The following data is part of a premarket notification filed by Radionics Software Applications, Inc. with the FDA for Linac-based Sterotactic Radiosurgery.
Device ID | K923522 |
510k Number | K923522 |
Device Name: | LINAC-BASED STEROTACTIC RADIOSURGERY |
Classification | Accelerator, Linear, Medical |
Applicant | RADIONICS SOFTWARE APPLICATIONS, INC. 2 BROOKLINE PLACE SUITE 204 Brookline, MA 02146 |
Contact | Linda Jalbert |
Correspondent | Linda Jalbert RADIONICS SOFTWARE APPLICATIONS, INC. 2 BROOKLINE PLACE SUITE 204 Brookline, MA 02146 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-16 |
Decision Date | 1993-08-18 |