The following data is part of a premarket notification filed by Elekta Oncology Systems, Ltd. with the FDA for Iview Electronic Portal Imaging Device (epid) Model Number Ivew.
| Device ID | K981790 |
| 510k Number | K981790 |
| Device Name: | IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW |
| Classification | Accelerator, Linear, Medical |
| Applicant | ELEKTA ONCOLOGY SYSTEMS, LTD. 8 EXECUTIVE PARK WEST SUITE 809 Atlanta, GA 30329 |
| Contact | Paul L Sumner |
| Correspondent | Paul L Sumner ELEKTA ONCOLOGY SYSTEMS, LTD. 8 EXECUTIVE PARK WEST SUITE 809 Atlanta, GA 30329 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-20 |
| Decision Date | 1998-08-07 |
| Summary: | summary |