DEVICE: Flight Dental Systems (D884XR3800)
Device Identifier (DI) Information
Flight Dental Systems
XR-3800
In Commercial Distribution
X-Vision
Flight Dental Systems
XR-3800
In Commercial Distribution
X-Vision
Flight Dental Systems
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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44606 | Hand-held intraoral dental x-ray system, digital |
A 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.
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FDA Product Code
[?]Product Code | Product Code Name |
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MUH | System, X-Ray, Extraoral Source, Digital |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K172928 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
376d2b75-f9d4-48ae-8ada-1bb025a60d22
February 04, 2022
1
January 27, 2022
February 04, 2022
1
January 27, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined