# K012289: Modification to: Viewgt Electronic Portal Imaging Device (Epid)

- Pathway: 510(k) (Special)
- Applicant: Elekta Oncology Systems, Ltd.
- Decided: Aug 14, 2001 after 25 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981790 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981790: Iview Electronic Portal Imaging Device (Epid) Model Number Ivew, Elekta Oncology Systems, Ltd. (1998) Summary page 2.

## Most influential descendants
- K042733: Standard Imaging Pipspro QA Software System (2004), 0 descendants of its own

## Indications for use
The EOS iViewGT™ Electronic Portal Imaging Device (EPID), as with the predicate iView, is intended to be used with radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

Source page: https://510kreport.com/device/K012289
Methodology: https://510kreport.com/methodology