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510(k) Data Aggregation
K Number
K151414Device Name
IQQA Guide
Manufacturer
EDDA TECHNOLOGY
Date Cleared
2015-11-20
(177 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
EDDA TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IQQA-Guide System is a stereotactic accessory for Computed Tomography (CT). It displays simulated image of interventional instruments (such as biopsy needle, ablation needle, probe) on a computer monitor that also shows an imaging-based 3D model of the patient anatomy, and the current and the projected future path of the interventional instruments.
The system supports the imaging-based model derived from physician's confirmed segmentation results of patient's image scans, including intra-operative CT, pre-procedural CT, and CT or MR previously acquired before surgical procedures. Additionally, overlaying ultrasound images (when available) may be displayed with the model of patient anatomy.
The system supports a workflow based on automated image registrations of spatial mapping from one image space to another image space, or from image space to physical space. Physician may interactively adjust and confirm registration results, and evaluate 3D visualization and quantitative information in terms of distance, size, and spatial location associated with patient anatomy and instruments.
The system is intended for intra-operative guidance for surgical procedures. It is intended for use by trained physicians in clinical intervention and for structures where imaging is currently used for visualizing such procedures.
Device Description
The IQQA-Guide System is a stereotactic accessory for Computed Tomography (CT). It utilizes electromagnetic tracking technology to locate and navigate instruments relative to an imaging-based model of the patient anatomy. IOOA-Guide displays the simulated image of interventional instruments (such as biopsy needle, ablation needle, probe) on a computer monitor that also shows the imaging-based 3D model of the patient anatomy, and the current and the projected future path of the interventional instruments.
IQQA-Guide supports the imaging-based 3D model derived from physician's confirmed segmentation results of patient's image scans, including intra-operative CT, pre-procedural CT, and CT or MR previously acquired before surgical procedures. The model of segmentation results may also be loaded from saved reports of the IQOA-BodyImaging software (K141745). Additionally, overlaying ultrasound images (when available) may be displayed with the model of patient anatomy. The system supports a workflow based on automated image registrations of spatial mapping from one image space to another image space, or from image space to physical space. Physician may interactively adjust and confirm registration results, and evaluate 3D visualization and quantitative information in terms of distance, size, and spatial location associated with patient anatomy and instruments.
The IQQA-Guide system consists of an EM tracking system, software, and a computer system. The system is intended for intra-operative guidance for surgical procedures. It is intended for use by trained physicians in clinical intervention and for structures where imaging is currently used for visualizing such procedures.
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K Number
K141745Device Name
IQQA-BODYIMAGING SOFTWARE
Manufacturer
EDDA TECHNOLOGY
Date Cleared
2014-10-31
(123 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
EDDA TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IQQA-BodyImaging is a PC-based, self-contained, non-invasive image analysis software application for reviewing body imaging studies (including thoracic, abdominal and pelvic) derived from CT and MR scanners. Combining image viewing, processing and reporting tools, the software is designed to support the visualization, evaluation, and reporting of body imaging studies and physician-identified lesions. The software supports a workflow based on automated image registration for viewing and analyzing multiphase and multiple time-point volume datasets. It includes tools for interactive segmentation and labeling of organ segments and vascular/ductal/airway structures. The software provides functionalities for manual or interactive segmentation of physician-identified lesions, interactive definition of virtual resection plane and virtual needle path, and allows for regional volumetric analysis of such lesions in terms of size, position, margin, and enhancement pattern, providing information for physician's evaluation and treatment planning, monitoring, and follow-up. The software is designed for use by trained professionals, including physicians and technicians. Image source: DICOM.
