SonoSync

FDA UDI

Class II (US FDA UDI)

by Samsung Medison Co., Ltd

Identity

Trade Name: SonoSync FDA UDI
Generic Name: Ultrasound imaging system workstation FDA UDI
Model / Reference: USO-SYCPK10/SW FDA UDI

Identifiers

Primary DI / UDI-DI: 08809944935018 FDA UDI
510(k) Number: K241302 FDA UDI
FDA Product Code: LLZ FDA UDI
IYN FDA UDI
IYO FDA UDI
GMDN Term: Ultrasound imaging system workstation FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
892.1550 FDA UDI
892.1560 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

MRI Safety

MR Unsafe FDA UDI

Category: Ultrasound imaging system workstation

SonoSync by Samsung Medison Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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HOLOSCOPE — Real View Imaging , Ltd. · 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: Samsung Medison Co., Ltd

Sources (1)

FDA UDI 5b4a2eac-86b0-4e31-b2e0-76b4d8f7454e 33 fields · synced May 31, 2026