OnSight 3d Extremity System
The OnSight 3D Extremity System acquires three-dimensional CT images and two-dimensional X-rays of arms and legs. It uses cone beam CT, with the X-ray source and detector rotating around…
The OnSight 3D Extremity System acquires three-dimensional CT images and two-dimensional X-rays of arms and legs. It uses cone beam CT, with the X-ray source and detector rotating around the extremity while the patient remains in position.
The system images one extremity at a time. It supports weight-bearing imaging of the foot, ankle, leg and knee, as well as unloaded imaging of these areas and the hand, wrist, arm and elbow.
Listed Item
Onsight 3D Extremity SYS W Atch Console
Patients and Imaging Workflow
It is intended for adults and pediatric patients aged 12 years or older in medical practices, hospital departments and imaging facilities. The standalone system supports image acquisition, patient information management, image processing and archiving.
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Jiangsu (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| 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 |
| Neusoft Medical Systems Co., Ltd. | Shenyang | Liaoning | Manufacturer | 1 |
| Philips Health Technology (China) Co., Ltd. Shenyang Branch | Shenyang | Liaoning | Specification developer | 1 |
Record
| Listed by | Carestream Health, Inc., United States |
|---|---|
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K160723 |
| Record published | 2017-01-20 |
| Record revised | 2018-10-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OnSight 3D Extremity System | In distribution | |
| OnSight 3D Extremity System | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Visicoil | IZI Medical Products LLC | 48 |
| Visicoil MR | IZI Medical Products LLC | 41 |
| Illumisite | Covidien LP | 25 |
| Imbio LDA | Imbio, LLC | 24 |
| Edge | Covidien LP | 20 |
| Revolution | GE Hangwei Medical Systems Co., Ltd. | 20 |
| Gold Fiducial | IZI Medical Products LLC | 20 |
| superDimension | Covidien LP | 17 |
| Lodox | Lodox Systems (PTY) Ltd. | 12 |
| Revolution | GE Medical Systems, L.L.C. | 12 |
| Toshiba Scanner | Canon Inc. | 10 |
| syngo.CT Dual Energy | Siemens Healthcare Limited | 7 |
Showing 12 of 495. All products under System, X-Ray, Tomography, Computed
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173478 | 2018-01-19 |
| K160723 | 2016-08-30 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-03-19 | Class II | Software design | When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s exam. | 37 units | 2020-04-27 |
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.