STEDI Scan Device
FDA 510(k) clearance K253840 · decided 2026-07-22
Clearance details
- K-number
- K253840
- Device name
- STEDI Scan Device
- Applicant
- Stroke DX
- Decision
- Substantially Equivalent
- Date received
- 2025-12-01
- Decision date
- 2026-07-22
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- QAF
- Device class
- 2
- Regulation number
- 870.2770
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Culver City, CA, 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 |
|---|---|---|
| Visor System (K182967) | Cerebrotech Medical Systems, Inc. | 2018-11-23 |
| Cerebrotech CMS-5000 (K171186) | Cerebrotech Medical Systems | 2017-12-08 |
Recalls involving this device
No recalls on record reference this clearance.