# K980826: Equidose Solid State Diode Detectors

- Pathway: 510(k) (Traditional)
- Applicant: Cii Mastek, Inc.
- Decided: Jun 1, 1998 after 90 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 K912250 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912250: Isorad (TM) Integral Buildup Photon Diodes, Theta Systems, Inc. (1991) Summary page 1.

## Most influential descendants
- K030175: 2 BASIC (2003), 0 descendants of its own

## Indications for use
The EquiDose™ Solid State Diode Detector is intended to be used for the collection of radiation beam data from radiation-producing machines. For use, simply place the EquiDose™ Detector inside the area where radiation shall be administered. The connector end of the detector should be attached to an electrometer that will receive the current signal produced by the detector. Through processing, this signal will then indicate the radiation quantity.

Source page: https://510kreport.com/device/K980826
Methodology: https://510kreport.com/methodology