The following data is part of a premarket notification filed by Elekta Ltd. with the FDA for Desktop Pro.
| Device ID | K080585 |
| 510k Number | K080585 |
| Device Name: | DESKTOP PRO |
| Classification | Accelerator, Linear, Medical |
| Applicant | ELEKTA LTD. LINAC HOUSE FLEMING WAY, CRAWLEY West Sussex, GB Rh10 9rr |
| Contact | Patrick T.m. Hull |
| Correspondent | Patrick T.m. Hull ELEKTA LTD. LINAC HOUSE FLEMING WAY, CRAWLEY West Sussex, 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 | 2008-03-03 |
| Decision Date | 2008-06-11 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DESKTOP PRO 85948781 4487646 Live/Registered |
Denton Vacuum, L.L.C. 2013-06-03 |