Identity
- Trade Name
- PreXion3D Excelsior FDA UDI
- Generic Name
- Limited-view-field CT system FDA UDI
- Model / Reference
- PreXion3D Excelsior FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04589557760019 FDA UDI
- FDA Product Code
- OAS FDA UDI
- GMDN Term
- Limited-view-field CT system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 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
No
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Height — 2220 Millimeter FDA UDIDepth — 1563 Millimeter FDA UDIWidth — 1158 Millimeter FDA UDI
Category: Limited-view-field CT system
PreXion3D Excelsior by Prexion Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Limited-view-field CT system.
- CT SCANNER , NL3000 ELITE, RAIL/PLATE CONFIG — Neurologica Corporation · Class II
- CERETOM FRAZER BASE PLATE AND RAILS SYSTEM — Neurologica Corporation · Class II
- LineUP — CurveBeam LLC · Class II
- PreXion3D Eclipse — YOSHIDA DENTAL MFG. CO., LTD., THE · Class II
- PedCAT — CurveBeam LLC · Class II
- CereTom — Neurologica Corporation · Class II
- In Reach — CurveBeam LLC · Class II
- OnSight 3D Extremity System — CARESTREAM HEALTH, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prexion Corporation
Sources (1)
- FDA UDI d47251e4-1981-4386-9761-473206b5f014 35 fields · synced May 31, 2026