Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Regulation 892.2060
6510(k)s in 12 months (24 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in POK
| Company | 510(k)s | Recalls |
|---|---|---|
| Koios Medical, Inc. | 4 | 0 |
| Brightheart | 3 | 0 |
| Brainomix Limited | 2 | 0 |
| Ischemaview, Inc. | 2 | 0 |
| Sonio | 2 | 0 |
| Aisap | 1 | 0 |
| Avenda Health, Inc. | 1 | 0 |
| Avicenna.Ai | 1 | 0 |
| Circle Cardiovascular Imaging, Inc. | 1 | 0 |
| Deep Breathe, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 2026 | K261679 | BlineSlide Deep Breathe, Inc., CA | POK |
| Jul 2, 2026 | K253884 | Koios DS (3.8) Koios Medical, Inc. | POK |
| Jun 4, 2026 | K261519 | Sonio Suspect Sonio, FR | POK |
| Mar 27, 2026 | K254161 | Automated Aortic Stenosis Software (AutoAS) GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | POK |
| Jan 30, 2026 | K251769 | RevealAI-Lung Precision Medical Ventures, Inc. Dba Revealdx | POK |
| Dec 8, 2025 | K252294 | Fetal EchoScan (v1.2) Brightheart, FR | POK |
| Jul 1, 2025 | K250221 | StrokeSENS ASPECTS Software Application Circle Cardiovascular Imaging, Inc., CA | POK |
| May 2, 2025 | K251071 | Fetal EchoScan (v1.1) Brightheart, FR | POK |
| Feb 21, 2025 | K243614 | Sonio Suspect Sonio, FR | POK |
| Feb 14, 2025 | K243294 | Brainomix 360 e-ASPECTS Brainomix Limited, GB | POK |
| Nov 15, 2024 | K242130 | Koios DS Koios Medical, Inc. | POK |
| Nov 14, 2024 | K242342 | Fetal EchoScan Brightheart, FR | POK |
| Oct 4, 2024 | K241245 | EchoSolv AS Echo IQ, Ltd., AU | POK |
| Aug 1, 2024 | K234141 | AISAP Cardio V1.0 Aisap, IL | POK |
| Mar 15, 2024 | K233342 | CINA-ASPECTS Avicenna.Ai, FR | POK |
| Jan 19, 2024 | K232156 | Rapid ASPECTS (v3) Ischemaview, Inc. | POK |
| Feb 23, 2023 | K221564 | Brainomix 360 e-ASPECTS Brainomix Limited, GB | POK |
| Nov 22, 2022 | K221624 | Avenda Health AI Prostate Cancer Planning Software Avenda Health, Inc. | POK |
| Dec 16, 2021 | K212616 | Koios DS Koios Medical, Inc. | POK |
| Mar 5, 2021 | K202300 | Optellum Virtual Nodule Clinic, Optellum software, Optellum platform Optellum, Ltd., GB | POK |
| Dec 18, 2020 | K201555 | EchoGo Pro Ultromics, Ltd., GB | POK |
| Jun 26, 2020 | K200760 | Rapid ASPECTS Ischemaview, Inc. | POK |
| Jul 3, 2019 | K190442 | Koios DS for Breast Koios Medical, Inc. | POK |
| Jul 19, 2017 | DEN170022 | QuantX Quantitative Insights, Inc. | POK |
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