The following data is part of a premarket notification filed by Advantage Medical Systems, Inc. with the FDA for New Rad-8 Treatment Planning Computer System.
| Device ID | K894568 |
| 510k Number | K894568 |
| Device Name: | NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | ADVANTAGE MEDICAL SYSTEMS, INC. 121 NORTH EAGLE ST. Geneva, OH 44041 |
| Contact | Sherry Stein |
| Correspondent | Sherry Stein ADVANTAGE MEDICAL SYSTEMS, INC. 121 NORTH EAGLE ST. Geneva, OH 44041 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-21 |
| Decision Date | 1990-01-09 |