# K132605: Dosimetry Check Version 4 Release 1

- Pathway: 510(k) (Traditional)
- Applicant: Math Resolutions, LLC
- Decided: Nov 14, 2013 after 86 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: 2 generations back to K010225 (2001). 2 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101503: Dusimetry Check, Math Resolutions, LLC (2010) Summary page 2.

## Most influential descendants
- K162577: Dosimetry Check Version 5 Release 1 (2016), 0 descendants of its own
- K152994: Adaptivo (2016), 0 descendants of its own
- K153011: iViewDose R1.0 (2015), 0 descendants of its own
- K143269: Delivery Analysis (2015), 0 descendants of its own

## Indications for use
Dosimetry Check is a standalone software product intended to be used by an experienced radiological physicist for quality control purposes only. Dosimetry Check is intended to check the correctness of x-ray treatment plans delivered from high energy charged-particle radiation therapy treatment machines by using a measurement of the applied radiation fields that are planned to or have been applied to a patient, and computing the dose to the patient from the measured radiation fields. This product is to be used as a quality control check for the treatment planning system and delivery system. Dosimetry Check quality control software uses the radiation fields that are measured with media such as x-ray film, electronic portal imaging devices (EPID). diode or ion chamber arrays, or in the case of TomoTherapy. a fan line detector array, and provides a theoretical calculation. Dosimetry Check computes the dose and dose distribution using the patient specific computed tomography (CT) or other image set or alternately a phantom that is likewise scanned, to calculate the reconstructed dose that is then compared to the plan dose. The results reported can include the computed percent difference at specific point as compared to the patient specific radiation treatment plan. This product is not a treatment planning system and is not to be used as one. This product only checks the applied dose based on the measurement of each x-ray field applied to the patient and provided in an exported file, and a theoretical calculation. This product does not provide any quality assurance that the fields are in fact correctly applied to and correctly aligned with the patient anatomy as planned. In addition, the product may be used to display the above dose on other fused image sets which could provide additional supportive quality information to the user regarding the correctness of treatment.

Source page: https://510kreport.com/device/K132605
Methodology: https://510kreport.com/methodology