Device Description
The IQQA-BodyImaging Software is a self-contained, non-invasive radiographic image analysis application that is designed to run on standard PC hardware. The image input is DICOM. The data utilized is derived from CT and MR scanners, and includes thoracic/abdominal/pelvic images. Combining image processing, viewing and reporting tools, the software supports the visualization, evaluation and reporting of body imaging scans and physician identified lesions. Viewing tools include 2D original DICOM image viewing, window level adjustment, pre-defined optimized window level setting, synchronized viewing of multi-phase datasets or volumes from multiple time-points, MPR (orthogonal, oblique and curved), MIP and MinIP, volume rendering. Analysis and evaluation tools include automatic/interactive segmentation of structures utilizing user input of seeding points and bounded boxes, interactive labeling of segmented areas, user tracing and interactive editing, quantitative measurement derived from segmentation and labeling results, and the measurement of distance between physician specified structures and landmarks. Reporting tools in the software automatically assemble information including physician identified lesion locations, measurement information, physician-input lesion characterization, lesion snapshot images across multi-phases or multiple time-points, information of organ segments and vessels/ducts/airways, and illustrative snapshots of the GUI taken by physicians, for physician's confirmation and further diagnosis and patient management note input. The IQQA-BodyImaging software supports a workflow based on automated registration for viewing and analyzing multiphase or multiple time-point volume datasets. The software automatically matches the spatial location of original DICOM images across contrasted multiphases or multiple time-points, and with physicians' interactive adjustment, to enable synchronized viewing of datasets simultaneously. Physician may also activate the temporal movie display of selected slice locations across multi-phases to aid visualization and evaluation. After identifying and marking lesions on 2D image display, physicians can either manually trace lesion boundary or activate automated tools to segment lesion. The software further includes tools for interactive segmentation and interactive labeling of organ segments and vascular/ductal/airway structures (such as liver lobes, major branches of vessels/ducts/airways), thus facilitating the visualization of spatial relationship between suspicious lesions and specified anatomical structures/landmarks. The software provides functionalities for interactive adjustment of user-defined margin size around the lesion, interactive definition of virtual resection plane, interactive definition of virtual needle path to lesion and local zone, regional analysis of lesions with respect to suze, shape, position, margin, and enhancement pattern etc, synchronized view of lesion and information between planning/baseline study and monitoring/follow-up studies, thus providing information to support physician's to evaluation of physician-identified lesions as well as treatment planning, monitoring and follow-up assessment.
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K Number
K131498Device Name
IQQA-LIVER MULTIMODALITY SOFTWARE
Manufacturer
EDDA TECHNOLOGY, INC.
Date Cleared
2013-07-25
(62 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
EDDA TECHNOLOGY, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IQQA-Liver Multimodality is a PC-based, self-contained, non-invasive image analysis software application for reviewing multiphase images derived from CT scanners and MR scanners. Combining image viewing, processing and reporting tools, the software is designed to support the visualization, evaluation and reporting of liver and physician-identified lesions.
The software supports a workflow based on automated image registration for viewing and analyzing multiphase volume datasets. It includes tools for interactive segmentation and labeling of liver segments and vascular structures. The software provides functionalities for manual or interactive segmentation of physician-identified lesions, interactive definition of virtual resection plane, and allows for regional volumetric analysis of such lesions in terms of size, position, margin and enhancement pattern, providing information for physician's evaluation and treatment planning.
The software is designed for use by trained professionals, including physicians and technicians. Image source: DICOM.
Device Description
The IQQA-Liver Multimodality Software is a self-contained, noninvasive radiographic image analysis application that is designed to run on standard PC hardware. The image data utilized is derived from sources including CT and MR scanners, and of DICOM format. Combining image processing, viewing and reporting tools, the software supports the visualization, evaluation and reporting of liver and physician identified liver lesions. Viewing tools include various standard visualization modes (e.g. original DICOM 2D image viewing, window level adjustment, svnchronized viewing of multi-phase sets, Multi-Planar Reformation (MPR) in any plane (orthogonal, oblique, curved), 3D views in rendering mode (MIP. MinIP, volume rendering), and their relationship to originally acquired images from modality). Analysis and evaluation tools include segmentation of structures utilizing user input of seeding points, user tracing and interactive editing, interactive labeling of segmented areas. quantitative measurement derived from segmentation and labeling results, and the measurement of distance between physician specified structures and landmarks. Reporting tools in the software automatically assemble information (including physician identified lesion focations, measurement information. physician-input lesion characterization. Iesion ROI images across multi-phases, information of liver lobes and vessels, and illustrative snapshots of the GUI taken by user) for physician's confirmation and for further diagnosis note input.
The IQQA-Liver Multimodality software supports a workflow based on automated registration for viewing and analyzing multi-phase volume datasets. The software automatically matches the spatial location of original DICOM images across multi-phases, and provides synchronized viewing of multi-phase dataset to aid visualization. The software further includes tools for interactive segmentation and interactive labeling of liver segments and vascular structures (such as liver lobes. vessels and ducts and major branches), thus facilitation of spatial relationship between suspicious liver lesions and specified anatomical structures/landmarks. The tools also allow for interactive segmentation of physician-identified lesions using user input of seed points and boundary editing, interactive definition of virtual resection plane, interactive ' adjustment of user specified margin size around the lesion, and regional analysis of such lesions with respect to size, shape, position, margin, enhancement pattern etc, thus providing information to support physician's assessment of lesion and treatment plans.
