Identity
- Trade Name
- SonicEye® Dual-Array Ultrasound System FDA UDI
- Generic Name
- Hand-held ultrasound imaging system, body-surface FDA UDI
- Device Name
- Lightweight, battery-powered ultrasound system with dual-array fingertip transducer. Transducer incorporated a high-frequency liner array and a low-frequency phased array. FDA UDI
- Model / Reference
- SDA-001 FDA UDI
- Description
- Lightweight, battery-powered ultrasound system with dual-array fingertip transducer. Transducer incorporated a high-frequency liner array and a low-frequency phased array. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850012978008 FDA UDI
- 510(k) Number
- K192253 FDA UDI
- FDA Product Code
- IYO FDA UDIITX FDA UDI
- GMDN Term
- Hand-held ultrasound imaging system, body-surface FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hand-held ultrasound imaging system, body-surface
SonicEye® Dual-Array Ultrasound System by Sonivate Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hand-held ultrasound imaging system, body-surface.
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Cleared under the same submission
K192253 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sonivate Medical, Inc.
Sources (1)
- FDA UDI 2d2c9c19-d25c-4ea3-9cc3-235dec614b8f 35 fields · synced Jun 8, 2026