POK — Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer Class II
FDA product code POK covers "Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer", a Class II medical device regulated under 21 CFR 892.2060. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- POK
- Device Class
- Class II
- Regulation Number
- 892.2060
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Definition
Assist users in characterizing lesions identified on acquired medical images
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253884 | koios medical | Koios DS (3.8) | July 2, 2026 |
| K261519 | sonio | Sonio Suspect | June 4, 2026 |
| K254161 | ge medical systems ultrasound and primary care diagnostics | Automated Aortic Stenosis Software (AutoAS) | March 27, 2026 |
| K251769 | precision medical ventures, inc. dba revealdx | RevealAI-Lung | January 30, 2026 |
| K252294 | brightheart | Fetal EchoScan (v1.2) | December 8, 2025 |
| K250221 | circle cardiovascular imaging | StrokeSENS ASPECTS Software Application | July 1, 2025 |
| K251071 | brightheart | Fetal EchoScan (v1.1) | May 2, 2025 |
| K243614 | sonio | Sonio Suspect | February 21, 2025 |
| K243294 | brainomix limited | Brainomix 360 e-ASPECTS | February 14, 2025 |
| K242130 | koios medical | Koios DS | November 15, 2024 |
| K242342 | brightheart | Fetal EchoScan | November 14, 2024 |
| K241245 | echo iq | EchoSolv AS | October 4, 2024 |
| K234141 | aisap | AISAP Cardio V1.0 | August 1, 2024 |
| K233342 | avicenna.ai | CINA-ASPECTS | March 15, 2024 |
| K232156 | ischemaview | Rapid ASPECTS (v3) | January 19, 2024 |
| K221564 | brainomix limited | Brainomix 360 e-ASPECTS | February 23, 2023 |
| K221624 | avenda health | Avenda Health AI Prostate Cancer Planning Software | November 22, 2022 |
| K212616 | koios medical | Koios DS | December 16, 2021 |
| K202300 | optellum | Optellum Virtual Nodule Clinic, Optellum software, Optellum platform | March 5, 2021 |
| K201555 | ultromics | EchoGo Pro | December 18, 2020 |