AI-Rad Companion Prostate MR
Siemens Medical Solutions USA Inc.AI-Rad Companion Prostate MR is AI-powered image analysis software designed to assist radiologists in viewing, segmenting, and analyzing prostate MR images to support targeted MR-US fusion biopsies. It automates prostate gland segmentation, allows manual annotation of findings, calculates PSA density, and exports results for biopsy planning, improving workflow and biopsy accuracy for clinicians.
Intended Use
AI-Rad Companion Prostate MR is a post-processing image analysis software that assists clinicians in viewing, manipulating, analyzing and evaluating MR prostate images for US guided MR-US fusion biopsy support. It provides automatic segmentation and quantitative analysis of the prostate gland, manual annotation of relevant findings, and presentation and export of results for further processing and reporting.
Technology
Cloud-based image processing software using artificial intelligence algorithms to automatically segment and quantify prostate volume on MR DICOM images, with manual adjustment and lesion annotation capabilities. It calculates PSA density using input from the clinical user and exports results in DICOM formats compatible with PACS and ultrasound fusion biopsy systems. It interfaces with AI-Rad Companion Engine platform on a cloud-based environment.
Performance
Non-clinical software validation and bench testing demonstrate performance and substantial equivalence to predicate device syngo.MR Applications (K180336). Testing adhered to FDA guidance for medical device software and multiple FDA-recognized consensus standards (IEC 62366-1, ISO 14971:2007, IEC 62304, DICOM standards). Human factor usability and cybersecurity requirements were addressed. No clinical testing was conducted, but verification and validation supported effectiveness and safety.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/27/2019
8 months - 2
FDA Approval
7/30/2020
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