Avenda Health AI Prostate Cancer Planning Software
FDA 510(k) clearance K221624 · decided 2022-11-22
Clearance details
- K-number
- K221624
- Device name
- Avenda Health AI Prostate Cancer Planning Software
- Applicant
- Avenda Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-06
- Decision date
- 2022-11-22
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- POK
- Device class
- 2
- Regulation number
- 892.2060
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Culver City, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
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| 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.