POK · Class II · 21 CFR 892.2060

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 Ischemaview, Inc..

1
Total
1
Cleared
183d
Avg days
2024
Since

List of Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer devices cleared through 510(k)

1 devices
1–1 of 1

How to use this database

This page lists all FDA 510(k) submissions for Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer devices (product code POK). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Radiology FDA review panel. Browse all Radiology devices →