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Found 5 results
510(k) Data Aggregation
K Number
K231668Device Name
Spine CAMP (1.1)
Manufacturer
Medical Metrics, Inc.
Date Cleared
2023-07-07
(30 days)
Product Code
QIH, OIH
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Medical Metrics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Spine CAMP™ is a fully-automated software that analyzes X-ray images of the spine to produce reports that contain static and/or motion metrics. Spine CAMP™ can be used to obtain metrics from sagittal plane radiographs of the lumbar and/or cervical spine and it can be used to visualize intervertebral motion via an image registration method referred to as "stabilization." The radiographic metrics can be used to characterize and assess spinal health in accordance with established quidance. For example, common clinical uses include assessing spinal stability, alignment, degeneration, fusion, motion preservation, and implant performance. The metrics produced by Spine CAMP are intended to be used to support qualified and licensed professional healthcare practitioners in clinical decision making for skeletally mature patients of age 18 and above.
Device Description
Spine CAMP™ is a fully-automated image processing software device. It is designed to be used with X-ray images and is intended to aid medical professionals in the measurement and assessment of spinal parameters. Spine CAMP™ is capable of calculating distances, angles, linear displacements, angular displacements, and mathematical combinations of these metrics to characterize the morphology, alignment, and motion of the spine. These analysis results are presented in the form of reports, annotated images, and visualizations of intervertebral motion to support their interpretation.
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K Number
K221632Device Name
Spine CAMP
Manufacturer
Medical Metrics, Inc.
Date Cleared
2022-10-18
(134 days)
Product Code
QIH
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Medical Metrics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Spine CAMP™ is a fully-automated software that analyzes X-ray images of the spine to produce reports that contain static and/or motion metrics. Spine CAMP™ can be used to obtain metrics from sagittal plane radiographs of the lumbar and/or cervical spine and it can be used to visualize intervertebral motion via an image registration method referred to as "stabilization". The radiographic metrics can be used to characterize and assess spinal health in accordance with established guidance. For example, common clinical uses include assessing spinal stability, alignment, degeneration, fusion, motion preservation, and implant performance. The metrics produced by Spine CAMP™ are intended to be used to support qualified and licensed professional healthcare practitioners in clinical decision-making for skeletally mature patients of age 18 and above.
Device Description
Spine CAMP™ is a fully-automated image processing software device. It is designed to be used with X-ray images and is intended to aid medical professionals in the measurement and assessment of spinal parameters. Spine CAMP™ is capable of calculating distances, angles, linear displacements, angular displacements, and mathematical combinations of these metrics to characterize the morphology, alignment, and motion of the spine. These analysis results are presented in the form of reports, annotated images, and visualizations of intervertebral motion to support their interpretation.
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K Number
K022585Device Name
KIMAX QMA
Manufacturer
MEDICAL METRICS, INC.
Date Cleared
2002-10-11
(67 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL METRICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KIMAX QMA™ is a quantitative imaging software application. It is designed for physicians and clinical professions who are interested in the analysis of motion in medical images, particularly in musculoskeletal images. KIMAX QMA™ permits users to review static and dynamic digital images acquired from a variety of radiographic to review static and dynamic argultative assessment of motion in radiographic .
Information obout the matiative assessment of motion in radiographic ...
Information obout th Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a 'motion analysis' report containing graphics, charts and text.
Device Description
KIMAX QMA™ is a quantitative imaging software application.
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K Number
K013098Device Name
KIMAX REMOTE VIEWING STATION
Manufacturer
MEDICAL METRICS, INC.
Date Cleared
2001-12-07
(81 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL METRICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KIMAX ™ Remote Viewing Station software and hardware (RVS) are intended to allow physicians to view static or dynamic digital images from radiographic and other medical imaging equipment. The RVS includes a high-performance computer, data storage devices, a high-resolution monitor and software to: 1) accept AVI images or import other image formats; 2) allow physician to quickly locate and display images; 3) adjust contrast and brightness, apply filters to enhance the images, zoom in on selected features of interest, pan to selected areas, and annotate images; 4) print out selected images; and 5) create reports that include text and annotated images. The RVS is intended to be used in the clinical workspace of a practicing physician.
Device Description
The KIMAX ™ Remote Viewing Station software and hardware (RVS) includes a high-performance computer, data storage devices, a high-resolution monitor and software.
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K Number
K010187Device Name
KIMAX, MODEL 1024
Manufacturer
MEDICAL METRICS, INC.
Date Cleared
2001-02-14
(23 days)
Product Code
JAA
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL METRICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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