510(k) K230096

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

May 23, 2023

Date Received

January 13, 2023

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Device Class

Class II

Regulation Number

892.2090

Review Panel

RA

Submission Type

A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion to the user. Primary diagnostic and patient management decisions are made by the clinical user.