FDA.reportPublic FDA data

LODOX

Primary DI
06009880828142
Brand
LODOX
Company
LODOX SYSTEMS (PTY) LTD
Model
eXero-dr
Catalog number
CL-08-0013-H4
Device description
The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases.
Published
2021-08-12
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
06009880828142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009880828142060098808281426009880828142

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 Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity40 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling 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
06009880828036LODOXXmplar-drCL-08-0012-A162023-08-31
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
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
M722CD26112CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2026-05-07
B319LSN1LSNIMAGING BIOMETRICS, LLCJAK2026-04-14
B720BX360ELUNG230Brainomix 360 e-LungBRAINOMIX LIMITEDJAK2026-03-30
08719326703824LungQ®Thirona B.V.JAK2026-02-12
10841962119457Symphony Locating Bar, Prodigy2™QfixJAK2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixJAK2025-10-23
M722C25281CA252790ClearRead CT CAC ServerRiverain Technologies, Inc.JAK2025-10-17
M722CC25281CA252790ClearRead CT CAC ConsoleRiverain Technologies, Inc.JAK2025-10-17
M722CD25281CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-10-17
10810068811275Extended Patient Introducer MountAuris Health, Inc.JAK2025-09-04
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedAuris Health, Inc.JAK2025-08-04
10810068811497Monarch™ Tower Software v4.1.1Auris Health, Inc.JAK2025-06-04
10810068811503Monarch™ Cart Software v4.1.1Auris Health, Inc.JAK2025-06-04
10884521852198superDimensionCovidien LPJAK2025-05-18
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
10810068810971Monarch Endoscopy ControllerAuris Health, Inc.JAK2025-03-05
10810068810988Monarch Platform, Bronchoscopy 4.1Auris Health, Inc.JAK2025-03-03
10810068810582Monarch™ Tower Software v4.1.0Auris Health, Inc.JAK2025-03-03
10810068810599Monarch™ Cart Software v4.1.0Auris Health, Inc.JAK2025-03-03
M722CD25030CA241430ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2025-02-12
07640167220021CAS-One IR Consumable Set GeneralCAScination AGJAK2024-06-17
17630039302051Remote ControlBracco Injeneering SAJAK2024-05-29
10810068810803Monarch Bronchscope 2.0/Monarch Platform (P2)Auris Health, Inc.JAK2024-05-05
08800025300237AVIEW CACCORELINE SOFT CO.,LTD.JAK2024-04-25
37630039301980IV PoleBracco Injeneering SAJAK2024-03-01
37630039301997Floor StandBracco Injeneering SAJAK2024-03-01
10810068810766Monarch™ Software Tower v2.2.5Auris Health, Inc.JAK2024-02-16
10810068810773Monarch™ Software Cart v2.2.5Auris Health, Inc.JAK2024-02-16