The following data is part of a premarket notification filed by Accelerator Systems Intl., Inc. with the FDA for Medical Linear Accelerator.
| Device ID | K935615 |
| 510k Number | K935615 |
| Device Name: | MEDICAL LINEAR ACCELERATOR |
| Classification | Accelerator, Linear, Medical |
| Applicant | ACCELERATOR SYSTEMS INTL., INC. 552 GIBRALTAR AVE. Milpitas, CA 95035 |
| Contact | Dean Antonopolos |
| Correspondent | Dean Antonopolos ACCELERATOR SYSTEMS INTL., INC. 552 GIBRALTAR AVE. Milpitas, CA 95035 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-22 |
| Decision Date | 1995-06-09 |