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FDA-cleared K191556

Red Dot

Behold.AI Technologies Limited

Authorized purpose: The red dot software platform is a software workflow tool designed to aid the clinical assessment of adult chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment. Red dot analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. red dot is not intended to direct attention to specific portions basis for clinical decision-making nor is it intended to rule out Pneumothorax or otherwise preclude clinical assessment of X-Ray cases.

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2020-02-28