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510(k) Data Aggregation
K Number
K152151Device Name
ATAL 9
Manufacturer
ATLAIM CORPORATION
Date Cleared
2015-11-10
(99 days)
Product Code
MQB, MOB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
ATLAIM CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ATAL 9 is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications.
Device Description
The ATAL 9 is a digital radiography system, featuring an integrated flat panel digital detector (FPD). ATAL 9 is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the modified panel are the same as our previous panel with a Wi-Fi wireless feature added.
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K Number
K113812Device Name
ATAL-8
Manufacturer
ATLAIM
Date Cleared
2012-05-03
(132 days)
Product Code
MQB, MOB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
ATLAIM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ATAL 8 and ATAL 8c is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications.
Device Description
The ATAL 8 and ATAL 8C are flat-panel type digital X-ray detectors that capture radiographic images in digital format within seconds, eliminating the need for an entire X-ray film or an image plate as an image capture medium. The ATAL 8 and ATAL 8C device differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector Panel is used to capture the image in electronic form. Once the system captures a radiographic image and subsequently displays and stores an image, radiologists or physicians can adjust the image electronically to optimize the view of the desired anatomy at a workstation. The system enables a user to duplicate images without having to take additional exposures so that the user can easily transmit a duplicate to the second physician who needs the duplicate image through the network. The ATAL 8 and ATAL 8C differ only in the enclosure type. They have identical technological characteristics.
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