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Alpha Stereo

by Instrumentarium Corp.

510(k) K934478

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK934478 Date31 Jan 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IZH
Device Class
Class II
Regulation
21 CFR Part 892.1710
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Alpha Stereo is a mammographic X-ray system classified as a Class II medical device. It is designed for use in radiology applications to perform imaging procedures.

This device is identified by the product code IZH and is regulated under 21 CFR 892.1710. It received FDA 510(k) clearance under submission number K934478 on January 31, 1995.

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Questions

AI-generated answers, 24 Sep 2026

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

  • What is the primary use of the Alpha Stereo system?

    The Alpha Stereo is a mammographic X-ray system intended for use in radiology applications to perform diagnostic imaging procedures.

  • What is the regulatory classification of this device?

    The Alpha Stereo is classified as a Class II medical device under 21 CFR 892.1710. It received FDA 510(k) clearance on January 31, 1995, under submission number K934478.

  • Which product code is associated with the Alpha Stereo?

    The device is identified by the product code IZH, which corresponds to its categorization as a mammographic X-ray system within the radiology medical specialty.