# K160057: ArcCHECK-MR

- Pathway: 510(k) (Traditional)
- Applicant: Sun Nuclear Corporation
- Decided: May 13, 2016 after 122 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 K935928 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142617: ArcCHECK, Sun Nuclear Corporation (2015) Summary page 4.
- K131466: MAPCHECK2, Arccheck, Sun Nuclear Corporation (2013) Summary page 4.

## Indications for use
Model 1220-MR ArcCHECK-MR is a three-dimensional (3D) ionizing radiation measurement device intended for radiotherapy quality assurance.

Source page: https://510kreport.com/device/K160057
Methodology: https://510kreport.com/methodology