# K131466: MAPCHECK2, Arccheck

- Pathway: 510(k) (Traditional)
- Applicant: Sun Nuclear Corporation
- Decided: Aug 20, 2013 after 91 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 K935928 (1994). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935928: Rit 113 Film Analysis System, Radiological Imaging Technology, Inc. (1994) Summary page 1.

## Most influential descendants
- K142617: ArcCHECK (2015), 1 descendant of its own
- K160405: Octavius I, Octavius II, Octavius Iii, Octavius 4D (2017), 0 descendants of its own
- K160057: ArcCHECK-MR (2016), 0 descendants of its own

## Indications for use
Model 1177 MapCHECK 2 is a two-dimensional (2D) radiotherapy beam dosimetry QA system intended for the measurement of radiation dose distributions for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS). ArcCHECK, Model 1220 is a three-dimensional (3D) radiotherapy beam dosimetry QA system intended for the measurement of radiation dose distributions for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS).

Source page: https://510kreport.com/device/K131466
Methodology: https://510kreport.com/methodology