The following data is part of a premarket notification filed by Oncology Data Systems, Inc. with the FDA for Mucheck, Version 9.0.
| Device ID | K102583 |
| 510k Number | K102583 |
| Device Name: | MUCHECK, VERSION 9.0 |
| Classification | Accelerator, Linear, Medical |
| Applicant | ONCOLOGY DATA SYSTEMS, INC. 1601 SW 89TH STREET BUILDING E-100 Oklahoma City, OK 73159 |
| Contact | Vincent Ruminer |
| Correspondent | Vincent Ruminer ONCOLOGY DATA SYSTEMS, INC. 1601 SW 89TH STREET BUILDING E-100 Oklahoma City, OK 73159 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-08 |
| Decision Date | 2010-11-02 |
| Summary: | summary |