SKANMOBILE

Primary DI
08904269403522
Brand
SKANMOBILE
Company
SKANRAY TECHNOLOGIES LIMITED
Model
303-000018-3
Device description
Skanmobile is a high frequency Mobile X-Ray System for diagnostic radiography. The system houses two microprocessors,one for control / supervisory functions and another for man-machine/user interface. The technology incorporatesfeedback circuits to ensure accuracy & reproducibility of X-Ray output.
Published
2022-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IZLSystem, X-Ray, Mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212940000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212940000Skanmobile, Skanmobile-DrSkanray Technologies Limited2022-03-04IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08904269403522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904269403522089042694035228904269403522

GMDN Terms#

Term, Definition table
TermDefinition
Mobile basic diagnostic x-ray system, digitalAn assembly of devices that comprise a digital general-purpose mobile 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 and the mobile design allows it to operate on mains or battery power and to be driven or pushed by an operator to various locations within a building or facility. It is commonly used for bedside imaging and for interventional and intraoperative imaging. It consists of basic modular configurations that can be upgraded. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
863358955
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08904269415105PodSKAN HF Diagnostic X-ray System303-002665-02023-12-22
18904269450783Star 60F3-86-390-0910-972019-05-24
18904269452053Star 90F3-99-390-0140-252019-09-27
18904269451520Skyline 55 wirelessF3-87-390-0074-492019-06-05
18904269451537Skyline 55 wirelessF3-87-390-0075-462019-06-05
18904269450769Star 60F3-86-390-0906-122019-05-24
18904269452046Star 90F3-99-390-0136-372019-05-22
18904269452886STAR 65F3-86-390-1000-212019-01-21
18904269450301Spotskan F3-85-390-0335-132019-05-24
18904269450318SPOTSKANF3-85-390-0336-102019-05-24
08904269409531SKANRAD 400303-000783-42022-05-11
08904269403683SKANMOBILE DR303-000018-162022-04-21
08904269405519Skan C Mobile C - Arm X - Ray systemF303-000187-22019-01-21
08904269400460Intraskan DC Plus303-000134-262020-08-10
08904269400477Intraskan DC Plus303-000134-272020-08-10
08904269400521Rayos DC303-000134-802020-08-10
08904269400538Rayos DC303-000134-812020-08-10
08904269400545Rayos DC303-000134-822020-08-10
08904269400552Rayos DC303-000134-832020-08-10
08904269400569Imagescan HD303-001201-02020-08-10

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Primary DI, Brand, Company table
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