# K030175: 2 BASIC

- Pathway: 510(k) (Traditional)
- Applicant: Capintec, Inc.
- Decided: Apr 17, 2003 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: 2 generations back to K912250 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912249: Patient Dose Monitor, Theta Systems, Inc. (1991) Summary page 2.
- K912250: Isorad (TM) Integral Buildup Photon Diodes, Theta Systems, Inc. (1991) Summary page 2.
- K980826: Equidose Solid State Diode Detectors, Cii Mastek, Inc. (1998) Summary page 2.

## Indications for use
The 2 Basic is a solid state diode detector system coupled with a precision electrometer and PC for radiation measurement, data storage and display. It is intended to be used by trained medical physicists for the measurement of radiation output from radiation therapy treatment machines. The 2 Basic can be used with direct patient contact for entrance skin measurements, or in air, water, or other suitable phantoms materials for beam output measurements. Measurement data is used to verify and document the beam characteristics of radiation therapy treatment machines for quality assurance programs and to very therapeutic doses delivered to patients during treatments.

Source page: https://510kreport.com/device/K030175
Methodology: https://510kreport.com/methodology