PATRIOT

System, Image Processing, Radiological

INFIMED, INC.

The following data is part of a premarket notification filed by Infimed, Inc. with the FDA for Patriot.

Pre-market Notification Details

• Device ID: K963037
• 510k Number: K963037
• Device Name: PATRIOT
• Classification: System, Image Processing, Radiological
• Applicant: INFIMED, INC. 121 METROPOLITAN DR. Liverpool, NY 13088
• Contact: Morteza Minaee
• Correspondent: Morteza Minaee; INFIMED, INC. 121 METROPOLITAN DR. Liverpool, NY 13088
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-08-05
• Decision Date: 1996-09-27