Voluson

FDA UDI

Class II (US FDA UDI)

by GE Ultrasound Korea Ltd.

Identity

Trade Name: VOLUSON FDA UDI
Generic Name: General-purpose ultrasound imaging system FDA UDI
Device Name: VOLUSON SWIFT+ CONSOLE ASSY FDA UDI
Model / Reference: SWIFT+ FDA UDI
Description: VOLUSON SWIFT+ CONSOLE ASSY FDA UDI

Identifiers

Primary DI / UDI-DI: 00195278006820 FDA UDI
510(k) Number: K201828 FDA UDI
FDA Product Code: IYN FDA UDI
ITX FDA UDI
IYO FDA UDI
GMDN Term: General-purpose ultrasound imaging system FDA UDI

Classification

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

Yes

FDA UDI

Category: General-purpose ultrasound imaging system

Voluson by GE Ultrasound Korea Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose ultrasound imaging system.

SE12-3 Gen II® — SUPERSONIC IMAGINE · Class II
SUPERSONIC MACH 40 — SUPERSONIC IMAGINE · Class II
HS50 — SAMSUNG MEDISON CO., LTD · Class II
EBit Series Diagnostic Ultrasound System — CHISON Medical Technologies Co., Ltd. · Class II
Display Module(M5, International, Alone) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
WS80A Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD · Class II
HS50 / HS60 Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD · Class II
MEDISONO — Medisono, LLC · Class II

Cleared under the same submission

K201828 also covers:

Voluson — GE Ultrasound Korea 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: GE Ultrasound Korea Ltd.

Sources (1)

FDA UDI 4851b7cd-ed39-4d85-914c-746fb0647d8b 36 fields · synced May 30, 2026