TrackX 200-3TX

GUDID 00857088008134

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. The INSIGHT™-6 SNAP is designed to mount onto the shaft of a cylindrical instrument.

TRACKX TECHNOLOGY, LLC

Diagnostic x-ray digital imaging system workstation application software
Primary Device ID00857088008134
NIH Device Record Key07236060-59cb-43d2-a64c-51a6c2207bb9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrackX
Version Model NumberINSIGHT™-6 SNAP
Catalog Number200-3TX
Company DUNS080948525
Company NameTRACKX TECHNOLOGY, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-787-2259
Emailsupport@trackx.tech
Phone1-888-787-2259
Emailsupport@trackx.tech
Phone1-888-787-2259
Emailsupport@trackx.tech
Phone1-888-787-2259
Emailsupport@trackx.tech
Phone1-888-787-2259
Emailsupport@trackx.tech
Phone1-888-787-2259
Emailsupport@trackx.tech
Phone1-888-787-2259
Emailsupport@trackx.tech
Phone1-888-787-2259
Emailsupport@trackx.tech
Phone1-888-787-2259
Emailsupport@trackx.tech
Phone1-888-787-2259
Emailsupport@trackx.tech
Phone1-888-787-2259
Emailsupport@trackx.tech
Phone1-888-787-2259
Emailsupport@trackx.tech
Phone1-888-787-2259
Emailsupport@trackx.tech
Phone1-888-787-2259
Emailsupport@trackx.tech
Phone1-888-787-2259
Emailsupport@trackx.tech

Device Identifiers

Device Issuing AgencyDevice ID
GS100857088008134 [Primary]
GS100857088008141 [Package]
Package: Carton [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWBInterventional Fluoroscopic X-Ray System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-12
Device Publish Date2019-12-04

On-Brand Devices [TrackX]

00860099000899Disposable snap that snaps onto a Jamshidi for instrument tracking.
00860099000837TrackX Software
00860099000813Disposable snap that snaps onto a Jamshidi for instrument tracking. Instrument Tracker .125 I
00860099000806Optical Tracker Snap 11 0.090 IN (previously known as Snap 1)
00857088008066Disposable snap that snaps onto a Jamshidi for the purpose of instrument tracking. Component bo
00857088008035Accessory device that mounts to the source side of a 12 inch C-Arm
00857088008028Accessory device that mounts to the source side of a 9 inch C-Arm
00857088008011Accessory device that mounts to the detector side of a 9 inch C-Arm
00857088008004Accessory device that mounts to the detector side of a 12 inch C-Arm
00857088008233The device consists of a sterile Snap that includes reflective features that facilitate imaging
00857088008226The device consists of a sterile Snap that includes reflective features that facilitate imaging
00857088008202The device consists of a sterile Calibrator that includes reflective features that facilitate im
00857088008196The device consists of a sterile Screw Length Calibrator that includes reflective features that
00857088008134The device consists of a sterile Snap that includes reflective features that facilitate imaging
00857088008103The device consists of a sterile Snap that includes reflective features that facilitate imaging
00857088008097The device consists of a sterile Snap that includes reflective features that facilitate imaging
00857088008318The device consists of a sterile Calibrator that includes reflective features that facilitate im
00857088008295The device consists of a sterile Snap that includes reflective features that facilitate imaging
00857088008370The device consists of a sterile Snap that includes reflective features that facilitate imaging
00857088008363The device consists of a sterile Snap that includes reflective features that facilitate imaging
00857088008424Accessory device that mounts to a 12 Inch Collar.
00857088008417Accessory device that mounts to a 9 Inch Collar
00857088008387The device consists of a sterile Snap that includes reflective features that facilitate imaging
00857088008400The device consists of a sterile Base component that mates with an Array component to create a u
00857088008394The device consists of a sterile Base component that mates with an Array component to create a u
00857088008356The device consists of a sterile Array component that mates with an INSIGHT Base component to cr
00857088008448The device consists of a sterile Base component that mates with an Array component to create a u
00857088008431The device consists of a sterile Base component that mates with an Array component to create a u
00857088008172Accessory device that mounts to the detector side of a 9 inch C-Arm
00857088008165Accessory device that mounts to the detector side of a 12 inch C-Arm
00857088008257The device is a general surgical instrument: a sterilized, disposable, single use jamshidi like
00857088008219The device is a general surgical instrument: a non-sterile, reusable Pointer instrument.
00857088008509The device consists of a sterile Base component that mates with an Array component to create a u
00857088008493The device consists of a sterile Base component that mates with an Array component to create a u
00857088008516The device consists of a sterile Base component that mates with an Array component to create a u
00857088008530TrackX reusable adapter that enables physicians to more adequately utilize the INSIGHT BASE FLEX
00857088008547TrackX reusable adapter that enables physicians to calibrate retractors with a distal blade diam
00857088008608TrackX single-use adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L
00857088008585TrackX single-use adapter that enables physicians to more adequately utilize the INSIGHT REVOLVE
00857088008523TrackX reusable adapter that enables physicians to more adequately utilize the INSIGHT REVOLVE-B
00857088008486Accessory device that mounts to the source side of a 21cm GE OEC Elite CFD.
00857088008479Accessory device that mounts to the detector side of a 21cm GE OEC Elite CFD.
00857088008462Accessory device that mounts to the source side of a 31cm GE OEC Elite CFD.
00857088008455Accessory device that mounts to the detector side of a 31cm GE OEC Elite CFD.
00857088008561TrackX reusable adapter that enables physicians to more adequately utilize the INSIGHT REVOLVE-B
00857088008677TrackX reusable adapter that enables physicians to more adequately utilize the INSIGHT BASE FLEX
00857088008554The device is a general surgical instrument: a non-sterile, reusable Dilator instrument.
00857088008615TrackX single-use adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L
00857088008646TrackX single-use adapter base that enables physicians to more adequately utilize an INSIGHT-ARR
00857088008653TrackX single-use adapter base that enables physicians to more adequately utilize an INSIGHT-ARR

Trademark Results [TrackX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRACKX
TRACKX
87133254 5541591 Live/Registered
TrackX Technology, LLC
2016-08-10
TRACKX
TRACKX
78515085 not registered Dead/Abandoned
DataPath, Inc.
2004-11-11
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.