FDA.reportPublic FDA data

QXLink

Primary DI
08809394330388
Brand
QXLink
Company
VIEWORKS CO., LTD.
Model
QXLink
Published
2024-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161113000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161113000QXLinkVieworks Co., Ltd.2016-08-05LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809394330388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809394330388088093943303888809394330388

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
688274778
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809394330807Bellalun 2DVDMS-1000S2026-07-20
08809394330906VIVIX-S 4386WFXRD-4386WA2026-07-16
08809394330241VIVIX-S 1717VFXRD-1717VA2019-05-31
08809394330289VIVIX-S 1751SFXRD-1751SB2020-03-25
08809394330258VIVIX-S 1717VFXRD-1717VB2019-05-31
08809394330357VIVIX-M 1824SFXMD-1008S2025-07-15
08809394330364VIVIX-M 2430SFXMD-2430S2025-07-15
08809394330678VIVIX-S 1751SFXRD-1751SA2025-01-23
08809394330265VIVIX-S 1012NFXRD-1012NA2024-08-01
08809394330272VIVIX-S 1012NFXRD-1012NB2024-08-01
08809394330586VIVIX-S FWFXRD-2530FAW2023-10-13
08809394330593VIVIX-S FWFXRD-3643FAW2023-10-13
08809394330609VIVIX-S FWFXRD-4343FAW2023-10-13
08809394330616VIVIX-S 4386WFXRD-4386WB2023-10-13
08809394330296VIVIX-S 2530VAWFXRD-2530VAW2020-10-06
08809394330302VIVIX-S 2530VAW PLUSFXRD-2530VAW PLUS2020-10-06
08809394330319VIVIX-S 3643VAWFXRD-3643VAW2020-10-06
08809394330326VIVIX-S 3643VAW PLUSFXRD-3643VAW PLUS2020-10-06
08809394330333VIVIX-S 4343VAWFXRD-4343VAW2020-10-06
08809394330340VIVIX-S 4343VAW PLUSFXRD-4343VAW PLUS2020-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001KF5I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L0LD0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L4120PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L7FI0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L9260PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000200F30PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000201K20PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000202L80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000203ID0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000205I00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0002066I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000207330PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0002098I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020I510PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20