POK — Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer Class II
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 |
|---|---|---|---|
| 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 |
| K200760 | ischemaview | Rapid ASPECTS | June 26, 2020 |
| K190442 | koios medical | Koios DS for Breast | July 3, 2019 |
| DEN170022 | quantitative insights | QuantX | July 19, 2017 |