Identity
- Trade Name
- Flight Dental Systems FDA UDI
- Generic Name
- Hand-held intraoral dental x-ray system, digital FDA UDI
- Device Name
- The Flight X-Vision Portable Handheld X-Ray is an ultra-safe state of the art system that has lower radiation levels than your traditional wall mounted x-rays. In addition, the ergonomic design allows the x-ray to be comfortably held in your hands and with one of the most intuitive and easy to use interfaces it makes doing a full mouth series even faster and more efficient. The X-Vision features the longest battery life on the market, with a full charge, it is able to take up to 800 shots with very low exposure times while producing the best quality images whether it’s on film, digital sensor or phosphorus plates. Finally, with the use of high quality components, from the Panasonic battery to the Toshiba tube head, made in Japan, the X-Vision is the workhorse X-Ray for every office. FDA UDI
- Model / Reference
- XR-3800 FDA UDI
- Description
- The Flight X-Vision Portable Handheld X-Ray is an ultra-safe state of the art system that has lower radiation levels than your traditional wall mounted x-rays. In addition, the ergonomic design allows the x-ray to be comfortably held in your hands and with one of the most intuitive and easy to use interfaces it makes doing a full mouth series even faster and more efficient. The X-Vision features the longest battery life on the market, with a full charge, it is able to take up to 800 shots with very low exposure times while producing the best quality images whether it’s on film, digital sensor or phosphorus plates. Finally, with the use of high quality components, from the Panasonic battery to the Toshiba tube head, made in Japan, the X-Vision is the workhorse X-Ray for every office. FDA UDI
Identifiers
- Catalog Number
- X-Vision FDA UDI
- Primary DI / UDI-DI
- D884XR3800 FDA UDI
- 510(k) Number
- K172928 FDA UDI
- FDA Product Code
- MUH FDA UDI
- GMDN Term
- Hand-held intraoral dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.1800 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
Category: Hand-held intraoral dental x-ray system, digital
Flight Dental Systems by Flight Dental Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held intraoral dental x-ray system, digital.
- Acuity DX+ — Radmedix, LLC · Class II
- EzRay Premium VET — VATECH CO., LTD. · Class II
- VistaIntra DC — VATECH CO., LTD. · Class II
- Cocoon — Dexcowin Co., Ltd. · Class II
- EzRay Air W — VATECH CO., LTD. · Class II
- XpectVision — Shenzhen Xpectvision Technology Co., Ltd. · Class II
- Eighteeth — Changzhou Sifary Medical Technology Co., Ltd. · Class II
- Smil-O-Ray — Denterprise International, Inc. · Class II
Cleared under the same submission
K172928 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
- Flight Dental Systems
Sources (1)
- FDA UDI 376d2b75-f9d4-48ae-8ada-1bb025a60d22 35 fields · synced May 30, 2026