Sonio Detect (v3)
FDA 510(k) clearance K252433 · decided 2026-03-16
Clearance details
- K-number
- K252433
- Device name
- Sonio Detect (v3)
- Applicant
- Sonio
- Decision
- Substantially Equivalent
- Date received
- 2025-08-01
- Decision date
- 2026-03-16
- Days to decision
- 227 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Paris, FR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sonio
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.