QyScore Software
by Qynapse France EUDAMED510(k)
510(k) K192531
Product code LLZ
Overview
QyScore Software is a diagnostic imaging analysis tool designed to assist in the evaluation of radiologic images, specifically within the domain of radiology. It functions as a decision-support system to enhance diagnostic accuracy and efficiency by processing and interpreting imaging data.
The software is supplied as a digital solution, intended for use in clinical radiology settings. It operates on standard computing platforms and does not require sterilization or physical handling, aligning with single-use digital standards. Authorized under FDA 510K clearance, MDD, and MDR compliance, it is classified under product code LLZ and is regulated as a substantially equivalent device to existing standards in radiology diagnostics.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK192531 | Date13 Dec 2019 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
Specification
- 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
Other devices from Qynapse
Questions
What clinical setting is QyScore Software designed for and how does it improve diagnostic workflows?
QyScore Software is designed specifically for clinical radiology settings where radiologists evaluate imaging data. It serves as a decision-support tool to enhance diagnostic accuracy and efficiency by processing and interpreting radiologic images. Since it operates digitally on standard computing platforms, it integrates seamlessly into existing workflows without requiring physical handling or sterilization, reducing potential delays and human error in interpretation.
Is QyScore Software reusable or single-use, and how is it supplied?
QyScore Software is a digital solution and follows single-use digital standards, meaning it is not physically reusable like traditional medical devices. It is supplied entirely as software, requiring no physical packaging or sterilization—just installation on authorized computing platforms in clinical radiology environments.
What regulatory pathways does QyScore Software follow, and how does that affect its use?
QyScore Software is authorized under FDA 510(k) clearance, MDD, and MDR compliance, ensuring it meets stringent regulatory standards for diagnostic imaging tools. Its classification under product code LLZ (Radiology) and designation as substantially equivalent to existing standards confirms its alignment with established diagnostic practices, providing confidence in its clinical validity and safety for use in radiology workflows.
Does QyScore Software require any special storage conditions, and how is it maintained?
Since QyScore Software is a digital tool, it does not require physical storage like traditional medical devices. However, it must be installed on compliant computing platforms within clinical radiology settings to ensure proper functionality. Maintenance involves routine software updates and system checks to sustain performance, as outlined by the manufacturer’s guidelines.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K192531
- EUDAMED