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 |