# K981790: Iview Electronic Portal Imaging Device (Epid) Model Number Ivew

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Oncology Systems, Ltd.
- Decided: Aug 7, 1998 after 79 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) SRI 100 electronic portal imaging device: named in the summary without a submission number

## Most influential descendants
- K012289: Modification to: Viewgt Electronic Portal Imaging Device (Epid) (2001), 1 descendant of its own
- K042733: Standard Imaging Pipspro QA Software System (2004), 0 descendants of its own

## Recalls of this device
- Jul 31, 2009 · Not classified · Z-1436-2010: Image problems that have an effect on patient position corrections and on the accuracy of the radiation treatment.

## Indications for use
The EOS iView EPID, as with the predicate SRI 100, 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/K981790
Methodology: https://510kreport.com/methodology