Identity
- Trade Name
- Sonio Suspect EUDAMEDFDA UDI
- Generic Name
- Obstetrical/gynaecological ultrasound imaging system FDA UDI
- Device Name
- Sonio Suspect EUDAMEDSonio Suspect is intended to assist interpreting physicians, during or after fetal ultrasound examinations, by automatically identifying and characterizing abnormal fetal ultrasound findings on detected views, using machine learning techniques. The device is intended for use as a concurrent reading aid on acquired images, during and/or after fetal ultrasound examinations. The device provides information on abnormal findings that may be useful in rendering potential diagnosis. Patient management decisions should not be made solely on the results of the Sonio Suspect analysis. FDA UDI
- Model / Reference
- v1 EUDAMED1 FDA UDI
- Description
- Sonio Suspect is intended to assist interpreting physicians, during or after fetal ultrasound examinations, by automatically identifying and characterizing abnormal fetal ultrasound findings on detected views, using machine learning techniques. The device is intended for use as a concurrent reading aid on acquired images, during and/or after fetal ultrasound examinations. The device provides information on abnormal findings that may be useful in rendering potential diagnosis. Patient management decisions should not be made solely on the results of the Sonio Suspect analysis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03770024341034 EUDAMEDFDA UDI
- Basic UDI-DI
- 3770024341SuspectS6 EUDAMED
- 510(k) Number
- K243614 FDA UDI
- FDA Product Code
- POK FDA UDI
- EMDN Code
- Z12080192 PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Obstetrical/gynaecological ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2060 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sonio Suspect by Sonio — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243614 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 3770024341SuspectS6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sonio
- EUDAMED SRN
- FR-MF-000018467
Sources (3)
- EUDAMED 4f327794-05e6-4e92-b8e3-677278746826 61 fields · synced Jun 18, 2026
- FDA UDI f691bb75-fbcd-4caf-a620-86206e0db065 34 fields · synced May 29, 2026
- FDA 510(k) K243614 1 fields · synced May 18, 2026