Aixplorer® Ultimate

FDA UDI

Class II (US FDA UDI)

by Supersonic Imagine

Identity

Trade Name: Aixplorer® Ultimate FDA UDI
Generic Name: General-purpose ultrasound imaging system FDA UDI
Device Name: Imaging Ultrasound Diagnostic System FDA UDI
Model / Reference: SSIP940000 FDA UDI
Description: Imaging Ultrasound Diagnostic System FDA UDI

Identifiers

Catalog Number: SSIP940000 FDA UDI
Primary DI / UDI-DI: 03760193600889 FDA UDI
FDA Product Code: IYO FDA UDI
ITX FDA UDI
IYN FDA UDI
GMDN Term: General-purpose ultrasound imaging system FDA UDI

Classification

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

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 250 Centimeter FDA UDI

Category: General-purpose ultrasound imaging system

Aixplorer® Ultimate by Supersonic Imagine — 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: Supersonic Imagine

Sources (1)

FDA UDI 5683be00-b9ea-4c5c-9031-ff8c952e189d 37 fields · synced May 30, 2026