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Giotto Class (Models 3000X-YY and 4000X-YY)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K200424

by Ims Giotto S.P.A.

Identifiers

510(k) Number
K200424 FDA 510(k)
FDA Product Code
MUE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1715 FDA 510(k)
Regulation Number
892.1715 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Giotto Class (Models 3000X-YY and 4000X-YY) is a Full Field Digital X-Ray Mammographic System, designed for high-resolution imaging of breast tissue. As a Class II medical device, it provides full-field digital mammography with advanced detection capabilities for early breast cancer screening and diagnosis.

This system is intended for use in radiology departments and imaging centers, supplied as a reusable device with appropriate sterilization protocols. It operates under FDA 510(k) clearance, IVDR, and MDR authorizations, adhering to regulatory standards for mammographic imaging. The device is not single-use and requires proper storage and maintenance to ensure consistent performance and image quality.

Frequently asked questions

What types of imaging tasks is the Giotto Class system designed to support in a clinical setting?

The Giotto Class system is specifically designed for high-resolution imaging of breast tissue, making it ideal for full-field digital mammography. This includes both screening and diagnostic evaluations for early detection and assessment of breast cancer, ensuring detailed visualization of breast structures for radiologists.

How is the Giotto Class system supplied and what are the requirements for its use?

The Giotto Class system is a reusable device, meaning it is not single-use and requires proper sterilization protocols between uses. It is intended for installation in radiology departments and imaging centers, where it must be maintained and stored according to manufacturer guidelines to ensure consistent performance and image quality.

What regulatory pathways does the Giotto Class system follow, and how does this affect its use?

The Giotto Class system follows FDA 510(k) clearance, as well as IVDR (In Vitro Diagnostic Regulation) and MDR (Medical Device Regulation) authorizations. These pathways ensure compliance with stringent safety and performance standards, allowing its use in regulated healthcare environments where mammographic imaging is required for breast cancer screening and diagnosis.

Are there different models available for the Giotto Class system, and if so, how do they differ?

Yes, the Giotto Class system includes two primary models: the 3000X-YY and the 4000X-YY. While the exact differences between these models are not specified in the data, they are both classified as full-field digital X-ray mammographic systems, likely varying in technical specifications or features to cater to different clinical or operational needs.

What kind of maintenance or storage considerations should be taken into account for the Giotto Class system?

Since the Giotto Class system is reusable, it requires proper storage and maintenance protocols to preserve its performance and ensure image quality. This includes regular servicing, calibration, and adherence to manufacturer guidelines for cleaning and sterilization to prevent contamination and equipment degradation over time.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ims Giotto S.P.A.

Sources (2)

  • FDA 510(k) K200424 24 fields · synced Oct 7, 2026
  • EUDAMED 1 fields · synced Jun 18, 2026