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ULTRASOUND IMAGE ANALYSIS PROGRAM UltraExtend NX CUW-U001S
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- ULTRASOUND IMAGE ANALYSIS PROGRAM UltraExtend NX CUW-U001S FDA UDI
- Generic Name
- Ultrasound imaging system workstation FDA UDI
- Model / Reference
- CUW-U001S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987670104374 FDA UDI
- 510(k) Number
- K250328 FDA UDI
- FDA Product Code
- QIH FDA UDIIYN FDA UDIIYO FDA UDI
- GMDN Term
- Ultrasound imaging system workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI892.1550 FDA UDI892.1560 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ultrasound imaging system workstation
ULTRASOUND IMAGE ANALYSIS PROGRAM UltraExtend NX CUW-U001S by Canon Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Ultrasound imaging system workstation.
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- Clear Guide CORE — Clear Guide Medical · Class II
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- HOLOSCOPE — Real View Imaging , Ltd. · Class II
- Clear Guide CORE — Clear Guide Medical · Class II
- SonoSync — SAMSUNG MEDISON CO., LTD · Class II
- ULTRASOUND WORKSTATION PACKAGE — Canon Medical Systems Corporation · Class II
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
- Canon Medical Systems Corporation
Sources (1)
- FDA UDI 1d7f2339-833e-4c03-9a90-ead450d00de7 33 fields · synced May 30, 2026