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Varex Digital Imaging Software, Nexus DRF, v3.6
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Varex Digital Imaging Software, Nexus DRF, v3.6 FDA UDI
- Generic Name
- X-ray system computer, diagnostic, general-purpose FDA UDI
- Model / Reference
- Nexus DRF v3.6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854344007610 FDA UDI
- 510(k) Number
- K130318 FDA UDI
- FDA Product Code
- MQB FDA UDIJAA FDA UDI
- GMDN Term
- X-ray system computer, diagnostic, general-purpose FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 FDA UDI892.1650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: X-ray system computer, diagnostic, general-purpose
Varex Digital Imaging Software, Nexus DRF, v3.6 by Varex Imaging Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as X-ray system computer, diagnostic, general-purpose.
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Cleared under the same submission
K130318 also covers:
- Nexus DRF, Digital Imaging Software — Varex Imaging Corporation
- Nexus DRF, Digital Imaging Software — Varex Imaging Corporation
- Varex Digital Imaging Software, Nexus, DRF, v2.5 — Varex Imaging Corporation
- Varex Digital Imaging System, Nexus, DRF, v3.1.0 — Varex Imaging Corporation
- Varex Digital Imaging System, Nexus, DRF, v3.2.0 — Varex Imaging Corporation
- Varex Imaging Nexus DRF Digital X-ray Imaging System — Varex Imaging Corporation
- Varex Imaging Nexus DRF Imaging Software — Varex Imaging Corporation
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Varex Imaging Corporation
Sources (2)
- FDA UDI e25be478-efcc-4e7b-b80b-2e2871f96125 33 fields · synced Jun 9, 2026
- EUDAMED 1 fields · synced May 29, 2026