The following data is part of a premarket notification filed by Ssgi Prowess Systems with the FDA for Modification To Prowess Pro-sim.
| Device ID | K984196 |
| 510k Number | K984196 |
| Device Name: | MODIFICATION TO PROWESS PRO-SIM |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | SSGI PROWESS SYSTEMS 1370 RIDGEWOOD DR., #20 Chico, CA 95973 -7803 |
| Contact | Robert J Morton |
| Correspondent | Robert J Morton SSGI PROWESS SYSTEMS 1370 RIDGEWOOD DR., #20 Chico, CA 95973 -7803 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-23 |
| Decision Date | 1998-12-11 |
| Summary: | summary |