The following data is part of a premarket notification filed by Beijing East Whale Imaging Technology Co., Ltd. with the FDA for G-arm Multiscan System.
| Device ID | K131423 |
| 510k Number | K131423 |
| Device Name: | G-ARM MULTISCAN SYSTEM |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD. NO. 2 WORKSHOP BLDG 2, NO 9 KECHUANG 2 STREET BEIJING ECONOMY TECHNOLOGY Beijing, CN 100023 |
| Contact | Better Li |
| Correspondent | Better Li BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD. NO. 2 WORKSHOP BLDG 2, NO 9 KECHUANG 2 STREET BEIJING ECONOMY TECHNOLOGY Beijing, CN 100023 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-16 |
| Decision Date | 2013-11-07 |
| Summary: | summary |