Flight Dental Systems

Primary DI
D178XR3800
Brand
Flight Dental Systems
Company
Flight Dental Systems USA Inc.
Model
XR-3800
Catalog number
X-Vision
Device 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.
Published
2025-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MUHSystem, X-Ray, Extraoral Source, Digital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172928000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172928000Portable X-ray SystemRolence Enterprise, Inc.2018-03-16EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D178XR3800PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held intraoral dental x-ray system, digitalA diagnostic dental x-ray system designed to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. It is designed to be easily carried from location to location by a single operator. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. The data is either from analogue imaging and digitized afterwards or by digital imaging.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119439759
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D178A12H0Flight Dental SystemsA12HA12H2025-08-29
D178A12HP1000Flight Dental SystemsA12H-100A12 Operatory Package2025-08-29
D178A6E0Flight Dental SystemsA6E2025-08-29
D178A6EP1000Flight Dental SystemsA6EP-1002025-08-29
D178A6EP10120Flight Dental SystemsA6EP-1022025-08-29
D178BI22530K1Flight Dental SystemsBI-2530K2025-08-29
D178F160Flight Dental SystemsF-1602025-08-29
D178FMS25300Flight Dental SystemsFMS-25302025-08-29
D178N6LED19020Flight Dental SystemsN6LED-19022025-08-29
D178QC164K1Flight Dental SystemsQC-164K2025-08-29
D178QC165K1Flight Dental SystemsQC-165K2025-08-29
D178QC170Flight Dental SystemsQC-170KQC-170K2025-08-29
D178CLAVE16Flight Dental SystemsClave16+Clave16+2025-07-18
D178CLAVE23Flight Dental SystemsClave23+Clave23+2025-07-18
D178CLAVE28Flight Dental SystemsClave28+Clave28+2025-07-18
D178CLAVE45Flight Dental SystemsClave45+Clave45+2025-07-18
D178CLAVE8Flight Dental SystemsClave8+Clave8+2025-07-18

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