The following data is part of a premarket notification filed by Oncology Data Systems, Inc. with the FDA for Mucheck V7.0.
| Device ID | K061152 |
| 510k Number | K061152 |
| Device Name: | MUCHECK V7.0 |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | ONCOLOGY DATA SYSTEMS, INC. 1601 SW 89TH STREET BUILDING E-100 Oklahoma City, OK 73159 |
| Contact | Greg Miller |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LHN |
| Subsequent Product Code | JAQ |
| Subsequent Product Code | KXK |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-04-26 |
| Decision Date | 2006-05-10 |
| Summary: | summary |