Identity
- Trade Name
- 5D FULL PACKAGE FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Model / Reference
- USO-UW85P0K/WR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806167750299 FDA UDI
- 510(k) Number
- K153529 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
5d Full Package 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
K153529 also covers:
- 5D ADV PACKAGE — SAMSUNG MEDISON CO., LTD
- 5D HEART — SAMSUNG MEDISON CO., LTD
- 5D HEART COLOR — SAMSUNG MEDISON CO., LTD
- 5D HEART UPGRADE — SAMSUNG MEDISON CO., LTD
- 5D OB PACKAGE — SAMSUNG MEDISON CO., LTD
- 5D OB PACKAGE — SAMSUNG MEDISON CO., LTD
- ACCESSORY SET — 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
- ECG MODULEAHA — SAMSUNG MEDISON CO., LTD
- Transducer C2-6 — 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 416ffa38-c0cc-4ae0-b940-d9939572d068 33 fields · synced May 31, 2026