AmCAD-US
Basic Information
- Brand Name
- AmCAD-US
- Primary DI
- 04719875622007
- Version / Model
- 1.0
- Catalog Number
- US-0101
- Company Name
- AMCAD BIOMED CORPORATION
- Labeler DUNS
- 656738726
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-14
- Public Version
- 1
- Public Version Date
- 2026-04-22
- Public Version Status
- New
- Public Device Record Key
- 6b419b22-eaaf-4acb-9b1d-4aafdbd795c3
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40873 | Ultrasound imaging system application software | An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719875622007 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162574 | 000 |