AmCAD-US
AmCAD-US 1.0 is software for visualising and analysing the statistical distribution of ultrasound signals backscattered by tissue. It uses radiofrequency or envelope data supplied by a…
AmCAD-US 1.0 is software for visualising and analysing the statistical distribution of ultrasound signals backscattered by tissue. It uses radiofrequency or envelope data supplied by a compatible general-purpose ultrasound system.
The software displays conventional greyscale B-mode images alongside colour-mapped ultrasound-structure images. Users select statistical methods and image parameters, define a region of interest and quantify its backscatter characteristics. A histogram provides another view of the data distribution.
Listed Item
AmCAD-US is a software package designed to quantify and visualize the backscatter statistics contained in ultrasound image data obtained from a general purpose ultrasound system. The device provides dual mode images, including conventional B-mode ultrasound image in gray scale and color-mapped US (ultrasound structure) mode image. The US-mode provides a means for viewing and displaying the backscatter statistical values. The device uses parametric model or nonparametric statistics that best describes the distribution curve of the backscattered signals. The parameters vary by the US method (backscattered statistics) selected. The preferences include options to set the parameters mapped onto the image and US method options applied to the data. The user can also select a specific region of interest (ROI) on the image for quantification analysis. AmCAD-US has a data export function to record and save the analysis results.
Analysis Results
Analysis results can be exported and saved. The colour-mapped US-mode images must not be used alone for primary diagnostic interpretation.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (5), Beijing (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Coretronic Projection (Kunshan) Corporation | Kunshan | Jiangsu | Contract manufacturer | 3 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| GE Hangwei Medical Systems 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 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 4 |
Showing 12 of 16. All 16 manufacturers in China registered for System, Image Processing, Radiological
Record
| Listed by | Amcad Biomed Corporation, Taiwan |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K162574 |
| Record published | 2026-04-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Imagegrid Radiology Viewer System | Candelis, Inc. | 173 |
| Tims System | Foresight Imaging, LLC | 159 |
| System, Image Processing, Radiological | Biomet Microfixation | 146 |
| RamSoft | Ramsoft, Inc. | 65 |
| Joints | Medstrat | 62 |
| OrthoView | Meridian Technique Ltd | 54 |
| IPS | KLS-Martin L.P. | 48 |
| NovaPACS | Novarad Corp. | 42 |
| PointCloud Knee Instruments | Unik Orthopedics, Inc | 34 |
| DTX Studio™ Clinic | Nobel Biocare AB | 34 |
| Eaglesoft | Patterson Technology Center | 33 |
| Medtronic Navigation | Medtronic Navigation, Inc. | 26 |
Showing 12 of 1,109. All products under System, Image Processing, Radiological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180867 | 2018-12-28 |
| K180006 | 2018-08-31 |
| K162574 | 2017-05-30 |
| K170069 | 2017-04-26 |
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.