The following data is part of a premarket notification filed by Lexi Co., Ltd. with the FDA for Zedview.
| Device ID | K133022 |
| 510k Number | K133022 |
| Device Name: | ZEDVIEW |
| Classification | System, Image Processing, Radiological |
| Applicant | LEXI CO., LTD. 5905 FAWN LANE Cleveland, OH 44141 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll LEXI CO., LTD. 5905 FAWN LANE Cleveland, OH 44141 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-26 |
| Decision Date | 2014-03-06 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ZEDVIEW 87736895 not registered Live/Pending |
LEXI Co., Ltd. 2017-12-28 |