TRON

Interventional Fluoroscopic X-ray System

Xoran Technologies LLC

The following data is part of a premarket notification filed by Xoran Technologies Llc with the FDA for Tron.

Pre-market Notification Details

• Device ID: K221230
• 510k Number: K221230
• Device Name: TRON
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: Xoran Technologies LLC 5210 S. State Rd. Ann Arbor, MI 48108
• Contact: Mark McGarrow
• Correspondent: Mark McGarrow; Xoran Technologies LLC 5210 S. State Rd. Ann Arbor, MI 48108
• Product Code: OWB
• Subsequent Product Code: JAK
• Subsequent Product Code: OXO
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-04-29
• Decision Date: 2022-07-28