The following data is part of a premarket notification filed by Computerized Medical Systems, Inc. with the FDA for Focus Pilot Contouring Workstation.
| Device ID | K981535 |
| 510k Number | K981535 |
| Device Name: | FOCUS PILOT CONTOURING WORKSTATION |
| Classification | Accelerator, Linear, Medical |
| Applicant | COMPUTERIZED MEDICAL SYSTEMS, INC. 1195 CORPORATE LAKE DR. St. Louis, MO 63132 -1716 |
| Contact | Michael A Parsons |
| Correspondent | Michael A Parsons COMPUTERIZED MEDICAL SYSTEMS, INC. 1195 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 | 1998-04-29 |
| Decision Date | 1999-04-02 |
| Summary: | summary |