The following data is part of a premarket notification filed by Radionics Software Applications, Inc. with the FDA for Xplan-1.
| Device ID | K972905 |
| 510k Number | K972905 |
| Device Name: | XPLAN-1 |
| Classification | Accelerator, Linear, Medical |
| Applicant | RADIONICS SOFTWARE APPLICATIONS, INC. 22 TERRY AVE. Burlington, MA 01803 -0658 |
| Contact | Linda Talbert |
| Correspondent | Linda Talbert RADIONICS SOFTWARE APPLICATIONS, INC. 22 TERRY AVE. Burlington, MA 01803 -0658 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-06 |
| Decision Date | 1997-10-28 |
| Summary: | summary |