# K954564: Pid-1 Precision Intelligent Dosimeter

- Pathway: 510(k) (Traditional)
- Applicant: Gammex, Inc.
- Decided: Apr 22, 1996 after 203 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 K931927 (1993). 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)
- K931927: Victoreen Model 530, Victoreen, Inc. (1993) Summary page 1.

## Indications for use
This device is intended to be used for precision measurement of ionizing radiation beams.

Source page: https://510kreport.com/device/K954564
Methodology: https://510kreport.com/methodology