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510(k) Data Aggregation
K Number
K161937Device Name
CuattroDR
Manufacturer
Date Cleared
2016-10-06
(84 days)
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Cuattro, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CuattroDR, when used with a cleared digital image capture device, provides for the capture of digital images in place of conventional film radiographic examinations.
The device is intended to be available for retrofit on existing or planned x-ray machines with a cleared digital image capture device.
The device is intended for use by trained and qualified personnel in the acquisition and review of radiographic images. The product is not intended for mammography or fluoroscopy applications.
Device Description
The CuattroDR device is a software application capable of acquiring x-ray images from commonly commercialized digital flat panels on a Windows based computer workstation. The software can use traditional mouse and keyboard inputs as well as touch screen monitors as an alternative. The use of the CuattroDR software enables the user to use a traditional x-ray generator and capture x-rav images without film. The images are processed and then presented to the user on a touch screen computer monitor, within 12 seconds after the x-ray exposure. The software also has capabilities to send images to hospital medical PACS systems and digital media for archival. In addition to this functionality, the CuattroDR software provides a user interface for generator control in the process of acquiring digital images.
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K Number
K093480Device Name
CUATTRO UNOMD
Manufacturer
Date Cleared
2010-03-05
(116 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CUATTRO, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Cuattro UnoMD, when used with a cleared digital image capture device, provides for the capture of digital images in place of conventional film radiographic examinations. The device is intended to be available for retrofit on existing or planned x-ray machines with a cleared digital image capture device. The device is intended for use by trained and qualified personnel in the acquisition and review of radiographic images. The product is not intended for mammography or fluoroscopy applications.
Device Description
The Cuattro UnoMD software is a Windows based software application capable of acquiring x-ray images from commonly commercialized digital flat panels. The software can use traditional mouse and keyboard inputs as well as touch screen monitors as an alternative. The use of the software enables the user to use a separate traditional x-ray generator and capture x-ray images without film. The images are processed and then presented to the user on a touch screen computer monitor, within 12 seconds after the x-ray exposure. The software also has capabilities to send images to hospital medical PACS systems and digital media for archival.
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