The following data is part of a premarket notification filed by Zetta Medical Technologies, Llc. with the FDA for Zia.
| Device ID | K160852 |
| 510k Number | K160852 |
| Device Name: | Zia |
| Classification | System, Image Processing, Radiological |
| Applicant | Zetta Medical Technologies, LLC. 1313 Ensell Road Lake Zurich, IL 60047 |
| Contact | Main M. Ghazal |
| Correspondent | Main M. Ghazal Zetta Medical Technologies, LLC. 1313 Ensell Road Lake Zurich, IL 60047 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-28 |
| Decision Date | 2016-12-15 |
| Summary: | summary |