FDXConsole

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 04547410316865

by FUJIFILM Corporation

Identity

Trade Name: Console Advance EUDAMED
FDXConsole FDA UDI
Generic Name: Computed radiography digital imaging scanner FDA UDI
Device Name: DR-ID 300CL EUDAMED
The Console Advance is a workstation intended to associate digital (for CR and/or DR) images. with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. FDA UDI
Model / Reference: 04547410316865 EUDAMED
DR-ID300CL FDA UDI
Description: The Console Advance is a workstation intended to associate digital (for CR and/or DR) images. with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. FDA UDI

Identifiers

Primary DI / UDI-DI: 04547410316865 EUDAMEDFDA UDI
Basic UDI-DI: 454741010100000000000313B EUDAMED
510(k) Number: K170451 FDA UDI
FDA Product Code: LLZ FDA UDI
EMDN Code: Z11069005 DIAGNOSTIC IMAGING WORKSTATIONS EUDAMED
GMDN Term: Computed radiography digital imaging scanner FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
Special Device Type: Software EUDAMED
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Computed radiography digital imaging scanner

FDXConsole by FUJIFILM Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Computed radiography digital imaging scanner.

CANON INC. — CANON INC. · Class II
DX-M — Agfa Corp. · Class II
Vita XE CR System — CARESTREAM HEALTH, INC. · Class II
CANON INC. — CANON INC. · Class II
Radlink CR Pro 2200 — RADLINK, INC. · Class II
GMR40 Retrofit Kit — Neurologica Corporation · Class II
CANON INC. — CANON INC. · Class II
Vita Flex CR System — CARESTREAM HEALTH, INC. · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: FUJIFILM Corporation

Sources (2)

FDA UDI 2c27da27-9876-4967-8ef0-37b5660fbd84 35 fields · synced Jun 19, 2026
EUDAMED 3d290a29-aee4-468a-87d3-b8d240c928b8 61 fields · synced Jun 19, 2026