# K042698: Unfors Patient Skin Dosimeter (PSD)

- Pathway: 510(k) (Traditional)
- Applicant: Unfors, Inc.
- Decided: Oct 22, 2004 after 22 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- 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 K961105 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961105: Skin Dose Monitor, Mcmahon Medical (1996) Summary page 1.

## Indications for use
Measure patient entrance skin dose in real time during fluoroscopy / computerized tomography (CT) procedures. It can be equipped with 1-4 sensors.

Source page: https://510kreport.com/device/K042698
Methodology: https://510kreport.com/methodology