Identity
- Trade Name
- OmniTom Elite FDA UDI
- Generic Name
- Limited-view-field CT system FDA UDI
- Model / Reference
- 0-NL5000-002 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10815411020663 FDA UDI
- 510(k) Number
- K202526 FDA UDI
- FDA Product Code
- JAK 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
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
Yes
FDA UDI
Category: Limited-view-field CT system
OmniTom Elite by Neurologica Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Limited-view-field CT system.
- LineUP — CurveBeam LLC · Class II
- PreXion3D Excelsior — PREXION CORPORATION · Class II
- PreXion3D Eclipse — YOSHIDA DENTAL MFG. CO., LTD., THE · Class II
- PedCAT — CurveBeam LLC · Class II
- In Reach — CurveBeam LLC · Class II
- OnSight 3D Extremity System — CARESTREAM HEALTH, INC. · Class II
- OnSight 3D Extremity System — CARESTREAM HEALTH, INC. · Class II
- HiRise — CurveBeam LLC · Class II
Cleared under the same submission
K202526 also covers:
- Arjo Huntleigh Adapter — Neurologica Corporation
- Flat Head Scan Board — Neurologica Corporation
- Hill Rom Bed Adapter — Neurologica Corporation
- Hill-Rom Advanta 2 — Neurologica Corporation
- Hill-Rom Century Adapter — Neurologica Corporation
- HillRom Centrella — Neurologica Corporation
- Huntleigh Enterprise Adapter — Neurologica Corporation
- Large Veterinary Platform — Neurologica Corporation
- MSU STRETCHER — Neurologica Corporation
- OPTION, EXTENDED SCANBOARD LONG POST WITH TARGET — Neurologica Corporation
- OPTION, EXTENDED SCANBOARD SHORT POST WITH TARGET — Neurologica Corporation
- OPTION, HILL-ROM PROGRESSA PULMONARY SCANBOARD WITH TARGET — Neurologica 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neurologica Corporation
Sources (1)
- FDA UDI 0d4b67c3-fc78-40e4-90f3-580f1cdf5237 33 fields · synced May 30, 2026