The following data is part of a premarket notification filed by Radionics, A Division Of Tyco Healthcare Group Lp with the FDA for Radionics Xknife Rt 3 With Non Stereotactic Module.
| Device ID | K041997 |
| 510k Number | K041997 |
| Device Name: | RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP 22 TERRY AVE. Burlington, MA 01803 |
| Contact | Kevin J O'connell |
| Correspondent | Kevin J O'connell RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP 22 TERRY AVE. Burlington, MA 01803 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-26 |
| Decision Date | 2004-08-27 |
| Summary: | summary |