Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
The Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer (product code POK) is a Class 2 radiology device intended to assist users in characterizing lesions identified on acquired medical images, regulated under 892.2060. It requires 510(k) clearance and falls within the radiology medical specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- POK
- Device Class
- FDA class 2
- Regulation Number
- 892.2060
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
Definition
Assist users in characterizing lesions identified on acquired medical images
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 22 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K261519 | Sonio Suspect | Jun 04, 2026 | Substantially Equivalent | Sonio |
| K254161 | Automated Aortic Stenosis Software (AutoAS) | Mar 27, 2026 | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC |
| K251769 | RevealAI-Lung | Jan 30, 2026 | Substantially Equivalent | Precision Medical Ventures, Inc. Dba Revealdx |
| K252294 | Fetal EchoScan (v1.2) | Dec 08, 2025 | Substantially Equivalent | Brightheart |
| K250221 | StrokeSENS ASPECTS Software Application | Jul 01, 2025 | Substantially Equivalent | Circle Cardiovascular Imaging, Inc. |
| K251071 | Fetal EchoScan (v1.1) | May 02, 2025 | Substantially Equivalent | Brightheart |
| K243614 | Sonio Suspect | Feb 21, 2025 | Substantially Equivalent | Sonio |
| K243294 | Brainomix 360 e-ASPECTS | Feb 14, 2025 | Substantially Equivalent | Brainomix Limited |
| K242130 | Koios DS | Nov 15, 2024 | Substantially Equivalent | Koios Medical, Inc. |
| K242342 | Fetal EchoScan | Nov 14, 2024 | Substantially Equivalent | Brightheart |
| K241245 | EchoSolv AS | Oct 04, 2024 | Substantially Equivalent | Echo IQ, Ltd. |
| K234141 | AISAP Cardio V1.0 | Aug 01, 2024 | Substantially Equivalent | Aisap |
| K233342 | CINA-ASPECTS | Mar 15, 2024 | Substantially Equivalent | Avicenna.Ai |
| K232156 | Rapid ASPECTS (v3) | Jan 19, 2024 | Substantially Equivalent | Ischemaview, Inc. |
| K221564 | Brainomix 360 e-ASPECTS | Feb 23, 2023 | Substantially Equivalent | Brainomix Limited |
| K221624 | Avenda Health AI Prostate Cancer Planning Software | Nov 22, 2022 | Substantially Equivalent | Avenda Health, Inc. |
| K212616 | Koios DS | Dec 16, 2021 | Substantially Equivalent | Koios Medical, Inc. |
| K202300 | Optellum Virtual Nodule Clinic, Optellum software, Optellum platform | Mar 05, 2021 | Substantially Equivalent | Optellum, Ltd. |
| K201555 | EchoGo Pro | Dec 18, 2020 | Substantially Equivalent | Ultromics, Ltd. |
| K200760 | Rapid ASPECTS | Jun 26, 2020 | Substantially Equivalent | Ischemaview, Inc. |
| K190442 | Koios DS for Breast | Jul 03, 2019 | Substantially Equivalent | Koios Medical, Inc. |
| DEN170022 | QuantX | Jul 19, 2017 | Unknown | Quantitative Insights, Inc. |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.