EchoPAC

FDA UDI

Class II (US FDA UDI)

by Ge Vingmed Ultrasound

Identity

Trade Name: EchoPAC FDA UDI
Generic Name: Ultrasound imaging system application software FDA UDI
Model / Reference: Software Only v113 FDA UDI

Identifiers

Primary DI / UDI-DI: 00840682121095 FDA UDI
510(k) Number: K131685 FDA UDI
FDA Product Code: LLZ FDA UDI
GMDN Term: Ultrasound imaging system application software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ultrasound imaging system application software

EchoPAC by Ge Vingmed Ultrasound — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 Vingmed Ultrasound

Sources (1)

FDA UDI 6ea28233-b972-492a-86ea-27b2441f0de3 34 fields · synced May 30, 2026