# K980402: Capintec Model 292 Electrometer

- Pathway: 510(k) (Traditional)
- Applicant: Capintec, Inc.
- Decided: Apr 24, 1998 after 81 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) Capintec Model 192 Electrometer: named in the summary without a submission number
- (no number) CRC 15R dose calibrator: named in the summary without a submission number

## Indications for use
THE CAPINTEC 292 ELECTROMETER IS INTENDED TO BE USED BY TRAINED MEDICAL PHYSICISTS OR QUALIFIED RADIATION THERAPY TECHNOLOGISTS TO PERFORM QUALITY ASSURANCE CHECKS AND MEASUREMENTS ON THE OUTPUT FROM THERAPEUTIC X-RAY MACHINES OR TELETHERAPY UNITS. WITH THE ADDITION OF AN OPTIONAL CAPINTEC CRC DOSE CALIBRATOR CHAMBER, THE 292 MAY ALSO BE USED BY TRAINED MEDICAL PHYSICISTS OR QUALIFIED TECHNOLOGISTS TO MEASURE RADIOACTIVE SOURCES USED FOR THERAPEUTIC OR DIAGNOSTIC TREATMENT.

Source page: https://510kreport.com/device/K980402
Methodology: https://510kreport.com/methodology