The following data is part of a premarket notification filed by Imaging Dynamics Company Ltd. with the FDA for Orthoxp.
Device ID | K062634 |
510k Number | K062634 |
Device Name: | ORTHOXP |
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 | 2006-09-06 |
Decision Date | 2006-10-06 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ORTHOXP 78698458 3458000 Dead/Cancelled |
Imaging Dynamics Company Ltd. 2005-08-23 |