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MammoWorkstation

by Image Diagnost International GmbH

510(k) K123575

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 NumberK123575 Date19 Feb 2013ClearedStatusActive

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  • Withdrawn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
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The MammoWorkstation is a diagnostic imaging workstation designed for radiologists to review and analyze multi-modality softcopy images in mammography. It facilitates primary diagnostic evaluation for both screening and diagnostic procedures by enabling flexible and interactive manipulation of digital images. As a Class II X-ray system, it integrates advanced imaging tools tailored for breast cancer detection and assessment.

This device is intended for use in radiology departments and is supplied as a reusable medical imaging workstation. It is not described as sterile or single-use, and no MRI safety information is provided. The system is authorized under FDA 510(k) clearance (K123575) and falls under the product code LLZ, classified under the Radiology advisory committee. Storage and handling instructions are not specified in the regulatory data.

Other devices from Image Diagnost International GmbH

Questions

AI-generated answers, 1 Oct 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 MammoWorkstation used for?

    The MammoWorkstation is designed specifically for radiologists to review and analyze multi-modality softcopy images in mammography. It supports both screening and diagnostic procedures by allowing flexible, interactive manipulation of digital images, which helps improve breast cancer detection and assessment accuracy.

  • Is the MammoWorkstation reusable or single-use?

    The MammoWorkstation is supplied as a reusable medical imaging workstation. Unlike single-use devices, it is intended for repeated use in radiology departments after proper cleaning and maintenance, ensuring long-term reliability for diagnostic workflows.

  • What type of regulatory clearance does the MammoWorkstation hold?

    The MammoWorkstation holds FDA 510(k) clearance under the reference number K123575. It is classified as a Class II X-ray system and falls under the Radiology advisory committee, indicating it meets regulatory standards for diagnostic imaging safety and performance.

  • Does the MammoWorkstation require sterile handling?

    No, the MammoWorkstation is not described as a sterile device. It is intended for use in radiology departments where standard infection control practices apply, but it does not require sterile packaging or handling like surgical instruments.

  • What are the key features distinguishing the MammoWorkstation?

    The MammoWorkstation stands out for its integration of advanced imaging tools tailored for mammography, enabling radiologists to perform primary diagnostic evaluations with interactive image manipulation. Its reusable design and multi-modality support make it versatile for both screening and diagnostic breast imaging procedures.