The following data is part of a premarket notification filed by Mds Nordion Inc. with the FDA for Theratron Equinox, Models 80 Cm And 100 Cm.
| Device ID | K053485 |
| 510k Number | K053485 |
| Device Name: | THERATRON EQUINOX, MODELS 80 CM AND 100 CM |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | MDS NORDION INC. 447 MARCH ROAD Ottawa, Ontario, CA K2k 1x8 |
| Contact | Ross Kachaniwsky |
| Correspondent | Ross Kachaniwsky MDS NORDION INC. 447 MARCH ROAD Ottawa, Ontario, CA K2k 1x8 |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-15 |
| Decision Date | 2006-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00754014600038 | K053485 | 000 |
| 07540146000036 | K053485 | 000 |