0909fcb

FDA UDI

Class II (US FDA UDI)

by Rayence Co., Ltd.

Identity

Trade Name: 0909FCB FDA UDI
Generic Name: Indirect flat panel x-ray detector FDA UDI
Device Name: The 0909FCB flat panel detector employs a CsI:Tl scintillator for X-ray-to-light converter. Column-structurized CsI:Tl scintillator have high resolution performance due to much less light blurring, and is thus available for a longer period of time. CMOS active pixel detector makes extremely low noise level and highly sensitive performance. Due to seamless one chip CMOS, there is no data missing or artifacts. The high physical and functional performance of 0909FCB gives competitive image quality. The RAW files can be further processed as DICOM compatible image files by separate console SW for a radiographic diagnosis and analysis. FDA UDI
Model / Reference: 0909FCB FDA UDI
Description: The 0909FCB flat panel detector employs a CsI:Tl scintillator for X-ray-to-light converter. Column-structurized CsI:Tl scintillator have high resolution performance due to much less light blurring, and is thus available for a longer period of time. CMOS active pixel detector makes extremely low noise level and highly sensitive performance. Due to seamless one chip CMOS, there is no data missing or artifacts. The high physical and functional performance of 0909FCB gives competitive image quality. The RAW files can be further processed as DICOM compatible image files by separate console SW for a radiographic diagnosis and analysis. FDA UDI

Identifiers

Primary DI / UDI-DI: 08800018600900 FDA UDI
510(k) Number: K212753 FDA UDI
FDA Product Code: MQB FDA UDI
JAA FDA UDI
GMDN Term: Indirect flat panel x-ray detector FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1680 FDA UDI
892.1650 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: Indirect flat panel x-ray detector

0909fcb 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 70845d50-ba3c-4f80-b457-639b3a578c73 35 fields · synced May 30, 2026