# K141800: Perfraction

- Pathway: 510(k) (Traditional)
- Applicant: Sun Nuclear Corporation
- Decided: Sep 26, 2014 after 85 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: 4 generations back to K914698 (1992). 12 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072374: Compass, Scanditronix Wellhofer GmbH (2007) Summary page 4.

## Most influential descendants
- K170307: SunCHECK (2017), 1 descendant of its own
- K252258: Veriqa RT Epid 3D (2026), 0 descendants of its own
- K213370: Veriqa (2022), 0 descendants of its own
- K172534: LINACwatch, LinacView (2017), 0 descendants of its own
- K152994: Adaptivo (2016), 0 descendants of its own

## Indications for use
PerFRACTION is intended to allow for the detection of errors that can occur in the delivery of a patient’s radiation therapy treatment. PerFRACTION allows for the comparison of the cumulative exit image(s) for one treatment fraction to the cumulative exit image(s) for another treatment fraction, thus providing a consistency check on the delivery of the treatment fraction.

Source page: https://510kreport.com/device/K141800
Methodology: https://510kreport.com/methodology