The following data is part of a premarket notification filed by Viewray Incorporated with the FDA for Viewray Treatment Planning And Delivery System.
| Device ID | K102915 |
| 510k Number | K102915 |
| Device Name: | VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | VIEWRAY INCORPORATED 2 THERMOFISHER WAY Oakwood, OH 44146 |
| Contact | Janice Brownlee |
| Correspondent | Janice Brownlee VIEWRAY INCORPORATED 2 THERMOFISHER WAY Oakwood, OH 44146 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-01 |
| Decision Date | 2011-01-12 |
| Summary: | summary |