# K101503: Dusimetry Check

- Pathway: 510(k) (Traditional)
- Applicant: Math Resolutions, LLC
- Decided: Aug 4, 2010 after 64 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 K010225 (2001). 1 ancestor in all.
8 later devices descend from it; 5 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010225: Dosimetry Check, Math Resolutions, LLC (2001)

## Most influential descendants
- K132605: Dosimetry Check Version 4 Release 1 (2013), 4 descendants of its own
- K112723: Epigray (2012), 1 descendant of its own
- K170345: Softdiso (2017), 0 descendants of its own
- K162577: Dosimetry Check Version 5 Release 1 (2016), 0 descendants of its own
- K152994: Adaptivo (2016), 0 descendants of its own

## Indications for use
The product is to be used by radiation oncologist, dosimetrist, and radiation therapy physicist to check the correctness of the x-ray treatment fields from high energy treatment machines that are planned to be or have been applied to a patient. This product is to be used in addition to the treatment planning system to provide a means for additional and redundant verification that the plan is in fact successfully accomplished. 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 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 clinical information to the radiation oncologist.

Source page: https://510kreport.com/device/K101503
Methodology: https://510kreport.com/methodology