Diagnostic Ultrasound System

FDA UDI

Class II (US FDA UDI)

by Edan Instruments, Inc.

Identity

Trade Name: Diagnostic Ultrasound System FDA UDI
Generic Name: General-purpose ultrasound imaging system FDA UDI
Model / Reference: Acclarix AX15 FDA UDI

Identifiers

Primary DI / UDI-DI: 06944413811560 FDA UDI
510(k) Number: K192791 FDA UDI
K202856 FDA UDI
FDA Product Code: IYO FDA UDI
IYN FDA UDI
ITX FDA UDI
GMDN Term: General-purpose ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 FDA UDI
892.1550 FDA UDI
892.1570 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: General-purpose ultrasound imaging system

Diagnostic Ultrasound System by Edan Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K192791 also covers:

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: Edan Instruments, Inc.

Sources (1)

FDA UDI 4154c36c-35d8-43c6-bdfb-043dfb37fadd 33 fields · synced Jun 1, 2026