Koios DS
FDA 510(k) clearance K212616 · decided 2021-12-16
Clearance details
- K-number
- K212616
- Device name
- Koios DS
- Applicant
- Koios Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-08-18
- Decision date
- 2021-12-16
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- POK
- Device class
- 2
- Regulation number
- 892.2060
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Koios DS (3.8) (K253884) | Koios Medical, Inc. | 2026-07-02 |
| Sonio Suspect (K261519) | Sonio | 2026-06-04 |
| Automated Aortic Stenosis Software (AutoAS) (K254161) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026-03-27 |
| RevealAI-Lung (K251769) | Precision Medical Ventures, Inc. Dba Revealdx | 2026-01-30 |
| Fetal EchoScan (v1.2) (K252294) | Brightheart | 2025-12-08 |
| StrokeSENS ASPECTS Software Application (K250221) | Circle Cardiovascular Imaging, Inc. | 2025-07-01 |
| Fetal EchoScan (v1.1) (K251071) | Brightheart | 2025-05-02 |
| Sonio Suspect (K243614) | Sonio | 2025-02-21 |
| Brainomix 360 e-ASPECTS (K243294) | Brainomix Limited | 2025-02-14 |
| Koios DS (K242130) | Koios Medical, Inc. | 2024-11-15 |
| Fetal EchoScan (K242342) | Brightheart | 2024-11-14 |
| EchoSolv AS (K241245) | Echo IQ, Ltd. | 2024-10-04 |
Recalls involving this device
No recalls on record reference this clearance.