DEVICE: ScanX Classic for Intraoral & Extraoral Imaging (D678F37050)
Device Identifier (DI) Information
ScanX Classic for Intraoral & Extraoral Imaging
F3705
In Commercial Distribution
AIR TECHNIQUES, INC.
F3705
In Commercial Distribution
AIR TECHNIQUES, INC.
ScanX Classic for Intraoral & Extraoral Imaging is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
No | |
No | |
Yes | |
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No |
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? |
---|---|---|---|---|
35928 | Radiography digital imaging scanner |
A laser or light-based optical unit designed to convert medical images originally captured on x-ray film or phosphor storage plate (PSP) into a digital format. Examples of this device include devices employing video frame grabbers, and scanners which use lasers or charge-coupled devices. Depending on the design, the digitized images can then be digitally transferred from location to location, archived, or used with other digital image processing, analysis or recording systems.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MUH | System,X-Ray,Extraoral Source,Digital |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K013893 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 5 and 80 Percent (%) Relative Humidity |
Storage Environment Temperature: between -29 and 33 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Height: 24.5 Inch |
Depth: 15.5 Inch |
Width: 15.5 Inch |
Weight: 51 Pound |
Device Record Status
891c31dd-55b9-4c2d-aebd-de28566db13a
August 23, 2018
4
September 23, 2016
August 23, 2018
4
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
D678F37001 | 1 | D678F37050 | In Commercial Distribution | Box | |
D678F3700U1 | 1 | D678F37050 | In Commercial Distribution | BOX | |
D678F37051 | 1 | D678F37050 | In Commercial Distribution | BOX | |
D678F3700C1 | 1 | D678F37050 | In Commercial Distribution | BOX | |
D678F3750C1 | 1 | D678F37050 | In Commercial Distribution | BOX | |
D678F37501 | 1 | D678F37050 | In Commercial Distribution | BOX |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-247-8324
xx@xx.com
xx@xx.com