# K973540: Elekta Oncology Systems Icom/Quickmode Software Options

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Oncology Systems, Inc.
- Decided: Dec 17, 1997 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Philips SLi Series Linear Accelerators: named in the summary without a submission number

## Indications for use
The EOS iCom/QuickMode Software Options, as with the predicate SLi Series system, is intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

Source page: https://510kreport.com/device/K973540
Methodology: https://510kreport.com/methodology