The following data is part of a premarket notification filed by Radionics Software Applications, Inc. with the FDA for Xknife-3.
| Device ID | K953482 |
| 510k Number | K953482 |
| Device Name: | XKNIFE-3 |
| Classification | Accelerator, Linear, Medical |
| Applicant | RADIONICS SOFTWARE APPLICATIONS, INC. 22 TERRY AVE. Burlington, MA 01803 -2591 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert RADIONICS SOFTWARE APPLICATIONS, INC. 22 TERRY AVE. Burlington, MA 01803 -2591 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-24 |
| Decision Date | 1995-10-25 |