# K973786: Northwest Radiation Therapy Products, Precision Stepper and  Guide

- Pathway: 510(k) (Traditional)
- Applicant: Nw Radiation Therapy Products
- Decided: Jan 2, 1998 after 88 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 K871413 (1987). 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)
- K875241: Civco Seed Implant Needle Guide, CIVCO Medical Instruments Co., Inc. (1988) Summary page 1.
- K871413: Civco Stepper, CIVCO Medical Instruments Co., Inc. (1987) Summary page 1.

## Indications for use
Condition to be screened, monitored, treated or diagnosed. Prostate gland voluming and treatment of prostate cancer by transperineal brachytherapy The Precision Stepper provides equipment support and guidance for a rectal probe. When used with its Needle Guide, an ultrasonic imaging system, and a rectal probe, the Precision Stepper and Needle Guide System is an accessory to clinical procedures for prostate gland voluming and ultrasound-guided radioactive seed implantation.

Source page: https://510kreport.com/device/K973786
Methodology: https://510kreport.com/methodology