AVANZA

Couch, Radiation Therapy, Powered

MDS NORDION

The following data is part of a premarket notification filed by Mds Nordion with the FDA for Avanza.

Pre-market Notification Details

• Device ID: K060870
• 510k Number: K060870
• Device Name: AVANZA
• Classification: Couch, Radiation Therapy, Powered
• Applicant: MDS NORDION 447 MARCH RD. Ottawa, Ontario, CA K2k1x8
• Contact: Ross Kachaniwsky
• Correspondent: Ross Kachaniwsky; MDS NORDION 447 MARCH RD. Ottawa, Ontario, CA K2k1x8
• Product Code: JAI
• CFR Regulation Number: 892.5770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-03-30
• Decision Date: 2006-05-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00754014600052	K060870	000
07540146000050	K060870	000