FDA-cleared K222174

RadioLens v1.0

Synapsica

RadioLens v1.0 is a medical diagnostic application for displaying, processing, storing, and transferring DICOM data other than mammography, with filtering, digital manipulation,...

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