BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

EX-M1

DI: 04547410448214 · Model: DR-ID1200 GPU EX-M1 MDR E · FUJIFILM CORPORATION

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: EX-M1
Primary DI: 04547410448214
Version / Model: DR-ID1200 GPU EX-M1 MDR E
Company Name: FUJIFILM CORPORATION
Labeler DUNS: 713565195
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2022-10-07
Public Version: 3
Public Version Date: 2024-05-30
Public Version Status: Update
Public Device Record Key: 391348ca-a4fb-4eef-b73a-3347a753c244

Device Description

A hardware for installing software.

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: Yes
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	892.1680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61109	Diagnostic x-ray digital imaging conversion system	An assembly of medical devices designed to convert an existing analogue x-ray system to digital (i.e., retrofit) through the acquisition and processing of digital images using existing analogue x-ray system components. As a system it consists of both: 1) a filmless cassette-size digital detector (e.g., indirect flat panel detector); and 2) additional processing/viewing hardware [e.g., a central processing unit (CPU) with integrated software and a monitor]. Following acquisition the system is intended to also process, view, and/or store patient images as part of picture archiving and communication. It does not contain the controls for the direct operation of an x-ray imaging system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04547410448214	GS1

Customer Contacts

Phone: +18002728465
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K142003	000

Storage Conditions

Type: Handling Environment Temperature
Temperature Range: 15 – 30 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: 15 – 80 Percent (%) Relative Humidity
Type: Handling Environment Atmospheric Pressure
Temperature Range: 70 – 106 KiloPascal
Type: Storage Environment Temperature
Temperature Range: -30 – 50 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 10 – 90 Percent (%) Relative Humidity
Type: Storage Environment Atmospheric Pressure
Temperature Range: 70 – 106 KiloPascal