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 |