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TrackX

FDA UDI

Class II (US FDA UDI)

by TRACKX TECHNOLOGY Inc.

Identity

Trade Name
TrackX FDA UDI
Generic Name
Diagnostic x-ray digital imaging system workstation application software FDA UDI
Device Name
Accessory device that mounts to the detector side of a 12 inch C-Arm FDA UDI
Model / Reference
12 inch C-Arm Collar Assembly FDA UDI
Description
Accessory device that mounts to the detector side of a 12 inch C-Arm FDA UDI

Identifiers

Catalog Number
TX-3-3142 FDA UDI
Primary DI / UDI-DI
00857088008004 FDA UDI
510(k) Number
K173736 FDA UDI
FDA Product Code
OWB FDA UDI
GMDN Term
Diagnostic x-ray digital imaging system workstation application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

TrackX by TRACKX TECHNOLOGY Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K173736 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
TRACKX TECHNOLOGY Inc.

Sources (1)

  • FDA UDI f9cf35bf-0e22-4d42-baf9-627689c93aeb 37 fields · synced May 30, 2026