Identity
- Trade Name
- i-CAT FLX™ imaging system FDA UDI
- Generic Name
- Cone beam computed tomography system, head/neck FDA UDI
- Device Name
- V10 FDA UDI
- Model / Reference
- 0.830.6300 FDA UDI
- Description
- V10 FDA UDI
Identifiers
- Catalog Number
- 08306300 FDA UDI
- Primary DI / UDI-DI
- D090083063000 FDA UDI
- 510(k) Number
- K162085 FDA UDI
- FDA Product Code
- OAS FDA UDI
- GMDN Term
- Cone beam computed tomography system, head/neck 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: Cone beam computed tomography system, head/neck
i-CAT FLX™ imaging system by Dental Imaging Technologies Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cone beam computed tomography system, head/neck.
- Dental CT Scanner AXR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA · Class II
- CS 8100 3D — CARESTREAM HEALTH, INC. · Class II
- ProVecta 3D Prime Ceph — Durr Dental AG · Class II
- MiniCATIQ — Xoran Technologies, LLC · Class II
- CS 8100 3D Access — CARESTREAM HEALTH, INC. · Class II
- CS 9300 — CARESTREAM HEALTH, INC. · Class II
- PREXION EVOLVE — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA · Class II
- xCAT XL — Xoran Technologies, LLC · Class II
Cleared under the same submission
K162085 also covers:
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
- Dental Imaging Technologies Corporation
Sources (1)
- FDA UDI 0344f96e-8a74-4ca7-8070-9650dc6e41d5 37 fields · synced Jun 9, 2026