The following data is part of a premarket notification filed by Elekta Oncology Systems, Ltd. with the FDA for Modification To: Viewgt Electronic Portal Imaging Device (epid).
| Device ID | K012289 |
| 510k Number | K012289 |
| Device Name: | MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) |
| Classification | Accelerator, Linear, Medical |
| Applicant | ELEKTA ONCOLOGY SYSTEMS, LTD. 3155 NORTHWOODS PKWY. Norcross, GA 30071 |
| Contact | Peter Stegagno |
| Correspondent | Peter Stegagno ELEKTA ONCOLOGY SYSTEMS, LTD. 3155 NORTHWOODS PKWY. Norcross, GA 30071 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-20 |
| Decision Date | 2001-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060191071055 | K012289 | 000 |