The following data is part of a premarket notification filed by Prowess, Inc. with the FDA for Panther Realart, Model 4.7.
| Device ID | K083502 |
| 510k Number | K083502 |
| Device Name: | PANTHER REALART, MODEL 4.7 |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | PROWESS, INC. 5063 COMMERCIAL CIRCLE SUITE A&B Concord, CA 94520 |
| Contact | Rachel Scarano |
| Correspondent | Rachel Scarano PROWESS, INC. 5063 COMMERCIAL CIRCLE SUITE A&B Concord, CA 94520 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-25 |
| Decision Date | 2009-05-05 |
| Summary: | summary |