Identity
- Trade Name
- ECG FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Model / Reference
- USO-US7EID0/WR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806167753894 FDA UDI
- 510(k) Number
- K152962 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 by Samsung Medison Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose ultrasound imaging system.
- SE12-3 Gen II® — SUPERSONIC IMAGINE · Class II
- SUPERSONIC MACH 40 — SUPERSONIC IMAGINE · Class II
- EBit Series Diagnostic Ultrasound System — CHISON Medical Technologies Co., Ltd. · Class II
- Display Module(M5, International, Alone) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- MEDISONO — Medisono, LLC · Class II
- Movement Sensor Holder Package — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- Eagus TEX20 Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- Consona N7 Super Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
Cleared under the same submission
K152962 also covers:
- CA1-7A — SAMSUNG MEDISON CO., LTD
- ECG — SAMSUNG MEDISON CO., LTD
- ECG — SAMSUNG MEDISON CO., LTD
- ECG — SAMSUNG MEDISON CO., LTD
- GEL WARMER — SAMSUNG MEDISON CO., LTD
- GELWARMER — SAMSUNG MEDISON CO., LTD
- HS70A Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD
- HS70A Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD
- HS70A Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD
- L3-12A — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Samsung Medison Co., Ltd
Sources (1)
- FDA UDI 260e7a4d-7198-4b53-8831-fad934ba61aa 33 fields · synced May 30, 2026