VISION

Basic Information

• Brand Name: VISION
• Primary DI: 08606102809118
• Version / Model: Vision U
• Company Name: VISARIS DOO
• Labeler DUNS: 565466828
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-13
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 3285ea86-f300-4fc8-9819-e31a76860e76

Device Description

Visaris Vision combines our Visaris Avanse® cleared PACS software (K150725) with all the other components required to make a complete digital diagnostic X‐ray system, including tube stands, tube heads, collimators, generators, tables, and (already cleared) digital X‐ray panels.

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
KPR	System, X-Ray, Stationary	Radiology	892.1680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37645	Stationary basic diagnostic x-ray system, digital	An assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08606102809118	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K160620	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 500 – 1060 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 KiloPascal