The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Xplan-2 With Head And Neck Localizer, Model Hnl.
| Device ID | K991237 |
| 510k Number | K991237 |
| Device Name: | XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Contact | Nancy Macdonald |
| Correspondent | Nancy Macdonald RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-12 |
| Decision Date | 1999-08-30 |
| Summary: | summary |