MultiScan G-Arm System
Image-intensified Fluoroscopic X-ray System, Mobile
BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD
The following data is part of a premarket notification filed by Beijing East Whale Imaging Technology Co., Ltd with the FDA for Multiscan G-arm System.
Pre-market Notification Details
| Device ID | K160984 |
| 510k Number | K160984 |
| Device Name: | MultiScan G-Arm System |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD B2-2 NEW CITY INDUSTRIAL PARK, NO.9 KECHUANG 2ND ST. YIZHUANG Beijing, CN 100023 |
| Contact | Sharon Fan |
| Correspondent | Sharon Fan BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD B2-2 NEW CITY INDUSTRIAL PARK, NO.9 KECHUANG 2ND ST. YIZHUANG 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 | 2016-04-07 |
| Decision Date | 2016-07-20 |
| Summary: | summary |
Trademark Results [MultiScan G-Arm System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MULTISCAN G-ARM SYSTEM 85555738 not registered Dead/Abandoned |
BEIJING EAST WHALE IMAGE TECHNOLOGY CO., LTD. 2012-02-29 |
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