Vivid

FDA UDI

Class II (US FDA UDI)

by GE Medical Systems (China) Co., Ltd.

Identity

Trade Name: Vivid FDA UDI
Generic Name: Cardiovascular ultrasound imaging system FDA UDI
Model / Reference: iq v204 FDA UDI

Identifiers

Primary DI / UDI-DI: 00840682146227 FDA UDI
510(k) Number: K200708 FDA UDI
FDA Product Code: ITX FDA UDI
IYO FDA UDI
IYN FDA UDI
GMDN Term: Cardiovascular ultrasound imaging system FDA UDI

Classification

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

Yes

FDA UDI

Category: Cardiovascular ultrasound imaging system

Vivid by GE Medical Systems (China) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiovascular ultrasound imaging system.

iLab™ — Boston Scientific · Class II
SLT IVUS P1 Display Unit — Provisio Medical, Inc. · Class II
iLab Ultrasound Imaging System — Boston Scientific · Class II
iLab Ultrasound Imaging System — Boston Scientific · Class II
AVVIGO™+ — Boston Scientific · Class II
Medistim System Activation Card — Medi-Stim Asa · Class II
AVVIGO™+ — Boston Scientific · Class II
Medistim MiraQ Vascular System — Medi-Stim Asa · Class II

Cleared under the same submission

K200708 also covers:

Vivid — GE Medical Systems (China) Co., 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

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Manufacturer

Manufacturer: GE Medical Systems (China) Co., Ltd.

Sources (1)

FDA UDI 39dcda55-d867-4438-9554-1c2382b4f79e 34 fields · synced May 31, 2026