XAMINER

System, X-ray, Stationary

IMAGING DYNAMICS COMPANY LTD.

The following data is part of a premarket notification filed by Imaging Dynamics Company Ltd. with the FDA for Xaminer.

Pre-market Notification Details

• Device ID: K061595
• 510k Number: K061595
• Device Name: XAMINER
• Classification: System, X-ray, Stationary
• Applicant: IMAGING DYNAMICS COMPANY LTD. 151,2340 PEGASUS WAY, NE Calgary, Alberta, CA T2e 8m5
• Contact: Shirantha Samarappuli
• Correspondent: Shirantha Samarappuli; IMAGING DYNAMICS COMPANY LTD. 151,2340 PEGASUS WAY, NE Calgary, Alberta, CA T2e 8m5
• Product Code: KPR
• CFR Regulation Number: 892.1680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-06-08
• Decision Date: 2006-08-17
• Summary: summary