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Sonio Detect
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref v1510(k) K230365
by Sonio
Identity
- Trade Name
- Sonio Detect EUDAMEDFDA UDI
- Generic Name
- Ultrasound imaging system application software FDA UDI
- Device Name
- Sonio Detect EUDAMEDSonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP in the following) to perform their routine fetal ultrasound examinations in real-time. Sonio Detect can be used by Healthcare Professionals HCPs during fetal ultrasound exams for Trimester 1, Trimester 2 and Trimester 3 of the fetus (GA: from 11 weeks to 37 weeks). The software is intended to assist HCPs in assuring during and after their examination that the examination is complete and all images were collected according to their protocol. FDA UDI
- Model / Reference
- v1 EUDAMED1 FDA UDI
- Description
- Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP in the following) to perform their routine fetal ultrasound examinations in real-time. Sonio Detect can be used by Healthcare Professionals HCPs during fetal ultrasound exams for Trimester 1, Trimester 2 and Trimester 3 of the fetus (GA: from 11 weeks to 37 weeks). The software is intended to assist HCPs in assuring during and after their examination that the examination is complete and all images were collected according to their protocol. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03770024341027 EUDAMEDFDA UDI
- Basic UDI-DI
- 3770024341DetectMM EUDAMED
- 510(k) Number
- K230365 FDA UDI
- FDA Product Code
- IYN FDA UDIIYO FDA UDIQIH FDA UDI
- EMDN Code
- Z12080192 PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Ultrasound imaging system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1560 FDA UDI892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- France EUDAMED
- Commercial Distribution
- Not 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 Detect 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
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 | K230365 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K240406 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 3770024341DetectMM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sonio
- EUDAMED SRN
- FR-MF-000018467
Sources (3)
- EUDAMED b15c0c5e-f051-465d-854b-b7bde3752d0f 85 fields · synced Jun 18, 2026
- FDA UDI f0cc6304-3b04-48bf-918f-6f54cde1b050 35 fields · synced May 29, 2026
- FDA 510(k) K230365 1 fields · synced May 18, 2026