Identity
- Trade Name
- LOGIQ FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- LOGIQ E10s CONSOLE FDA UDI
- Model / Reference
- E10s FDA UDI
- Description
- LOGIQ E10s CONSOLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682146531 FDA UDI
- 510(k) Number
- K200119 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO FDA UDI
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1550 FDA UDI892.1560 FDA UDI
- Commercial Distribution
- Not 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
Logiq by GE Ultrasound Korea Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- GE Ultrasound Korea Ltd.
Sources (1)
- FDA UDI a226c6aa-f6d1-40ea-8d03-a68d536f8f54 37 fields · synced Jun 1, 2026