The following data is part of a premarket notification filed by C-rad Positioning Ab with the FDA for Positioner.
| Device ID | K063839 |
| 510k Number | K063839 |
| Device Name: | POSITIONER |
| Classification | Accelerator, Linear, Medical |
| Applicant | C-RAD POSITIONING AB KUNGSANGSVAGEN 29 Uppsala, SE 75323 |
| Contact | Bengt Eric Rosth |
| Correspondent | Bengt Eric Rosth C-RAD POSITIONING AB KUNGSANGSVAGEN 29 Uppsala, SE 75323 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-26 |
| Decision Date | 2007-02-08 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() POSITIONER 85571422 not registered Dead/Abandoned |
Orthopedic Positioning Solutions, LLC 2012-03-16 |
![]() POSITIONER 75093866 not registered Dead/Abandoned |
Omtron, Inc. 1996-04-25 |
![]() POSITIONER 74223137 1812832 Dead/Cancelled |
A-Dec, Inc. 1991-11-19 |