MINICAT

System, X-ray, Tomography, Computed

XORAN TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Xoran Technologies, Inc. with the FDA for Minicat.

Pre-market Notification Details

• Device ID: K113421
• 510k Number: K113421
• Device Name: MINICAT
• Classification: System, X-ray, Tomography, Computed
• Applicant: XORAN TECHNOLOGIES, INC. 5210 South State Road Ann Arbor, MI 48108
• Contact: Martha Rumford
• Correspondent: Martha Rumford; XORAN TECHNOLOGIES, INC. 5210 South State Road Ann Arbor, MI 48108
• Product Code: JAK
• CFR Regulation Number: 892.1750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-11-18
• Decision Date: 2012-07-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860290000353	K113421	000
00860290000315	K113421	000
00860290000308	K113421	000
00860008443731	K113421	000