# K142142: Quality Reports

- Pathway: 510(k) (Traditional)
- Applicant: Sun Nuclear Corporation
- Decided: Dec 5, 2014 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: 11 generations back to K954874 (1996). 47 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123230: Mosaiq Oncology Information System, Impac Medical Systems, Inc. (2012) Summary page 4.
- K120067: Mosaiq Oncology Information System, Impac Medical Systems, Inc. (2012) Summary page 5.

## Most influential descendants
- K162468: ClearCheck (2016), 4 descendants of its own
- K220583: ClearCheck Model RADCC V2 (2022), 3 descendants of its own
- K231185: MapRT (2023), 1 descendant of its own
- K253962: ClearCheck (RADCC V2.7) (2026), 0 descendants of its own
- K243301: MapRT (2025), 0 descendants of its own

## Indications for use
Model 1216 Quality Reports is intended for quality assessment of radiotherapy treatment plans and the radiotherapy treatment planning process.

Source page: https://510kreport.com/device/K142142
Methodology: https://510kreport.com/methodology