Synapsica radiology AI products

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FDA-cleared K222174

RadioLens v1.0

Synapsica

Authorized purpose: RadioLens v1.0 is a medical diagnostic application for displaying, processing, storing, and transferring DICOM data other than mammography, with filtering, digital manipulation, and quantitative measurements; its optional SpindleX module analyzes potential vertebral displacement in adult cervical or lumbar spine stress X-rays and calculates measurements related to spinal-ligament injury leading to subluxation.

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Spine, including cervical and lumbar vertebrae; general DICOM images excluding mammography
Decision: 2023-03-28