The following data is part of a premarket notification filed by Integra Radionics, Inc. with the FDA for Xknife 5.
| Device ID | K100417 |
| 510k Number | K100417 |
| Device Name: | XKNIFE 5 |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington, MA 01803 |
| Contact | Kevin J O'connell |
| Correspondent | Kevin J 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 | 2010-02-16 |
| Decision Date | 2010-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M433LTP1 | K100417 | 000 |
| M433XKNIFETK1 | K100417 | 000 |
| M433XK503UPK1 | K100417 | 000 |
| M433XK51 | K100417 | 000 |
| M433RTLXCOMP1 | K100417 | 000 |