FDA product code POK: Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
POK is the FDA product code for computer-assisted diagnostic software for lesions suspicious for cancer. It is a Class II device, regulated under 21 CFR 892.2060 and reviewed by the Radiology panel. FDA has cleared 22 510(k) submissions under POK, 17 in the last five years, from 14 different applicants. The average 510(k) review took 146 days (median 146); 135 days on average over the last three years. 1 De Novo request was granted under it.
Definition
Assist users in characterizing lesions identified on acquired medical images
Classification
| Field | Value |
|---|---|
| Device name | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Device class | Class II |
| Regulation | 21 CFR 892.2060 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for POK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 128 |
| 2020 | 2 | 142 |
| 2021 | 2 | 162 |
| 2022 | 1 | 169 |
| 2023 | 1 | 268 |
| 2024 | 6 | 156 |
| 2025 | 5 | 106 |
| 2026 | 4 | 142 |
Compare with all 510(k) review times · Search every POK clearance
Top POK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Koios Medical, Inc. | 4 | 2026-07-02 |
| Brightheart | 3 | 2025-12-08 |
| Sonio | 2 | 2026-06-04 |
| Brainomix Limited | 2 | 2025-02-14 |
| Ischemaview, Inc. | 2 | 2024-01-19 |
9 more applicants have POK clearances. See the full list in Caduvo.
Most recent POK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253884 | Koios Medical, Inc. | Koios DS (3.8) | 2026-07-02 | 210 |
| K261519 | Sonio | Sonio Suspect | 2026-06-04 | 28 |
| K254161 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | Automated Aortic Stenosis Software (AutoAS) | 2026-03-27 | 95 |
| K251769 | Precision Medical Ventures, Inc. Dba Revealdx | RevealAI-Lung | 2026-01-30 | 234 |
| K252294 | Brightheart | Fetal EchoScan (v1.2) | 2025-12-08 | 138 |
Recalls for POK devices
openFDA lists no recalls for product code POK.
Frequently asked questions
What is FDA product code POK?
POK is the FDA product code for computer-assisted diagnostic software for lesions suspicious for cancer. It is a Class II device, regulated under 21 CFR 892.2060 and reviewed by the Radiology panel.
What device class is POK?
Class II, regulation 21 CFR 892.2060. Typical premarket route: 510(k).
How long does a 510(k) take for product code POK?
Across 22 cleared submissions the average was 146 days from receipt to decision (median 146).
Which companies have the most POK clearances?
Koios Medical, Inc. (4); Brightheart (3); Sonio (2); Brainomix Limited (2); Ischemaview, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code POK
- Run a recall and safety report across every POK manufacturer
- Watch product code POK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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