FDA.reportPublic FDA data

TrackX

Primary DI
00857088008363
Brand
TrackX
Company
TrackX Technology, LLC
Model
ACCESS-LR1 SNAP
Catalog number
800-3TX
Device description
The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.
Published
2021-04-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
LLZSystem, Image Processing, Radiological
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857088008363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857088008363008570880083638570880083630857088008363

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray digital imaging system workstation application softwareAn individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a diagnostic x-ray system workstation so that it may function according to its intended purpose, e.g., for the rendering, visualization and manipulation of medical images to support the image display needs of clinicians, diagnosticians and technicians. A basic set of applications programs and routines are included with the multi-purpose diagnostic x-ray system workstation and can be upgraded to correct programming errors or to add new system capabilities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-787-2259support@trackx.tech

Regulatory Flags#

DUNS number
080948525
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850073646007TrackXTrackX Home Base Pin - 6mm x 100mm207-4TX2025-07-24
00850073646014TrackXTrackX Home Base Pin - 6mm x 150mm208-4TX2025-07-24
00850073646144TrackXACCESS-CALIBRATOR CUP 3 - MJF VSTX-3-45342026-05-26
00857088008684TrackXTrackX Insight Base - DS Disc Prep611-3TX2026-05-11
00850073646120TrackXTrackX AT INSERT-ADAPT 2 - MJF VSTX-3-45012026-04-08
00857088008769TrackXASC PROCEDURE KIT 1980-3TX2024-03-19
00850073646106TrackXTrackX SE RETRACT ADAPT 2-BLADE - MJF VSTX-3-44692026-02-24
00857088008813TrackXTrackX NV RETRACT-ADAPT - MJF VSTX-3-42012024-07-08
00857088008844TrackXTrackX AT INSERT-ADAPTTX-3-42622025-12-08
00857088008875TrackXTrackX SE RETRACT-ADAPT 5L - MJF VS1002-3TX2025-02-07
00857088008820TrackXTrackX AT INSERT-ADAPT - MJF VSTX-3-42292024-08-15
00850073646045TrackXTrackX NV RETRACT-ADAPT1000-3TX2025-10-24
00857088008660TrackXTrackX NV INSERT-ADAPT1001-3TX2024-09-12
00850073646052TrackXHome Base Pin Snap203-3TX2025-10-24
00850073646069TrackXInitial Dilator Snap204-3TX2025-10-24
00850073646076TrackXCobb Snap205-3TX2025-10-24
00850073646083TrackXT-Handle Snap206-3TX2025-10-24
00850073646113TrackXTrackX AWLSHIDITX-4-41552025-10-15
00850073646038TrackXTrackX Modular Malleting AdapterTX-3-43692025-05-16
00857088008653TrackXTrackX Insight Base - NV/AT Disc Prep - MJF VSTX-3-40792024-03-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17540262200126Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-10-05
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00884838120433SmartCTPhilips Medical Systems Nederland B.V.LLZ2026-09-28
00190376649474CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652313CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652320CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652337CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376668307CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
BN981BN002020Bolt NavigationCircinus Medical Technology LLCOWB2026-09-25
BN981BN00202BX101Bolt NavigationCircinus Medical Technology LLCOWB2026-09-25
00680211003306PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2026-09-22
00680211003290PREFERRED MEDICAL PRODUCTS LLCPREFERRED MEDICAL PRODUCTS, LLCJAA2026-09-21
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
00850079606081MC2 Portable X-ray SystemOXOS Medical, Inc.OWB2026-09-21
00850079606098EmitterOXOS Medical, Inc.OWB2026-09-21
00850079606104CassetteOXOS Medical, Inc.OWB2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00195278951700EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08
00195278951717EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15