# K101992: 3D Scanner, Model 1230

- Pathway: 510(k) (Traditional)
- Applicant: Sun Nuclear Corp.
- Decided: Oct 1, 2010 after 78 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Iba Rfa-200: named in the summary without a submission number

## Most influential descendants
- K142431: WaterProof PROFILER (2014), 0 descendants of its own

## Indications for use
The 3D Scanner system, model 1230, is intended for radiotherapy dosimetry measurements and export of those 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/K101992
Methodology: https://510kreport.com/methodology