The following data is part of a premarket notification filed by Medicalibration Physics Consultant Services, Inc. with the FDA for Compute-rx Plan Pc3d.
| Device ID | K953508 |
| 510k Number | K953508 |
| Device Name: | COMPUTE-RX PLAN PC3D |
| Classification | Accelerator, Linear, Medical |
| Applicant | MEDICALIBRATION PHYSICS CONSULTANT SERVICES, INC. 558 VAN DYKEN WAY P.O. BOX 6 Ripon, CA 95366 |
| Contact | Ralph Rydman |
| Correspondent | Ralph Rydman MEDICALIBRATION PHYSICS CONSULTANT SERVICES, INC. 558 VAN DYKEN WAY P.O. BOX 6 Ripon, CA 95366 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-26 |
| Decision Date | 1996-02-26 |