DR 14s C DX-D IMAGING PACKAGE

Basic Information

• Brand Name: DR 14s C DX-D IMAGING PACKAGE
• Primary DI: 05414904222201
• Version / Model: 5400/523
• Catalog Number: XBOOK
• Company Name: AGFA
• Labeler DUNS: 374444883
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-23
• Public Version: 5
• Public Version Date: 2019-06-14
• Public Version Status: Update
• Public Device Record Key: 4a317ef5-d0f2-4a8d-8ea4-9c1b828a81cf

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
60265	Flat panel x-ray detector integration unit	A portable, electrically-powered device intended to enable a direct flat panel detector (not included) to be integrated as part of an analogue x-ray [i.e., screen-film, computerized radiography (plate)] system to convert the analogue x-ray system into a digital x-ray system (retrofit) using the same modality components. It is typically an electronic box which is integrated into the analogue x-ray system via wired connections to each of the components (i.e., generator, exposure button, workstation and detector), whereby it synchronizes the original analogue generator with the direct flat panel detector.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05414904222201	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K161368	000

Device Sizes

Type	Value	Unit	Text
Width	35	Centimeter
Length	43	Centimeter