510(k) K190442
- Device
- Koios DS For Breast
- Applicant
- Koios Medical, Inc.
- 510(k) number
- K190442
- Product code
- POK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-07-03
- Date received
- 2019-02-25
- Regulation
- 892.2060
- Classification name
- Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lev Barinov
- Address
- 500 7th Ave., 8th Floor New York NY US 10018 10018
FDA Registration Numbers#
- 3017604664
- 3040335643
- 3007301305
- 3022983474
- 3033588305
- 3034527804
- 3016585383
- 3010119782
- 3044622018
- 3017210169
- 3029937167
- 3015478020
- 3011205675
- 3032008018
Source Documents#
Other 510(k) Records For Product Code POK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254161 | Automated Aortic Stenosis Software (AutoAS) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026-03-27 |
| K251769 | RevealAI-Lung | Precision Medical Ventures, Inc. Dba Revealdx | 2026-01-30 |
| K252294 | Fetal EchoScan (v1.2) | Brightheart | 2025-12-08 |
| K250221 | StrokeSENS ASPECTS Software Application | Circle Cardiovascular Imaging, Inc. | 2025-07-01 |
| K251071 | Fetal EchoScan (v1.1) | Brightheart | 2025-05-02 |
| K243614 | Sonio Suspect | Sonio | 2025-02-21 |
| K243294 | Brainomix 360 e-ASPECTS | Brainomix Limited | 2025-02-14 |
| K242130 | Koios DS | Koios Medical, Inc. | 2024-11-15 |
| K242342 | Fetal EchoScan | Brightheart | 2024-11-14 |
| K241245 | EchoSolv AS | Echo IQ, Ltd. | 2024-10-04 |
| K234141 | AISAP Cardio V1.0 | Aisap | 2024-08-01 |
| K233342 | CINA-ASPECTS | Avicenna.Ai | 2024-03-15 |
| K232156 | Rapid ASPECTS (v3) | Ischemaview, Inc. | 2024-01-19 |
| K221564 | Brainomix 360 e-ASPECTS | Brainomix Limited | 2023-02-23 |
| K221624 | Avenda Health AI Prostate Cancer Planning Software | Avenda Health, Inc. | 2022-11-22 |
Legacy Summary#
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FDA Review#
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