FDA.report

LODOX

Primary DI
06009880828166
Brand
LODOX
Company
LODOX SYSTEMS (PTY) LTD
Model
eXero-dr
Catalog number
CL-08-0013-H2
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
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications

CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions

SubmissionSupplement
K013999000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06009880828166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06009880828166060098808281666009880828166

GMDN Terms

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

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

Regulatory Flags

DUNS number
635684694
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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
06009880828142LODOXeXero-drCL-08-0013-H42021-08-12
06009880828159LODOXXmplar-drCL-08-0015-B22021-08-12
06009880828067LodoxeXero-drCL-08-0013-H62018-04-05
06009880828128LodoxeXero-drCL-08-0013 H112019-05-10
06009880828074LodoxeXero-drCL-08-0013 H62018-05-02

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