Identifiers
- 510(k) Number
- K181704 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 is a Class II radiological computer-assisted detection and diagnosis software designed to identify lesions suspicious for cancer in imaging studies. It leverages advanced algorithms to enhance radiologist workflow by flagging potential abnormalities in mammograms, CT scans, and other radiographic modalities for further evaluation.
The software is supplied as a digital tool integrated into radiology workstations and requires no physical storage or sterilisation. It operates in MRI-safe environments and is intended for single-use per imaging session, though the underlying software license may allow repeated use across multiple studies. Authorised under FDA 510(k) clearance, MDD, and MDR compliance, it adheres to regulatory standards for diagnostic imaging software in radiology settings.
Frequently asked questions
How does Transpara integrate into existing radiology workflows and what imaging modalities does it support for lesion detection?
Transpara integrates directly into radiology workstations as a digital software tool, requiring no additional hardware or physical storage. It is designed to enhance workflow by analyzing mammograms, CT scans, and other radiographic imaging modalities to flag potential abnormalities suspicious for cancer. The software’s algorithmic focus ensures it can be used alongside standard imaging equipment without requiring modifications to existing systems.
Is Transpara intended for repeated use across multiple imaging sessions, or is it designed for single-use per study?
Transpara itself is intended for single-use per imaging session, meaning it is applied to analyze one study at a time. However, the underlying software license allows for repeated use across multiple studies, meaning the software can be activated and utilized for different imaging sessions as needed, provided it remains integrated into the radiology workstation.
Does Transpara require any special handling or storage conditions, such as sterilization or environmental compatibility?
Since Transpara is a digital software tool, it does not require physical storage, sterilization, or specialized handling like traditional medical devices. It operates in MRI-safe environments and is compatible with standard radiology workstations, ensuring no additional logistical considerations beyond ensuring the workstation meets the software’s technical requirements.
What regulatory pathways has Transpara undergone, and how does this affect its use in clinical settings?
Transpara has been authorized through FDA 510(k) clearance, as well as compliance with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). These pathways confirm its substantial equivalence to existing radiological computer-assisted detection software and adherence to safety and performance standards. Clinicians can rely on its regulatory approvals to ensure it meets established benchmarks for diagnostic imaging software in radiology.
Are there different versions or sizes of Transpara, or is it a single unified software solution?
Transpara is a unified software solution designed for integration into radiology workstations without variations in size or model. Its functionality is consistent across all supported imaging modalities, and there are no physical or version-specific differences—only the underlying software license governs its repeated use across studies.
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
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K181704 | Class II | Active |
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Manufacturer
- Manufacturer
- Screenpoint Medical B.V.
Sources (2)
- FDA 510(k) K181704 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026