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Transpara 1.7.2

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K221347

by Screenpoint Medical B.V.

Identifiers

510(k) Number
K221347 FDA 510(k)
FDA Product Code
QDQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2090 FDA 510(k)
Regulation Number
892.2090 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Transpara 1.7.2 is a Radiological Computer Assisted Detection/Diagnosis Software for Lesions Suspicious for Cancer, designed to enhance the identification and assessment of potential malignant findings in radiographic imaging. It leverages advanced algorithms to assist radiologists in detecting abnormalities within breast, lung, and other high-risk lesion types, improving diagnostic accuracy and workflow efficiency.

This software is supplied as a digital tool for use in radiology departments, requiring integration with existing imaging systems to process and analyze scans. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance, MDD, and MDR authorizations. No sterility or single-use requirements apply, as it operates as a reusable software solution compatible with standard IT infrastructure, with no specific MRI safety considerations.

Frequently asked questions

What types of imaging scans does the Transpara 1.7.2 software assist radiologists in analyzing for potential cancerous lesions?

The Transpara 1.7.2 software is designed to assist radiologists in detecting and assessing abnormalities suspicious for cancer in breast and lung imaging, as well as other high-risk lesion types. It uses advanced algorithms to enhance identification and diagnostic accuracy within radiographic scans, improving workflow efficiency for these specific areas.

How is the Transpara 1.7.2 software supplied and what system requirements does it have?

The Transpara 1.7.2 is supplied as a digital software solution and does not require physical packaging or sterility. It must be integrated with existing imaging systems in radiology departments to process and analyze scans. Since it operates as a reusable software tool, it is compatible with standard IT infrastructure and does not have specific hardware or MRI safety requirements.

Is the Transpara 1.7.2 software intended for single-use or repeated use across multiple patients?

The Transpara 1.7.2 software is not single-use—it is designed for repeated use within radiology departments. As a reusable digital tool, it can be utilized across multiple patients and imaging sessions without replacement, provided it remains properly maintained and updated.

What regulatory pathways has the Transpara 1.7.2 software undergone, and which governing bodies have authorized its use?

The Transpara 1.7.2 has undergone FDA 510(k) clearance, as well as authorization under the Medical Device Directive (MDD) and Medical Device Regulation (MDR). These pathways confirm its compliance with regulatory standards for radiological computer-assisted detection/diagnosis software in the U.S. and EU markets.

Does the Transpara 1.7.2 software require any special storage conditions or maintenance beyond standard IT infrastructure?

Since the Transpara 1.7.2 is a software-based solution, it does not require physical storage conditions like temperature or humidity control. However, it must be properly installed on compliant IT systems and regularly updated to ensure optimal performance and compliance with regulatory requirements. No additional maintenance beyond standard software upkeep is specified.

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

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Screenpoint Medical B.V.

Sources (2)

  • FDA 510(k) K221347 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026