FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Varex Digital Imaging Software, Nexus DR, v4.15
DI: 00854344007740
·
Model: Nexus DR, v4.15
·
VAREX IMAGING CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Varex Digital Imaging Software, Nexus DR, v4.15
- Primary DI
- 00854344007740
- Version / Model
- Nexus DR, v4.15
- Company Name
- VAREX IMAGING CORPORATION
- Labeler DUNS
- 080506857
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-11
- Public Version
- 2
- Public Version Date
- 2026-03-17
- Public Version Status
- Update
- Public Device Record Key
- 5792ace7-4510-4f2a-ab6c-b61c0624c844
- Distribution End Date
- 2025-05-06
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 |
|---|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Radiology | 892.1680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40847 | X-ray system computer, diagnostic, general-purpose | A dedicated mainframe computer, personal computer (PC) or PC based platform and associated hardware, firmware, and operating system software used specifically to control and monitor the operation of a general-purpose medical x-ray system and associated image processing, display and analysis functions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854344007740 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193238 | 000 |