FDA.reportPublic FDA data

Skan C Mobile C - Arm X - Ray system

Primary DI
08904269405519
Brand
Skan C Mobile C - Arm X - Ray system
Company
SKANRAY TECHNOLOGIES LIMITED
Model
F303-000187-2
Device description
SKAN-C, is a mobile X-Ray C-Arm fluoroscopic device to assist in guiding medical intervention surgical procedures. The device can also be used for radiographic applications.
Published
2019-01-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OWBInterventional Fluoroscopic X-Ray System
OXOImage-Intensified Fluoroscopic X-Ray System, Mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWBInterventional Fluoroscopic X-Ray SystemRadiology2
OXOImage-Intensified Fluoroscopic X-Ray System, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170946000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170946000Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V VariantSkanray Technologies Private Limited2017-11-24OXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08904269405519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904269405519089042694055198904269405519

GMDN Terms#

Term, Definition table
TermDefinition
Portable general-purpose fluoroscopic x-ray system, digitalA portable (moveable from one location to another, and easily reassembled) general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium.

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
08904269403522SKANMOBILE303-000018-32022-04-21
08904269403683SKANMOBILE DR303-000018-162022-04-21
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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