MatriXX Evolution kalibriert

FDA UDI

Class II (US FDA UDI)

by IBA Dosimetry GmbH

Identity

Trade Name: MatriXX Evolution kalibriert FDA UDI
Generic Name: Accelerator system quality assurance device FDA UDI
Device Name: MatriXX Evolution kalibriert FDA UDI
Model / Reference: E3030012 FDA UDI
Description: MatriXX Evolution kalibriert FDA UDI

Identifiers

Primary DI / UDI-DI: EIBAE30300120 FDA UDI
510(k) Number: K072374 FDA UDI
FDA Product Code: IYE FDA UDI
GMDN Term: Accelerator system quality assurance device FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5050 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: Accelerator system quality assurance device

MatriXX Evolution kalibriert by IBA Dosimetry GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K072374 also covers:

Dolphin — IBA Dosimetry GmbH
Dolphin — IBA Dosimetry GmbH
Dolphin — IBA Dosimetry GmbH
Dolphin — IBA Dosimetry GmbH
Dolphin — IBA Dosimetry GmbH
Dolphin — IBA Dosimetry GmbH
I'mRT MatriXX — IBA Dosimetry GmbH
MatriXX Evolution Angle Sensor — IBA Dosimetry GmbH

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: IBA Dosimetry GmbH

Sources (1)

FDA UDI ced7d872-3aa7-4a55-acd3-30f0870cde68 35 fields · synced Jun 8, 2026