The following data is part of a premarket notification filed by Zed Technologies with the FDA for Zed Link.
| Device ID | K180549 |
| 510k Number | K180549 |
| Device Name: | ZED Link |
| Classification | System, Image Processing, Radiological |
| Applicant | Zed Technologies 12 Yarra Street, Office 105 South Yarra, AU Vic 3141 |
| Contact | Ronald Li |
| Correspondent | Carl Alletto OTech Inc. 8317 Belew Drive Mckinney, TX 75071 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-01 |
| Decision Date | 2018-04-12 |
| Summary: | summary |