0909fcc

FDA UDI

Class II (US FDA UDI)

by Rayence Co., Ltd.

Identity

Trade Name: 0909FCC FDA UDI
Generic Name: Indirect flat panel x-ray detector FDA UDI
Device Name: X-ray, Fluoroscopic, image-intensified system FDA UDI
Model / Reference: 0909FCC FDA UDI
Description: X-ray, Fluoroscopic, image-intensified system FDA UDI

Identifiers

Primary DI / UDI-DI: 08800018602195 FDA UDI
510(k) Number: K240371 FDA UDI
FDA Product Code: JAA FDA UDI
MQB FDA UDI
GMDN Term: Indirect flat panel x-ray detector FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1650 FDA UDI
892.1680 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

0909fcc by Rayence Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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P-75 — Konica Minolta, Inc. · Class II
PEDRA — Radisen Co., Ltd. · Class II

Cleared under the same submission

K240371 also covers:

0909FCC-HS — Rayence Co., Ltd.

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 e0f46554-bb8a-4239-bd0d-2647efc7abbe 34 fields · synced Jun 1, 2026