# K981470: Worldwide Medical Technologies Needle Guide

- Pathway: 510(k) (Traditional)
- Applicant: Worldwide Medical Technologies, LLC
- Decided: Jun 19, 1998 after 57 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- 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 the Worldwide Medical Technologies Needle Guide for Lorad Stereotactic Device is to hold the needle in the stereotactic device for precise location of the needle tip in the needle biopsy of the breast. This device is intended to be used with the Lorad Stereotactic Device only.

Source page: https://510kreport.com/device/K981470
Methodology: https://510kreport.com/methodology