The following data is part of a premarket notification filed by Elekta Ltd. with the FDA for Clarity Obp System.
| Device ID | K111332 |
| 510k Number | K111332 |
| Device Name: | CLARITY OBP SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | ELEKTA LTD. 2050 BLEURY, SUITE 200 Montreal, CA H3a 2j5 |
| Contact | George Papagiannis |
| Correspondent | George Papagiannis ELEKTA LTD. 2050 BLEURY, SUITE 200 Montreal, CA H3a 2j5 |
| Product Code | IYE |
| Subsequent Product Code | IWB |
| Subsequent Product Code | KPQ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-11 |
| Decision Date | 2012-01-30 |
| Summary: | summary |