ABARIS
System, X-ray, Tomography, Computed
TRAXTAL TECHNOLOGIES INC.
The following data is part of a premarket notification filed by Traxtal Technologies Inc. with the FDA for Abaris.
Pre-market Notification Details
| Device ID | K053610 |
| 510k Number | K053610 |
| Device Name: | ABARIS |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | TRAXTAL TECHNOLOGIES INC. 49 SPADINA AVENUE, #402C Toronto, Ontario, CA M5v 2j1 |
| Contact | Neil Glossop |
| Correspondent | Neil Glossop TRAXTAL TECHNOLOGIES INC. 49 SPADINA AVENUE, #402C Toronto, Ontario, CA M5v 2j1 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-27 |
| Decision Date | 2006-04-19 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838083592 | K053610 | 000 |
| 00884838081550 | K053610 | 000 |
| 00884838081543 | K053610 | 000 |
| 00884838066991 | K053610 | 000 |
Trademark Results [ABARIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ABARIS 86964155 5510696 Live/Registered |
Profound Nutrition Limited 2016-04-05 |
 ABARIS 73780780 1563875 Dead/Cancelled |
ABARIS 1989-02-10 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.