The software is designed for use by trained professionals, including physicians and technicians. Physicians make all final patient management decisions.
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K Number
K061696Device Name
IQQA-LIVER SOFTWARE
Manufacturer
EDDA TECHNOLOGY, INC.
Date Cleared
2006-11-13
(152 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
EDDA TECHNOLOGY, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IQQA-Liver is a PC-based, self-contained, non-invasive image analysis software application for reviewing serial multi-phase CT acquisitions of the liver. Combining image viewing, processing and reporting tools, the software is designed to support physicians in the visualization, evaluation and reporting of liver and physician-identified liver lesions.
The software supports a workflow based on automated image registration for viewing and analyzing multi-phase volume datasets. It also includes tools for interactive segmentation and labeling of liver segments and vascular structures. The software provides functionalities for manual or interactive segmentation of physician-identified lesions, and allows for regional volumetric analysis of such lesions in terms of size, shape, position and enhancement pattern, providing information for physician's assessment of lesion characterization.
The software is designed for use by trained physicians. Image source: DICOM.
Device Description
The IQQA-Liver Software is a self-contained, non-invasive radiographic image analysis application that is designed to run on standard PC hardware. The image input is DICOM. Combining image processing, viewing and reporting tools, the software supports physicians in the visualization, evaluation and reporting of liver and physician identified liver lesions. Viewing tools include 2D axial image viewing, window level adjustment, a pre-defined optimized liver window level setting, synchronized viewing of multi-phase datascts, MPR and MIP. Analysis and evaluation tools include segmentation of structures utilizing user input of seeding points, interactive labeling of segmented areas, quantitative measurement derived from segmentation and labeling results, and the measurement of distance between physician specified structures to landmarks. Reporting tools in the software automatically assemble information (including physician identified lesion locations, measurement information, physician-input lesion characterization, lesion ROl images across multi-phases, and illustrative snapshots of the GUI taken by physicians) for physician's confirmation and for further diagnosis note input. The IQQA-Liver software supports a workflow based on automated registration for viewing and analyzing multi-phase volume datasets. The software automatically matches the spatial location of axial images across multi-phases, and provides synchronized viewing of multi-phase dataset to aid visualization. The software further includes tools for interactive segmentation and interactive labeling of liver segments and vascular structures (such as liver lobes, vessels and major branches), thus facilitating the visualization of spatial relationship between suspicious liver lesions and specified anatomical structures/landmarks. The tools also allow for interactive segmentation of physician-identified lesions using user input of seed points, and regional analysis of such lesions with respect to size, shape, position and enhancement pattern, thus providing information to help physician's assessment of lesion characterization. The software is designed for use by trained physicians only. Physicians make all final patient management decisions.
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K Number
K042408Device Name
IQQA-CHEST SOFTWARE PACKAGE
Manufacturer
EDDA TECHNOLOGY, INC.
Date Cleared
2004-10-08
(35 days)
Product Code
OMJ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
EDDA TECHNOLOGY, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IQQA-Chest is a PC-Based, self-contained, non-invasive image analysis package used during the review of digital chest radiographic images. Combining image viewing, evaluation and reporting tools, the software is designed to support the physician in the identification of lung lesions (e.g. nodules), as well as the confirmation, evaluation and documentation of such physician-identified lesions. The IQQA-Chest software package supports a workflow based on automated segmentation for the visual identification of possible lesions. The tools also allow for regional analysis of possible lesions in terms of size, shape and position, thus aiding the physician in the characterization of physician-identified suspicious lesions. Image source: DICOM
Device Description
The IQQA-Chest Software Package is a self-contained, non-invasive thoracic radiographic image analysis package that is designed to run on standard PC hardware. Combining image viewing tools (e.g. image window level, pan, zoom, enhancement viewing), evaluation tools (e.g. automatic/interactive segmentation, quantitative measurements derived from marking and segmentation), and reporting tools (e.g. saved lesion, measurement information, physician-input nodule characterization, and etc), the software package is designed to support the physician in the identification of lung lesions (e.g. nodules), as well as the the physician in the laonificance or entation of such physician-identified lesions. The IQQA-Chest software package supports a workflow based on automated segmentation IQQA-Chost software package bapple lesions (nodule enhanced viewing). Based on physician's request, the tool segments locations in the lung area containing circular prysional o requeed, invites fulfiling intensity signal and circular shape constraints) that would typically correlate with lung nodules. The tools also allow for regional that would typessible lesions with respect to size, shape and position, aiding the anaryold or pobo characterization of physician-identified suspicious lesions.
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