ORTHOVISION
System, Image Processing, Radiological
EWOO SOFT CO., LTD
The following data is part of a premarket notification filed by Ewoo Soft Co., Ltd with the FDA for Orthovision.
Pre-market Notification Details
| Device ID | K131570 |
| 510k Number | K131570 |
| Device Name: | ORTHOVISION |
| Classification | System, Image Processing, Radiological |
| Applicant | EWOO SOFT CO., LTD 12946 KIMBERLEY LN Houston, TX 77079 |
| Contact | Dave Kim |
| Correspondent | Dave Kim EWOO SOFT CO., LTD 12946 KIMBERLEY LN Houston, TX 77079 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-30 |
| Decision Date | 2013-08-15 |
| Summary: | summary |
Trademark Results [ORTHOVISION]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHOVISION 87221015 not registered Live/Pending |
VATECH CO., LTD. 2016-10-31 |
 ORTHOVISION 86552793 5151743 Live/Registered |
Crimson U.S. Assets LLC 2015-03-04 |
 ORTHOVISION 74185618 1698938 Live/Registered |
American Sterilizer Company 1991-07-16 |
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