2430mca

FDA UDI

Class II (US FDA UDI)

by Rayence Co., Ltd.

Identity

Trade Name: 2430MCA FDA UDI
Generic Name: Indirect flat panel x-ray detector FDA UDI
Device Name: 2430MCA is a digital mammography X-ray detector that is based on flat-panel technology. This mammographic image detector and processing unit consists of a CsI scintillator coupled to a CMOS sensor. This device needs to be integrated with a mammographic imaging system. It can be utilized to capture and digitalize X-ray images for mammographic screening. The RAW files can be further processed as DICOM compatible image files by separate console SW, Xmaru W for a mammographic screening. 2430MCA detector is connected by wire to a viewing station via ethernet connection. FDA UDI
Model / Reference: 2430MCA FDA UDI
Description: 2430MCA is a digital mammography X-ray detector that is based on flat-panel technology. This mammographic image detector and processing unit consists of a CsI scintillator coupled to a CMOS sensor. This device needs to be integrated with a mammographic imaging system. It can be utilized to capture and digitalize X-ray images for mammographic screening. The RAW files can be further processed as DICOM compatible image files by separate console SW, Xmaru W for a mammographic screening. 2430MCA detector is connected by wire to a viewing station via ethernet connection. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800018600726 FDA UDI
510(k) Number: K202902 FDA UDI
FDA Product Code: MUE FDA UDI
LLZ FDA UDI
GMDN Term: Indirect flat panel x-ray detector FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1715 FDA UDI
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

FDA UDI

Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Indirect flat panel x-ray detector

2430mca by Rayence Co., Ltd. — 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: Rayence Co., Ltd.

Sources (1)

FDA UDI f6e989dd-7960-4c85-99d5-5bf42c7182a6 35 fields · synced Jun 1, 2026