FDA.reportPublic FDA data

TRON

Primary DI
00860008443700
Brand
TRON
Company
XORAN TECHNOLOGIES LLC
Model
11050
Device description
TRON is a mobile, open bore, fluoroscope and cone beam computed tomography system designed for high-resolution bone window and soft tissue imaging of anatomy that fits within the imaging aperture.
Published
2023-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221230000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221230000TRONXoran Technologies, LLC2022-07-28OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008443700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008443700008600084437008600084437000860008443700

GMDN Terms#

Term, Definition table
TermDefinition
Mobile general-purpose fluoroscopic x-ray system, digitalA mobile (within an imaging facility) general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. 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. Images can be both real-time and delayed formats.

Regulatory Flags#

DUNS number
079255809
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008443755MiniCATIQ+100402024-10-02
00860008443731MiniCATIQ100152024-01-29
00860290000315MiniCATIQ100092016-09-20
00860008443748MiniCAT 2D100312024-01-29
00860008443717Xoran Workstationv.52024-01-18
00860008443724MiniCAT 2D100352023-07-26
00860290000384XoranConnectv.62022-08-15
00860290000391Xoran Workstationv5.15.52021-06-16
00860290000377MiniCAT 2D100302020-12-14
00860290000360xCAT IQ110202019-06-17
00860290000353MiniCAT2020100202018-07-16
00860290000308MiniCAT100042016-09-20
00860290000322XoranConnect5.22016-09-22
00860290000339xCAT110002017-06-28
00860290000346xCAT XL110102018-04-10

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