The following data is part of a premarket notification filed by Integra Radionics, Inc. with the FDA for Radionics Xknife Hdrt System.
| Device ID | K083414 |
| 510k Number | K083414 |
| Device Name: | RADIONICS XKNIFE HDRT SYSTEM |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington, MA 01803 |
| Contact | Kevin O'connell |
| Correspondent | Kevin O'connell INTEGRA RADIONICS, INC. 22 TERRY AVENUE 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 | 2008-11-18 |
| Decision Date | 2009-03-02 |
| Summary: | summary |