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 |