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 Brightheart, Koios Medical, Inc. and Sonio.

23
Total
22
Cleared
144d
Avg days
2017
Since
Growing category - 12 submissions in the last 2 years vs 5 in the prior period
Review times improving: avg 122d recently vs 168d historically

FDA 510(k) Cleared Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer Devices (Product Code POK)

23 devices
1–23 of 23
Cleared Jun 04, 2026
Sonio Suspect
K261519
Sonio
Radiology · 28d
Cleared Mar 27, 2026
Automated Aortic Stenosis Software (AutoAS)
K254161
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Radiology · 95d
Cleared Jan 30, 2026
RevealAI-Lung
K251769
Precision Medical Ventures, Inc. Dba Revealdx
Radiology · 234d
Cleared Dec 08, 2025
Fetal EchoScan (v1.2)
K252294
Brightheart
Radiology · 138d
Cleared Jul 01, 2025
StrokeSENS ASPECTS Software Application
K250221
Circle Cardiovascular Imaging, Inc.
Radiology · 158d
Cleared May 02, 2025
Fetal EchoScan (v1.1)
K251071
Brightheart
Radiology · 25d
Cleared Feb 21, 2025
Sonio Suspect
K243614
Sonio
Radiology · 91d
Cleared Feb 14, 2025
Brainomix 360 e-ASPECTS
K243294
Brainomix Limited
Radiology · 119d
Cleared Nov 15, 2024
Koios DS
K242130
Koios Medical, Inc.
Radiology · 116d
Cleared Nov 14, 2024
Fetal EchoScan
K242342
Brightheart
Radiology · 99d
Cleared Oct 04, 2024
EchoSolv AS
K241245
Echo IQ, Ltd.
Radiology · 154d
Cleared Aug 01, 2024
AISAP Cardio V1.0
K234141
Aisap
Radiology · 216d
Cleared Mar 15, 2024
CINA-ASPECTS
K233342
Avicenna.Ai
Radiology · 168d
Cleared Jan 19, 2024
Rapid ASPECTS (v3)
K232156
Ischemaview, Inc.
Radiology · 183d
Cleared Feb 23, 2023
Brainomix 360 e-ASPECTS
K221564
Brainomix Limited
Radiology · 268d
Cleared Nov 22, 2022
Avenda Health AI Prostate Cancer Planning Software
K221624
Avenda Health, Inc.
Radiology · 169d
Cleared Dec 16, 2021
Koios DS
K212616
Koios Medical, Inc.
Radiology · 120d
Cleared Mar 05, 2021
Optellum Virtual Nodule Clinic, Optellum software, Optellum platform
K202300
Optellum, Ltd.
Radiology · 204d
Cleared Dec 18, 2020
EchoGo Pro
K201555
Ultromics, Ltd.
Radiology · 191d
Cleared Jun 26, 2020
Rapid ASPECTS
K200760
Ischemaview, Inc.
Radiology · 94d
Cleared Jul 03, 2019
Koios DS for Breast
K190442
Koios Medical, Inc.
Radiology · 128d

About Product Code POK - Regulatory Context

510(k) Submission Activity

23 total 510(k) submissions under product code POK since 2017, with 22 receiving FDA clearance (average review time: 144 days).

Submission volume has increased in recent years - 12 submissions in the last 24 months compared to 5 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - POK Product Code

Recent submissions under POK have taken an average of 122 days to reach a decision - down from 168 days historically, suggesting improved FDA processing for this classification.

POK devices are reviewed by the Radiology panel. Browse all Radiology devices →