Identity
- Trade Name
- TrackX FDA UDI
- Generic Name
- Diagnostic x-ray digital imaging system workstation application software FDA UDI
- Device Name
- The device is a general surgical instrument: a sterilized, disposable, single use jamshidi like needle. FDA UDI
- Model / Reference
- ACUITY NEEDLE - 15 DIAMOND - 3.2 INNER FDA UDI
- Description
- The device is a general surgical instrument: a sterilized, disposable, single use jamshidi like needle. FDA UDI
Identifiers
- Catalog Number
- 202-4TX FDA UDI
- Primary DI / UDI-DI
- 00857088008738 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
- 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
Category: Diagnostic x-ray digital imaging system workstation application software
TrackX by TRACKX TECHNOLOGY Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Diagnostic x-ray digital imaging system workstation application software.
- MEDWS — MED.E.COM · Class II
- Konica Minolta SW Opal (Acquire), 20/20 Opal (Acquire) — KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. · Class II
- syngo.Breast Care — Siemens Healthcare · Class II
- CS OMS Imaging Software — Carestream Dental LLC · Class II
- LG — Lg Electronics · Class II
- Konica Minolta SW (Acquire) Opal, 20/20 Opal (Acquire) Vizion — KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. · Class II
- syngo.Breast Care — Siemens Healthcare · Class II
- MAMMOVISTA B.smart — Siemens Healthcare · Class II
Cleared under the same submission
K173736 also covers:
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
- TrackX — TRACKX TECHNOLOGY Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- TRACKX TECHNOLOGY Inc.
Sources (1)
- FDA UDI f0a4a947-53d5-4b39-b007-88b8d40b86df 36 fields · synced May 30, 2026