cV5 Diagnostic Ultrasound System

FDA UDIEUDAMED

Class II (US FDA UDI)

by Samsung Medison Co., Ltd

Identity

Trade Name: cV5 Diagnostic Ultrasound System FDA UDI
Generic Name: General-purpose ultrasound imaging system FDA UDI
Model / Reference: cV5 FDA UDI

Identifiers

Primary DI / UDI-DI: 08800289981883 FDA UDI
510(k) Number: K250999 FDA UDI
FDA Product Code: IYN FDA UDI
IYO FDA UDI
ITX FDA UDI
LLZ FDA UDI
QIH FDA UDI
GMDN Term: General-purpose ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1550 FDA UDI
892.1560 FDA UDI
892.1570 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

Yes

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

MRI Safety

MR Unsafe FDA UDI

Category: General-purpose ultrasound imaging system

cV5 Diagnostic Ultrasound System by Samsung Medison Co., Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Cleared under the same submission

K250999 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Samsung Medison Co., Ltd

Sources (2)

FDA UDI 4e50bb80-a7ed-4282-a421-e3c9cebc4948 33 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 4, 2026