# K980997: PGK Device (Modified)

- Pathway: 510(k) (Traditional)
- Applicant: Pgk, Inc.
- Decided: Sep 28, 1998 after 195 days
- Product code: IWJ (System, Applicator, Radionuclide, Manual)
- Device class: 1
- Regulation: 21 CFR 892.5650
- 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 K905198 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911974: PGK Stereotactic Device, Northern Virginia Radiology and Nuclear Medicine (1991) Summary page 1.
- K905198: Diagnostic Ultrasound System Type 3535, Bruel & Kjaer (1991) Summary page 2.
- K914945: Diagnostic Ultrasound System Type 3535, Modified, Bruel & Kjaer Industri A/S (1992) Summary page 2.

## Indications for use
The PGK device is used to guide needles into precise three-dimensional placement in the human body for diagnostic and therapeutic purposes, including brachytherapy for prostate cancer.

Source page: https://510kreport.com/device/K980997
Methodology: https://510kreport.com/methodology