# K021360: Scintillating Fiber Dosimeter (SFD), Model MT-SFD-1000

- Pathway: 510(k) (Traditional)
- Applicant: Med-Tec,Inc.
- Decided: Jun 10, 2003 after 406 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The intended use of this device is to act as a quality assurance device to check for the presence of a brachytherapy seed and give indication of dose rate by an audible tone or digital readout on a standard multi meter. The SDF will be used for ‘relative’ dosimetry. The SDF will be used for ‘relative’ dosimetry.

Source page: https://510kreport.com/device/K021360
Methodology: https://510kreport.com/methodology