Search Results
Found 15 results
510(k) Data Aggregation
K Number
K191623Device Name
ScanX Touch/ScanX Duo Touch
Manufacturer
Air Techniques, Inc.
Date Cleared
2019-08-21
(64 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Air Techniques, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ScanX Touch/ScanX Duo Touch is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.
Device Description
The ScanX Touch is a device that scans photostimulable phosphor storage plates that have been exposed in place of X-ray film and allows the resulting images to be displayed on a personal computer monitor and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. Two models are available: The Scanx® Touch processes one imaging plate while ScanX® Duo Touch processes two at a time. The ScanX Touch also includes an RFID Phosphor Plate identification system which requires that the Phosphor Plate has an RFID tag attached to the non-imaging side of the Plate. ScanX allows multi room dental clinics to produce digital radiographs within seconds using a flexible PSP (Phosphor Storage Plates). The workflow is supported by a touch screen, for job handling (ScanManager, Patient information), preview and standalone work. ScanX produces the digital diagnostic quality intraoral image by scanning PSPs, which have been exposed to X-rays. ScanX can also work independently. If the IT network goes down, the user can still scan and save X-ray images. The images are temporarily placed in the internal memory and are later transferred to the office database. This makes the device ideally suited to provide a mobile solution when it is necessary to visit the patient outside the office. Additionally, ScanX allows computer storage, processing, retrieval and display of the processed images utilizing a user supplied software (e.g. DBSWIN) and computer. An additional feature of ScanX consists of an in-line plate eraser function that removes the latent image from the plate immediately after scanning. This design provides an efficient one-operation scanning and erasing process leaving the user with a PSP ready for the next X-ray procedure
Ask a Question
K Number
K101289Device Name
SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB
Manufacturer
AIR TECHNIQUES, INC.
Date Cleared
2010-08-03
(88 days)
Product Code
MQB, D50, MOB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
AIR TECHNIQUES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ScanX D5000 series scanners, with and without battery option are devices that read photostimulable phosphor plates that have been exposed in place of x-ray film and allow those images to be displayed on a personal computer display and stored for later recovery in a computer's memory. It will be used by physicians, dentists, veterinarians, and authorized medical auxiliary personnel for this purpose. These scanners are not intended to be used for mammographic images.
Device Description
The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.
Ask a Question
K Number
K090169Device Name
SPECTRA FLUORESCENCE CARIES DETECTION DEVICE
Manufacturer
AIR TECHNIQUES, INC.
Date Cleared
2009-08-18
(207 days)
Product Code
NBL
Regulation Number
872.1745Why did this record match?
Applicant Name (Manufacturer) :
AIR TECHNIQUES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Spectra Fluorescence Caries Detection Aid System is indicated as an aid in the detection and diagnosis of dental caries.
Device Description
The Spectra Fluorescence Caries Detection Aid System aids in the diagnosis of caries. It consists of a toothbrush-sized handpiece for examining the condition of a tooth, an umbilical cord connecting the handpiece to a computer and imaging software.
Ask a Question
K Number
K052271Device Name
RINSENDO
Manufacturer
AIR TECHNIQUES, INC.
Date Cleared
2006-05-26
(280 days)
Product Code
NYL
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
AIR TECHNIQUES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RinsEndo is used for root canal irrigation/ disinfection.
Device Description
Not Found
Ask a Question
K Number
K050693Device Name
ACCENT
Manufacturer
AIR TECHNIQUES, INC.
Date Cleared
2005-05-26
(70 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
AIR TECHNIQUES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Accent Sensor is a digital x-ray sensor system for human and non human use in dental, medical and veterinary applications. It is used to provide instant Xray images, typically of teeth, bone and surrounding tissues. Accent replaces standard X-ray film and/or phosphor plate technology.
Device Description
The X-ray tube (not part of this product) is pointed at the sensor and activated. The X-ray energy is detected by the sensor and transmitted as data to the computer to which it is connected. The software (not part of this product) interprets the image as a gray scale image and displays it on the computer monitor for diagnosis.
Ask a Question
K Number
K042397Device Name
SCANX 14
Manufacturer
AIR TECHNIQUES, INC.
Date Cleared
2004-10-05
(33 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
AIR TECHNIQUES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ScanX 14 is a device that reads photostimulable phosphor plates that have been exposed in the place of x-ray film and allow those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by physicians and authorized medical auxiliary personnel for this purpose.
Device Description
The ScanX 14 is a device that reads photostimulable phosphor plates that have been exposed in the place of x-ray film and allow those images to be displayed on a CRT and stored for later recovery in a computer memory.
Ask a Question
K Number
K042266Device Name
ACCLAIM
Manufacturer
AIR TECHNIQUES, INC.
Date Cleared
2004-08-31
(8 days)
Product Code
NRD
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
AIR TECHNIQUES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Acclaim system is primarily a tool to provide visual information to dental patients so that they can better understand the necessity and quality of the health care they receive.
Device Description
Not Found
Ask a Question
K Number
K031198Device Name
SCANX 10
Manufacturer
AIR TECHNIQUES, INC.
Date Cleared
2003-06-20
(65 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
AIR TECHNIQUES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K024285Device Name
A/T X-RAY 70
Manufacturer
AIR TECHNIQUES, INC.
Date Cleared
2003-04-16
(114 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
AIR TECHNIQUES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The A/T X-Ray 70 is an extra oral device designed to expose intra oral x-ray recording media (film, plates, sensors) for the purpose of radiographic examination and diagnosis of diseases of the teeth.
Device Description
The A/T X-Ray 70 is an extra oral device designed to expose intra oral x-ray recording media (film, plates, sensors).
Ask a Question
K Number
K013893Device Name
SCANX
Manufacturer
AIR TECHNIQUES, INC.
Date Cleared
2002-02-01
(70 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
AIR TECHNIQUES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ScanX Scanner 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 Description
The ScanX Scanner 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.
Ask a Question
Page 1 of 2