The following data is part of a premarket notification filed by Computerized Medical Systems, Inc. with the FDA for Computerized Radiation Treatment Planning Sys.
| Device ID | K853964 |
| 510k Number | K853964 |
| Device Name: | COMPUTERIZED RADIATION TREATMENT PLANNING SYS |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | COMPUTERIZED MEDICAL SYSTEMS, INC. 2294 WELDON PKWY. St. Louis, MO 63146 |
| Contact | Melvin Mccollum |
| Correspondent | Melvin Mccollum COMPUTERIZED MEDICAL SYSTEMS, INC. 2294 WELDON PKWY. St. Louis, MO 63146 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-16 |
| Decision Date | 1985-12-05 |