FDA.reportPublic FDA data

SkyVision Ascend

Primary DI
10841736121785
Brand
SkyVision Ascend
Company
SKYTRON LLC
Model
Ascend
Catalog number
SVIS-ASCEND
Device description
4K Video Integration System
Published
2023-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841736121785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084173612178510841736121785

GMDN Terms#

Term, Definition table
TermDefinition
Video image processorA mains electricity (AC-powered) device designed to receive the electronic signals sent from a video camera for the purpose of editing and processing them into images. It may have additional features which compensate for/enhance the colour and light qualities provided. The picture images will typically be, e.g., a video recording of a magnetic resonance imaging (MRI) examination. Other forms of recording media may be used.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-759-8766info@skytron.us

Regulatory Flags#

DUNS number
078375583
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841736117085Skytron1-011-01-211-011-01-212022-01-29
10841736117092Skytron1-011-01-221-011-01-222022-01-29
10841736117108Skytron1-011-01-31-011-01-32022-01-29
10841736117115Skytron1-011-01-41-011-01-42022-01-29
10841736117122Skytron1-011-01-51-011-01-52022-01-29
10841736117283Skytron1-011-02-421-011-02-422022-01-29
10841736117313Skytron1-011-02-521-011-02-522022-01-29
10841736117351Skytron1-011-03-51-011-03-52022-01-29
10841736117375Skytron1-011-04-221-011-04-222022-01-29
10841736117382Skytron1-011-04-231-011-04-232022-01-29
10841736117412Skytron1-011-04-431-011-04-432022-01-29
10841736117429Skytron1-011-04-51-011-04-52022-01-29
10841736117443Skytron1-011-05-211-011-05-212022-01-29
10841736117450Skytron1-011-05-221-011-05-222022-01-29
10841736117498Skytron1-011-05-51-011-05-52022-01-29
10841736117603Skytron1-011-06-311-011-06-312022-01-29
10841736117658Skytron1-011-06-3B1-011-06-3B2022-01-29
10841736117726Skytron1-011-06-421-011-06-422022-01-29
10841736117801Skytron1-011-07-211-011-07-212022-01-29
10841736117825Skytron1-011-07-41-011-07-42022-01-29

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