Bot Image, Inc.

Device typeMRI image interpretive software: An interpretive software program intended to be used to analyse magnetic resonance imaging (MRI) data (e.g., prostate MRI) to detect and localize suspected abnormalities and sometimes provide results as clinically relevant tags; it may additionally be intended for three-dimensional (3-D) model creation slice-based images (segmentation). It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].

FDA categoryRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Device ID00860009082618

Catalog number580SW.01

AvailabilityPrescription

MRI safetyLabeling does not contain MRI Safety Information