TrackX
The device consists of a sterile Array component that mates with an INSIGHT Base component to create a unique SNAP that includes reflective features that facilitate imaging of the…
The device consists of a sterile Array component that mates with an INSIGHT Base component to create a unique 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™ ARRAY-ORANGE when assembled with an INSIGHT Base is designed to mount onto the shaft of a cylindrical instrument.
5manufacturers in China registered for this device type
86catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Trackx Technology Inc., United States |
|---|---|
| FDA product code | OWB |
| Device type | Interventional Fluoroscopic X-Ray System |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Manufacturer |
| 510(k) | K173736 |
| Record published | 2022-09-26 |
| Record revised | 2025-01-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Shelf carton of 5, carton of 5, kit carton |
| Distribution end date | 2026-04-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Pointer | In distribution | |
| INSIGHT™-6 SNAP | In distribution | |
| TrackX 1/4″ Square T-Handle | In distribution | |
| INSIGHT™ BASE-5L | In distribution | |
| INSIGHT™ BASE-3.5L | In distribution | |
| VISION™-V SNAP | In distribution | |
| Initial Dilator Snap | In distribution | |
| TrackX T-ADAPT – PEEK | In distribution | |
| 12 inch Tracking Collar Assembly; TX-3-3307 | In distribution | |
| INSIGHT™ ARRAY-GREEN | In distribution | |
| Home Base Pin Snap | In distribution | |
| Hex Pin 6mm x 150mm | In distribution | |
| TrackX Software | In distribution | |
| 9 inch Tracking Collar Assembly; TX-3-3300 | In distribution | |
| TrackX Home Base Pin – 6mm x 100mm | In distribution | |
| TrackX PE ADAPT – MJF VS | In distribution | |
| ACCESS 21-ADAPT | In distribution | |
| Dilator | In distribution | |
| TrackX Hudson MOD T-Handle | In distribution | |
| 21 cm Flat Panel Collar Assembly | In distribution | |
| TrackX NV INSERT-ADAPT | In distribution | |
| INSIGHT™ BASE FLEX-25 | In distribution | |
| Calibrator 2.0 | In distribution | |
| Hex Pin 6mm x 100mm | In distribution | |
| VISION™- A SNAP | In distribution | |
| TrackX Insight Base – NV/AT Disc Prep | In distribution | |
| Cobb Snap | In distribution | |
| TrackX Insight Base – DS Disc Prep – MJF VS | In distribution | |
| TrackX AT INSERT-ADAPT | In distribution | |
| ACCESS-CALIBRATOR CUP 1 | In distribution | |
| VISION-T SNAP | In distribution | |
| ACUITY NEEDLE – DIAMOND; 200-4TX | In distribution | |
| ACCESS-CALIBRATOR CUP 3 – MJF VS | In distribution | |
| INSIGHT™ ARRAY-AQUA | In distribution | |
| TrackX Insight Base – DS Disc Prep | In distribution | |
| INSIGHT™ ARRAY-ORANGE | In distribution | |
| TrackX AT INSERT-ADAPT 2 – MJF VS | In distribution | |
| TrackX T-ADAPT – MJF | In distribution | |
| TrackX Insight Base – NV/AT Disc Prep – MJF VS | In distribution | |
| REVOLVE BASE-NAVIGATOR | In distribution | |
| 12 inch Source Cap Original Assembly | In distribution | |
| TrackX SE RETRACT-ADAPT 5L – MJF VS | In distribution | |
| TrackX Home Base Pin – 6mm x 150mm | In distribution | |
| ACUITY NEEDLE – 15 DIAMOND – 3.2 INNER | In distribution | |
| TrackX SE RETRACT ADAPT 2-BLADE – MJF VS | In distribution | |
| T-Handle Snap | In distribution | |
| 21 cm Flat Panel Cap Assembly | In distribution | |
| TrackX NV RETRACT-ADAPT | In distribution | |
| TrackX Hudson T-Handle | In distribution | |
| TrackX HOME BASE VS SNAP | In distribution | |
| ACCESS-LR1 SNAP | In distribution | |
| INSIGHT™ ARRAY-VIOLET | In distribution | |
| 12 inch Distortion Plate Assembly; TX-3-3662 | In distribution | |
| 31 cm Flat Panel Collar Assembly | In distribution | |
| TrackX AWLSHIDI | In distribution | |
| INSIGHT™ BASE-2L | In distribution | |
| 31 cm Flat Panel Cap Assembly | In distribution | |
| 9 inch Source Cap Original Assembly | In distribution | |
| 9 Inch Distortion Plate Assembly; TX-3-3675 | In distribution | |
| TrackX PE ADAPT | In distribution | |
| INSIGHT™ BASE-6.5L | In distribution | |
| VISION™- I+ SNAP | In distribution | |
| TrackX Modular Malleting Adapter | In distribution | |
| ACCESS-CALIBRATOR CUP 2 | In distribution | |
| INSIGHT™ BASE FLEX-8 | In distribution | |
| TrackX 1/4″ EXT-ADAPT | In distribution | |
| Screw Length Calibrator | Withdrawn | |
| Snap 11 | Withdrawn | |
| TrackX NV RETRACT-ADAPT – MJF VS | Withdrawn | |
| TrackX SE RETRACT-ADAPT 6.5L – MJF VS | Withdrawn | |
| TrackX Insight Base – NV/AT Disc Prep – MJF | Withdrawn | |
| TrackX NV RETRACT-ADAPT – MJF VS | Withdrawn | |
| Calibrator | Withdrawn | |
| ATEC Lateral Kit 3.0 | Withdrawn | |
| TrackX NV RETRACT-ADAPT | Withdrawn | |
| 12 inch C-Arm Collar Assembly | Withdrawn | |
| HANG-TEN SNAP | Withdrawn | |
| NSIGHT™-6 SNAP Kit | Withdrawn | |
| 9 inch C-Arm Collar Assembly | Withdrawn | |
| ASC PROCEDURE KIT 1 | Withdrawn | |
| ATEC Lateral Kit 2.0 | Withdrawn | |
| VISION™- I SNAP | Withdrawn | |
| INSIGHT™ BASE-7L | Withdrawn | |
| INSIGHT™ BASE-6 | Withdrawn | |
| TrackX AT INSERT-ADAPT – MJF VS | Withdrawn | |
| T SNAP | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trinias | Shimadzu Corp. | 54 |
| Allura Xper FD | Philips Medical Systems Nederland B.V. | 21 |
| Azurion | Philips Medical Systems Nederland B.V. | 19 |
| LessRay | Nuvasive, Inc. | 16 |
| Intelli-C Accessory | Nrt – Nordisk Røntgen Teknik A/S | 13 |
| Pulse | Nuvasive, Inc. | 12 |
| O-ARM® | Medtronic Navigation, Inc. | 11 |
| Genoray | Genoray Co., Ltd. | 10 |
| Fujifilm Healthcare Americas Corporation | A.T.S. Applicazione Tecnologie Speciali SRL | 7 |
| Fujifilm Medical Systems U.S.A. Inc. | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
| Stephanix | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
| Amrad Medical | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
Showing 12 of 122. All products under Interventional Fluoroscopic X-Ray System
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Trackx Technology Inc. | 510(k) number | 2024-09-03 | Class III | Error in labeling | The patient label stickers may have the wrong expiration date recorded. The contract manufacturer entered the manufacturing date (2024-04-01) as the expiration date. The actual expiration date of the product is 2027-04-01. This is reflected | 82 | |
| Trackx Technology Inc. | 510(k) number | 2022-10-24 | Class II | Device Design | The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted. | 464 devices | 2026-09-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.