FDA.reportPublic FDA data

LODOX

Primary DI
06009880828036
Brand
LODOX
Company
LODOX SYSTEMS (PTY) LTD
Model
Xmplar-dr
Catalog number
CL-08-0012-A16
Device description
The Xmplar-dr is a full body, low dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiology cases, as well as forensic pathology cases.
Published
2023-08-31
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
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013999000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013999000LODOX, MODEL BASELINELodox Systems (Pty), Ltd.2002-08-06JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009880828036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009880828036060098808280366009880828036

GMDN Terms#

Term, Definition table
TermDefinition
Stationary basic diagnostic x-ray system, digitalAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity40 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Temperature5 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
635684694
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06009880828081LODOXeXero-drCL-08-0016-I22021-08-12
06009880828098LODOXXmplar-drCL-08-00122021-08-12
06009880828104LODOXXmplar-drCL-08-0012-A82021-08-12
06009880828111LODOXXmplar-drCL-08-0015-B12021-08-12
06009880828142LODOXeXero-drCL-08-0013-H42021-08-12
06009880828159LODOXXmplar-drCL-08-0015-B22021-08-12
06009880828166LODOXeXero-drCL-08-0013-H22021-08-12
06009880828128LodoxeXero-drCL-08-0013-H112019-05-10
06009880828135LODOXXmplar-drCL-08-0013-A112020-11-04
06009880828074LodoxeXero-drCL-08-0013-H72018-05-02
06009880828067LodoxeXero-drCL-08-0013-H62018-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-05-12
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-02-27
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-01-21
00850025268387Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-11-03
00850025268370Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-09-24
00850025268349Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-07-11
00850025268363Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-06-03
00850025268356Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-23
00850025268332Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-16
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
00850025268318Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-03-21
00850025268325Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-11-21
00850025268301Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-20
00850025268257Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-05
00850025268295Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-08-13
10884521837102ILLUMISITECovidien LPJAK2024-08-09
10884521837126ILLUMISITECovidien LPJAK2024-08-09
10884521837133ILLUMISITECovidien LPJAK2024-08-09
10884521837140ILLUMISITECovidien LPJAK2024-08-09
10884521837157ILLUMISITECovidien LPJAK2024-08-09
10884521842915ILLUMISITECovidien LPJAK2024-08-09
07640167220021CAS-One IR Consumable Set GeneralCAScination AGJAK2024-06-17
00850025268240Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-05-02
08800025300237AVIEW CACCORELINE SOFT CO.,LTD.JAK2024-04-25
00850025268233Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-04-12
00850025268226Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-01-29