ZOOM

System, Image Processing, Radiological

Zetta Medical Technologies, LLC.

The following data is part of a premarket notification filed by Zetta Medical Technologies, Llc. with the FDA for Zoom.

Pre-market Notification Details

• Device ID: K172768
• 510k Number: K172768
• Device Name: ZOOM
• 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: 2017-09-13
• Decision Date: 2018-04-24
• Summary: summary