FDA Product Code POK: Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Assist Users In Characterizing Lesions Identified On Acquired Medical Images
Leading manufacturers include Brightheart, Brainomix Limited and Ischemaview, Inc..
FDA 510(k) Cleared Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer Devices (Product Code POK)
About Product Code POK - Regulatory Context
510(k) Submission Activity
21 total 510(k) submissions under product code POK since 2017, with 20 receiving FDA clearance (average review time: 146 days).
Submission volume has increased in recent years - 11 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under POK have taken an average of 131 days to reach a decision - down from 163 days historically, suggesting improved FDA processing for this classification.
POK devices are reviewed by the Radiology panel. Browse all Radiology devices →