The following data is part of a premarket notification filed by Prodigm Group, Inc. with the FDA for Wimrt Module For Artp Planning System.
| Device ID | K041971 |
| 510k Number | K041971 |
| Device Name: | WIMRT MODULE FOR ARTP PLANNING SYSTEM |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | PRODIGM GROUP, INC. 19078 CHAPARRAL DRIVE Penn Valley, CA 95946 |
| Contact | Lee Potts |
| Correspondent | Lee Potts PRODIGM GROUP, INC. 19078 CHAPARRAL DRIVE Penn Valley, CA 95946 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-22 |
| Decision Date | 2005-05-20 |
| Summary: | summary |