# K153011: iViewDose R1.0

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Limited
- Decided: Dec 11, 2015 after 58 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: 3 generations back to K010225 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112723: Epigray, Dosisoft SA (2012) Summary page 4.
- K132605: Dosimetry Check Version 4 Release 1, Math Resolutions, LLC (2013) Summary page 4.
- K101503: Dusimetry Check, Math Resolutions, LLC (2010) Summary page 4.

## Indications for use
iViewDose is a standalone software tool, available as an optional accessory of the linear accelerator. It is intended to assist in reducing the clinical risk in the delivery of radiotherapy treatments and does not alter the treatment delivery, or impact the clinical workflow. The software is to be used for the purposes of detecting gross errors during the delivery of radiation therapy. The software acquires data using the iViewGT Electronic Portal Imaging Device at the time of treatment (or prior to treatment) and subsequently processes it. The processed data is compared with data calculated by the treatment planning system. The comparison is derived from the application of dose conversion and reconstruction algorithms to the EPID data, which is back-projected to a plane normal to a beam (2D) or multiple planes (3D) inside the patient (in vivo) or phantom (pre-treatment). iViewDose is not a treatment planning system, and provides an independent means of checking the dose delivered to the patient. iViewDose therefore provides an added level of treatment assurance, thus giving clinicians greater confidence especially when complex treatment techniques are employed. iViewDose is intended to support decision making in relation to the delivery of radiation to defined target volumes performed with Elekta linear accelerators only.

Source page: https://510kreport.com/device/K153011
Methodology: https://510kreport.com/methodology