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System, X-Ray, Mammographic

by Technowipe

510(k) K936161

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 NumberK936161 Date4 May 1994ClearedStatusActive

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  • Withdrawn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)

Full name
System, X-Ray, Mamographic
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, 21 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 System, X-Ray, Mammographic is a device used to produce radiographs of the breast. It may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. This device is classified as a Class II mammography system.

The System, X-Ray, Mammographic is supplied with a product code of IZH and is regulated under regulation number 892.1710. It has been assigned a device class of 2 and has received FDA 510(k) clearance, with a decision date of 1994-05-04. The device is used in the field of Radiology.

Questions

AI-generated answers, 21 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 System, X-Ray, Mammographic used for?

    The System, X-Ray, Mammographic is used to produce radiographs of the breast, which is a crucial tool in the field of Radiology.

  • What type of clearance has the System, X-Ray, Mammographic received?

    The System, X-Ray, Mammographic has received FDA 510(k) clearance, indicating that it is substantially equivalent to a predicate device.

  • What is the product code for the System, X-Ray, Mammographic?

    The product code for the System, X-Ray, Mammographic is IZH, and it is regulated under regulation number 892.1710.