Identity
- Trade Name
- ECG Module(AHA) FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Model / Reference
- USO-UA3EAD0/WR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806167712563 FDA UDI
- 510(k) Number
- K150478 FDA UDI
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDI
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1560 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
No
FDA UDI
Category: General-purpose ultrasound imaging system
ECG Module(AHA) by Samsung Medison Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K150478 also covers:
- A35 Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD
- A35 Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD
- ACCESSORY SET — SAMSUNG MEDISON CO., LTD
- ACCESSORY SET — SAMSUNG MEDISON CO., LTD
- ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM — SAMSUNG MEDISON CO., LTD
- ECG Module(AHA) — SAMSUNG MEDISON CO., LTD
- ECG Module(IEC) — SAMSUNG MEDISON CO., LTD
- ECG Module(IEC) — SAMSUNG MEDISON CO., LTD
- Transducer C2-6IC — SAMSUNG MEDISON CO., LTD
- Transducer CA1-7A — SAMSUNG MEDISON CO., LTD
- Transducer CF4-9 — SAMSUNG MEDISON CO., LTD
- Transducer CV1-8A — SAMSUNG MEDISON CO., LTD
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
- Samsung Medison Co., Ltd
Sources (1)
- FDA UDI c3bb8939-37bf-43a0-bc7e-9be5f23acadd 33 fields · synced May 30, 2026