# K142431: WaterProof PROFILER

- Pathway: 510(k) (Traditional)
- Applicant: Sun Nuclear Corporation
- Decided: Dec 5, 2014 after 98 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 K063021 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063021: Profiler 2, Sun Nuclear Corp. (2006) Summary page 4.
- K101992: 3D Scanner, Model 1230, Sun Nuclear Corp. (2010) Summary page 5.

## Indications for use
The Model 1203 WaterProof PROFILER is intended for radiotherapy dosimetry measurements for commissioning a treatment planning system (TPS) computer. It is also intended for periodic beam quality assurance (QA) tests as defined by the medical physicist responsible for the QA program.

Source page: https://510kreport.com/device/K142431
Methodology: https://510kreport.com/methodology