FDA UDI
In Commercial Distribution
🇺🇸 United States
Varex Digital Imaging Software, Nexus DR
DI: 00854344007658
·
Model: v4.9
·
VAREX IMAGING CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Varex Digital Imaging Software, Nexus DR
- Primary DI
- 00854344007658
- Version / Model
- v4.9
- Company Name
- VAREX IMAGING CORPORATION
- Labeler DUNS
- 080506857
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-06
- Public Version
- 1
- Public Version Date
- 2021-08-16
- Public Version Status
- New
- Public Device Record Key
- 09ee00ee-b952-442d-81d9-f34f70b4d0da
Device Description
Digital image acquisition system designed to automate patient work flow that includes image processing algorithms for imaging.
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
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | Radiology | 892.1650 | 2 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Radiology | 892.1680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40868 | Angiographic x-ray system application software | An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to an x-ray fluoroscopy based imaging system including x-ray angiography system configurations. 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 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 | 00854344007658 | GS1 |
Customer Contacts
- Phone
- 801-978-5399
- [email protected]