Dicom Box

Basic Information

• Brand Name: Dicom Box
• Primary DI: 00850677007037
• Version / Model: 1
• Company Name: HYLAND LLC
• Labeler DUNS: 079941872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 5
• Public Version Date: 2019-08-20
• Public Version Status: Update
• Public Device Record Key: 92b7293f-51e6-4c7f-bd5a-98866cb7047a

Device Description

Dicom Box Image Acquisition Unit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
LMA	Digitizer, Image, Radiological	Radiology	892.2030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35928	Radiography digital imaging scanner	A laser or light-based optical unit designed to convert medical images originally captured on x-ray film or phosphor storage plate (PSP) into a digital format. Examples of this device include devices employing video frame grabbers, and scanners which use lasers or charge-coupled devices. Depending on the design, the digitized images can then be digitally transferred from location to location, archived, or used with other digital image processing, analysis or recording systems.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850677007037	GS1

Premarket Submissions

Submission Number	Supplement Number
K954875	000