# K990734: DPD-12PCC

- Pathway: 510(k) (Special)
- Applicant: Scanditronix Medical AB
- Decided: May 28, 1999 after 84 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 K925133 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942092: DPD-3, Scanditronix, Inc. (1994) Summary page 1.
- K925133: DPD-510 Therapeutic Radiation Dosimeter, Scanditronix, Inc. (1993) Summary page 1.

## Indications for use
The DPD-12PC Direct Patient Dosemeter is used - to monitor radiation dosage to a patient during radiotherapy procedure - for quality control measurements of therapeutic radiation devices

Source page: https://510kreport.com/device/K990734
Methodology: https://510kreport.com/methodology