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Found 6 results
510(k) Data Aggregation
K Number
K201503Device Name
Edge Air(1417) Digital Flat Panel X-ray Detector
Manufacturer
Osko, Inc.
Date Cleared
2020-06-29
(24 days)
Product Code
MQB, THI
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Osko, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Edge Air(1417) Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general purpose diagnostic procedures. Not to be used for mammography.
Device Description
Edge 40(1417) is a wired/wireless digital solid state X-ray detector that is based on flat-panel technology. The wireless LAN (IEEE 802.11a/g/w/ac) communication signals images captured to the system and improves the user operability through high-speed processing. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis The RAW files can be further processed as DICOM compatible image files by a separate console SW program (K190866 / Xmaruview V1 (Xmaru Chiroview, Xmaru Podview) / Rayence Co., Ltd.) for a diagnostic analysis.
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K Number
K172681Device Name
Edge Air Digital Flat Panel X-ray Detector
Manufacturer
OSKO, INC.
Date Cleared
2017-10-06
(30 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
OSKO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Edge Air Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general purpose diagnostic procedures. Not to be used for mammography.
Device Description
Edge Air is a wired/wireless digital solid state X-ray detector that is based on flat-panel technology. The wireless LAN (IEEE 802.11a/g/n/ac) communication signals images captured to the system and improves the user operability through high-speed processing. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize Xray images for radiographic diagnosis The RAW files can be further processed as DICOM compatible image files by a separate console SW program (K160579 / Xmaru View V1 and Xmaru PACS/ Rayence Co., Ltd.) for a diagnostic analysis.
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K Number
K172682Device Name
Edge Digital Flat Panel X-ray Detector
Manufacturer
Osko, Inc.
Date Cleared
2017-10-06
(30 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Osko, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Edge is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general purpose diagnostic procedures. Not to be used for mammography.
Device Description
Edge digital flat panel X-ray detector is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis.
The RAW files can be further processed as DICOM compatible image files by separate console SW (K160579 / XmaruView V1 and XmaruPACS/ Rayence Co.,Ltd.) for a radiographic diagnosis and analysis.
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K Number
K163048Device Name
Smart Stitching Software System, Image Processing, Radiological
Manufacturer
OSKO, INC.
Date Cleared
2017-07-28
(269 days)
Product Code
LLZ, MQB
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
OSKO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Smart Stitching software is indicated for use to allow post-capture positioning and joining of individual images to produce an additional composite image for two dimensional image review.
Device Description
Smart Stitching provides a function to read multiple medical images at one time by stitching them to one image based on overlapping areas. It supports DICOM 3.0 which is standard of medical image format as well as Tiff and Raw images. It provides additional functions such as image retrieval, storage, and transmission. Smart Stitching is designed to facilitate diagnosis by easily stitching multiple medical images, up to 5 images, from multiple captures to one image. Smart Stitching software does not serve as acquisition software nor has control function for acquisition setting.
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K Number
K150663Device Name
Diagnostic X-ray System
Manufacturer
OSKO, INC.
Date Cleared
2015-05-07
(52 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
OSKO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The XR5 diagnostic X-ray system is intended for use on adult and pediatric patients for taking diagnostics radiographic exposure of all body parts and operated by a qualified/trained doctor or technician. The XR5 diagnostic X-ray system is designed to be used with conventional film/screen, CR cassettes or digital detectors. NOT intended for Mammography use.
Device Description
The XR5 diagnostic X-ray system is used for image capture by using X-rays on a patient's body. The XR5 is a conventional X-ray machine, with an intuitive operation console to provide the user an easy way to manage optimal conditions for quality images. The high frequency generator is capable of delivering the exposition dose appropriate for general X-ray and diagnostic images of a patient. This system is made to use other detector options including: conventional films, CR, or Digital Flat Panel Detectors. Please note that the quality of the image in any detector depends on the manufacture of the receptor device. The XR5 diagnostic X-ray system doesn't provide an AEC feature.
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K Number
K150506Device Name
ELIAN Digital Diagnostic X-ray System
Manufacturer
OSKO, INC.
Date Cleared
2015-04-08
(41 days)
Product Code
KPR, MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
OSKO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ELIAN diagnostic X-ray system is intended for use on adult and pediatric patients radiographic exposure of all body parts and operated by a qualified/trained doctor or technician. NOT intended for Mammography use.
Device Description
The ELIAN is a digital radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment. The ELIAN system includes a Detector Panel, Soft Ware, Case, Grid, Power Box, Switch Box, Interconnecting Cables, U-arm Mechanical and Generator. The Detector Panel is an indirect conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Si layer with CSI. The Power Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Flugel SW transfers signals between the Detector and X-ray Generator and also indicates the status of the panel using console. Finally, the Flugel SW contains for image data capture and correction of defects on the image data.
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