Identity
- Trade Name
- Varex Digital Imaging Software, Nexus DR, v4.16 FDA UDI
- Generic Name
- X-ray system computer, diagnostic, general-purpose FDA UDI
- Model / Reference
- Nexus DR, v4.16 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854344007757 FDA UDI
- 510(k) Number
- K193238 FDA UDI
- FDA Product Code
- MQB 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 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
No
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 DR, v4.16 by Varex Imaging Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K193238 also covers:
- Varex Digital Imaging Software, Nexus DR, v4.10 — Varex Imaging Corporation
- Varex Digital Imaging Software, Nexus DR, v4.12 — Varex Imaging Corporation
- Varex Digital Imaging Software, Nexus DR, v4.13 — Varex Imaging Corporation
- Varex Digital Imaging Software, Nexus DR, v4.13 — Varex Imaging Corporation
- Varex Digital Imaging Software, Nexus DR, v4.15 — Varex Imaging Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Varex Imaging Corporation
Sources (1)
- FDA UDI e0941a26-8b6e-4f23-93fb-484e2eeb1120 33 fields · synced Jun 9, 2026