Product code POK

Device name

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Medical specialty

Radiology

Device class

2

Regulation number

892.2060

Review panel

RA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Assist users in characterizing lesions identified on acquired medical images

Source

FDA openFDA device classification dataset