The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Xknife-4.
| Device ID | K981055 |
| 510k Number | K981055 |
| Device Name: | XKNIFE-4 |
| Classification | Accelerator, Linear, Medical |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Contact | Lisa Misterka Benati |
| Correspondent | Lisa Misterka Benati RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-23 |
| Decision Date | 1998-09-29 |
| Summary: | summary |