ZedView
System, Image Processing, Radiological
Lexi Co., Ltd.
The following data is part of a premarket notification filed by Lexi Co., Ltd. with the FDA for Zedview.
Pre-market Notification Details
| Device ID | K200704 |
| 510k Number | K200704 |
| Device Name: | ZedView |
| Classification | System, Image Processing, Radiological |
| Applicant | Lexi Co., Ltd. 2-11-1 Sugamo, Toshima-Ku Tokyo, JP 170-0002 |
| Contact | Takao Kusunoki |
| Correspondent | Takao Kusunoki Lexi Co., Ltd. 2-11-1 Sugamo, Toshima-Ku Tokyo, JP 170-0002 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-18 |
| Decision Date | 2021-05-27 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14573443600029 | K200704 | 000 |
Trademark Results [ZedView]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZEDVIEW 87736895 not registered Live/Pending |
LEXI Co., Ltd. 2017-12-28 |
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