 |
| K243452 | 2025-01-14 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Orthoscan, Inc. | 510(k) number | 2017-08-31 | Class II | Software design | OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a | 2012 total | 2021-04-21 |
| Orthoscan, Inc. | 510(k) number | 2017-08-31 | Class II | Software design | OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a | 2012 total | 2021-04-21 |
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.