What is the Eureka Extension Cylinders device used for?

The Eureka Extension Cylinders are used in a diagnostic setting, specifically in radiology for beam limiting.

What is the regulatory classification of the Eureka Extension Cylinders?

The device is classified as a Class 2 medical device and has been issued FDA 510(k) clearance.

How is the Eureka Extension Cylinders device supplied?

The device is supplied with a product code of KPW and is regulated under regulation number 892.1610.

Eureka Extension Cylinders

by Eureka X-Ray Tube Corp. 510(k)

Active United States

510(k) K904489

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK904489	Date15 Oct 1990Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number: K904489
FDA Product Code: KPW

Device Class: Class II
Regulation: 21 CFR Part 892.1610
Advisory Committee: Radiology
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Eureka Extension Cylinders are a Device, Beam Limiting, X-Ray, Diagnostic, used in radiology. They are classified as a Class 2 medical device. The device is substantially equivalent to other devices on the market.

The Eureka Extension Cylinders are supplied with a product code of KPW and are regulated under regulation number 892.1610. They have been issued FDA 510(k) clearance, with a decision date of 1990-10-15. The device is intended for use in a diagnostic setting, specifically in radiology.

Other devices from Eureka X-Ray Tube Corp.

Eureka X-Scan 150 X-Ray Tube Housing As.

Class I

Questions

AI-generated answers, 22 Sep 2026