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6 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Lunit, Inc.
Authorized purpose: Lunit INSIGHT MMG v1.1.10 aids physicians in detection, localization and characterization of suspicious breast-cancer areas on female screening mammograms from compatible FFDM systems, viewed after the physician's initial read as an adjunct to complete clinical interpretation.
Lunit, Inc.
Authorized purpose: Concurrent CADe/x aid for interpreting physicians to detect and characterize breast-cancer-suspicious lesions in screening DBT exams from compatible systems, marking soft-tissue lesions and calcifications with abnormality scores.
Lunit Inc.
Authorized purpose: Concurrent CADe/x aid for interpreting physicians to detect and characterize breast-cancer-suspicious lesions in screening DBT exams from compatible systems.
Lunit Inc.
Authorized purpose: Concurrent CADe/x aid for interpreting physicians to detect and characterize suspected breast-cancer lesions in screening DBT exams from compatible systems.
Lunit Inc.
Authorized purpose: Aid interpreting physicians in detecting, localizing, and characterizing suspicious breast-cancer areas on mammograms from compatible FFDM systems, viewed after the physician completes the initial read.
Lunit Inc.
Authorized purpose: Passively triage adult chest radiographs for suspected pleural effusion and/or pneumothorax.