Qmenta Care Platform Family
Mint Labs, Inc., d/b/a. QMENTAQMENTA Care Platform Family is a software system that helps hospitals and clinicians receive, store, and analyze medical images from CT, MRI, and PET/CT scans. It integrates multiple AI-powered applications to process these images, assisting doctors in diagnosing by providing advanced image analysis and organized data accessible over a network.
Intended Use
QMENTA Care Platform Family is a software medical imaging system used to receive DICOM images and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. It comprises a storage/archiving server for retrieval of DICOM images from CT, MR, and PET/CT modality data from PACS and/or OS-based file storage, and a workflow server that allows integration of legally marketed clinical applications for image analysis.
Technology
QMENTA Care Platform Family operates on standard computer hardware, supporting DICOM image retrieval from PACS and file storage, with a workflow server enabling integration of clinical image analysis applications. These applications are "plugged in" modules geared towards specific types of image analysis, with results saved as DICOM files with overlays, numerical reports, or other outputs viewable on third-party workstations. The system supports flexible hosting including cloud deployment, configurable dataflow, fully DICOM compliant transfers, and a relevancy engine for directing studies to appropriate applications.
Performance
Testing was performed according to internal company procedures and established standards including ISO 14971, AAMI ANSI IEC 62304 and 62366, and FDA General Principles of Software Validation. Verification and validation confirmed device performance meets design intent. Usability testing with at least 15 participants from the intended user population was performed. No animal, biological, electrical safety, or clinical studies were needed. Risk analysis and cybersecurity assessments were completed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/17/2020
9 months - 2
FDA Approval
6/16/2021
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