Whale
Catalogue number DigiArc 100AU, listed by Beijing East Whale Imaging Technology Co., Ltd., China, 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
5510(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 | Beijing East Whale Imaging Technology Co., Ltd., China |
|---|---|
| FDA product code | OXO |
| Device type | Image-Intensified Fluoroscopic X-Ray System, Mobile |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| 510(k) | K151280 |
| Record published | 2016-09-04 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 55 °C; Storage environment humidity 10 to 85 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal |
| Sizes | Weight 600 kg; width 922 mm; length 2234 mm; height 2540 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DigiArc 100AU | Weight 600 kg | 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 |
|---|---|
| K163429 | 2017-01-04 |
| K160984 | 2016-07-20 |
| K151280 | 2015-09-30 |
| K141672 | 2014-07-31 |
| K131423 | 2013-11-07 |
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.