The following data is part of a premarket notification filed by Computerized Medical Systems, Inc. with the FDA for Xio Radiation Treatment Planning System.
| Device ID | K032762 |
| 510k Number | K032762 |
| Device Name: | XIO RADIATION TREATMENT PLANNING SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | COMPUTERIZED MEDICAL SYSTEMS, INC. 1145 CORPORATE LAKE DR. St. Louis, MO 63132 -1716 |
| Contact | Kathryn Stinson |
| Correspondent | Kathryn Stinson COMPUTERIZED MEDICAL SYSTEMS, INC. 1145 CORPORATE LAKE DR. St. Louis, MO 63132 -1716 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-05 |
| Decision Date | 2003-12-02 |
| Summary: | summary |