FDA.report

LODOX

Primary DI
06009880828159
Brand
LODOX
Company
LODOX SYSTEMS (PTY) LTD
Model
Xmplar-dr
Catalog number
CL-08-0015-B2
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
06009880828159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06009880828159060098808281596009880828159

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
06009880828166LODOXeXero-drCL-08-0013-H22021-08-12
06009880828067LodoxeXero-drCL-08-0013-H62018-04-05
06009880828128LodoxeXero-drCL-08-0013 H112019-05-10
06009880828074LodoxeXero-drCL-08-0013 H62018-05-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00884838123748Spectral CT VeridaPhilips Medical Systems Nederland B.V.JAK2026-05-26
00884838126398Spectral CT Verida RTPhilips Medical Systems Nederland B.V.JAK2026-05-26
00884838127555Upgrade Spectral CT VeridaPhilips Medical Systems Nederland B.V.JAK2026-05-26
00884838127562Upgrade Spectral CT Verida RTPhilips Medical Systems Nederland B.V.JAK2026-05-26
00884838127876Upgrade Spectral CT 7500 SW5.4Philips Medical Systems Nederland B.V.JAK2026-05-26
00884838127883Upgrades Spectral CT 7500 RT SW5.4Philips Medical Systems Nederland B.V.JAK2026-05-26
10815411020847OmniTom Elite PCDNEUROLOGICA CORP.JAK2026-03-23
04987670104701CT SCANNERCANON INC.JAK2026-03-01
04987670106538CT SCANNERCANON INC.JAK2026-03-01
19356870000038CT:VQ4DMEDICAL LIMITEDJAK2026-01-28
00195278932341Spectral Color OverlayGE MEDICAL SYSTEMS, INC.JAK2026-01-26
00195278932358Spectral Bone MarrowGE MEDICAL SYSTEMS, INC.JAK2026-01-26
00195278932365Head Auto ViewsGE MEDICAL SYSTEMS, INC.JAK2026-01-26
04068151048056Biograph Trinion.X EP5 CT128SIEMENS MEDICAL SOLUTIONS USA, INC.JAK2026-01-09
04068151048087Biograph Trinion.X EP5 CT64SIEMENS MEDICAL SOLUTIONS USA, INC.JAK2026-01-09
00884838117921Spectral CT 7500 RTPhilips Medical Systems Nederland B.V.JAK2025-12-23
07290018016206HealthOSTNANO-X AI LTDJAK2025-12-14
01935687000038CT:VQ4DMEDICAL LIMITEDJAK2025-12-08
04056869295541SOMATOM X.citeSiemens Shanghai Medical Equipment Ltd.JAK2025-11-30
04056869295558SOMATOM X.ceedSiemens Shanghai Medical Equipment Ltd.JAK2025-11-30
04056869973500SOMATOM Pro.PulseSiemens Shanghai Medical Equipment Ltd.JAK2025-11-30
04056869290355syngo.CT CaScoringSiemens Healthcare GmbHJAK2025-11-24
00198953049174RevolutionHangwei General Electric Medical System Co., Ltd.JAK2025-10-15
00198953049631RevolutionHangwei GE Medical Systems Co., Ltd.JAK2025-09-09
00198953061329NMCT 860G E MEDICAL SYSTEMS ISRAEL LTD.JAK2025-09-09
00198953061336NMCT 850G E MEDICAL SYSTEMS ISRAEL LTD.JAK2025-09-09
00195278943934RevolutionHangwei GE Medical Systems Co., Ltd.JAK2025-08-22
06971576832033uMIShanghai United Imaging Healthcare Co., Ltd.JAK2025-08-03
B720BX360ELUNG220e-LungBRAINOMIX LIMITEDJAK2025-07-25
M722C25133CA241430ClearRead CT CAC ServerRiverain Technologies, Inc.JAK2025-06-17