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 |