# K051921: The Edge Detector, Model 1118

- Pathway: 510(k) (Traditional)
- Applicant: Sun Nuclear Corp.
- Decided: Jul 27, 2005 after 12 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.
No later device cites it as a predicate yet.
0 of 1 device 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) PTW Dosimetry Diode: named in the summary without a submission number
- (no number) PTW Pinpoint Type Ionization Chamber: named in the summary without a submission number

## Indications for use
The Edge™ Detector is a device that is designed for use as a radiation scanning detector in any water tank scanning system that is used to measure beam data in radiotherapy departments for dose modeling in the treatment planning computer.

Source page: https://510kreport.com/device/K051921
Methodology: https://510kreport.com/methodology