EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM

System, Image Processing, Radiological

MEDICAL INSIGHT A/S

The following data is part of a premarket notification filed by Medical Insight A/s with the FDA for Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image And Data Management System.

Pre-market Notification Details

• Device ID: K051809
• 510k Number: K051809
• Device Name: EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM
• Classification: System, Image Processing, Radiological
• Applicant: MEDICAL INSIGHT A/S 16303 PANORAMIC WAY San Leandro, CA 94578
• Contact: Gary J Allsebrook
• Correspondent: Gary J Allsebrook; MEDICAL INSIGHT A/S 16303 PANORAMIC WAY San Leandro, CA 94578
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-07-05
• Decision Date: 2005-08-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00628105001762	K051809	000
00628105001755	K051809	000
00628105001748	K051809	000
00628105001731	K051809	000
62810500000024	K051809	000