Fuji Imaging Plate

FDA UDI

Class I (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name: FUJI IMAGING PLATE FDA UDI
Generic Name: Computed radiography digital imaging scanner FDA UDI
Device Name: The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, bone,blood vessel, muscle,etc. with or without contrast medium. Fuji computed radiography reads the Imaging Plate, and yields diagnostic images. FDA UDI
Model / Reference: IP ST-55BDK H 1 E FDA UDI
Description: The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, bone,blood vessel, muscle,etc. with or without contrast medium. Fuji computed radiography reads the Imaging Plate, and yields diagnostic images. FDA UDI

Identifiers

Catalog Number: 47410-05901 FDA UDI
Primary DI / UDI-DI: 04547410059014 FDA UDI
510(k) Number: K862414 FDA UDI
FDA Product Code: EAM FDA UDI
GMDN Term: Computed radiography digital imaging scanner FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.1960 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

FDA UDI

Category: Computed radiography digital imaging scanner

Fuji Imaging Plate by FUJIFILM Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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 I	Pending data

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Manufacturer

Manufacturer: FUJIFILM Corporation

Sources (1)

FDA UDI e9d06fba-8700-4377-b8fc-9b8bb95e4f88 36 fields · synced May 30, 2026