Ultrasound Workstation Package

FDA UDI

Class II (US FDA UDI)

by Canon Medical Systems Corporation

Identity

Trade Name: ULTRASOUND WORKSTATION PACKAGE FDA UDI
Generic Name: Ultrasound imaging system workstation FDA UDI
Device Name: ULTRASOUND WORKSTATION PACKAGE FDA UDI
Model / Reference: TUW-U001S FDA UDI
Description: ULTRASOUND WORKSTATION PACKAGE FDA UDI

Identifiers

Primary DI / UDI-DI: 04987670100796 FDA UDI
510(k) Number: K121076 FDA UDI
FDA Product Code: IYL FDA UDI
IYN FDA UDI
LLZ FDA UDI
GMDN Term: Ultrasound imaging system workstation FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5900 FDA UDI
892.1550 FDA UDI
892.2050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Ultrasound imaging system workstation

Ultrasound Workstation Package by Canon Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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ULTRASOUND IMAGE ANALYSIS PROGRAM UltraExtend NX CUW-U001S — 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 ba61f126-a834-4d20-8580-15a717e211d7 35 fields · synced Jun 6, 2026