The following data is part of a premarket notification filed by Elekta Limited with the FDA for Iviewdose R1.0.
| Device ID | K153011 |
| 510k Number | K153011 |
| Device Name: | IViewDose R1.0 |
| Classification | Accelerator, Linear, Medical |
| Applicant | Elekta Limited Linac House Fleming Way Crawley, GB Rh10 9rr |
| Contact | Maurice Paine |
| Correspondent | Maurice Paine Elekta Limited Linac House Fleming Way Crawley, GB Rh10 9rr |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-14 |
| Decision Date | 2015-12-11 |
| Summary: | summary |