FDA UDI
In Commercial Distribution
🇺🇸 United States
ULTRASOUND IMAGE ANALYSIS PROGRAM UltraExtend NX CUW-U001S
DI: 04987670104374
·
Model: CUW-U001S
·
CANON INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ULTRASOUND IMAGE ANALYSIS PROGRAM UltraExtend NX CUW-U001S
- Primary DI
- 04987670104374
- Version / Model
- CUW-U001S
- Company Name
- CANON INC.
- Labeler DUNS
- 690549662
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-02
- Public Version
- 3
- Public Version Date
- 2026-03-20
- Public Version Status
- Update
- Public Device Record Key
- 1d7f2339-833e-4c03-9a90-ead450d00de7
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | Radiology | 892.2050 | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | 892.1550 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40936 | Ultrasound imaging system workstation | A freestanding image processing workstation specifically designed to be networked with one or more diagnostic ultrasound imaging systems. It is sometimes considered to be a component to a picture archiving and communication system (PACS). An ultrasound workstation differs from the operator's console in that it does not contain the controls for the direct operation of the diagnostic imaging system. It is designed to receive and transmit data both on-line and off-line and is typically located at a site remote from the operator console. It has the capability to further process, manipulate and/or view patient images and information collected from one or more ultrasounds. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987670104374 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250328 | 000 |