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510(k) Data Aggregation
K Number
K113620Device Name
MYRIAN 1.11
Manufacturer
INTRASENSE
Date Cleared
2012-07-12
(218 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
INTRASENSE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Myrian® is a software medical device aimed at reviewing images produced by all standard medical imaging devices. It also includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. Myrian® can be run from any standard client platform (such as PC) that might be purchased independently by the end user.
Common Users are trained medical professionals, including surgeons, radiologist clinicians and technicians.
This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
Device Description
Myrian® is a multi modality medical device for the review and analysis of anatomy and pathology in multi-dimensional images acquired from a variety of imaging devices. Myrian provides users with several visualization modes and includes DICOM communication, media interchange (printing, CD burning, storing).
Myrian includes toolsets which enable the reviewing physician to provide any selected relevant information for diagnosis, surgery and treatment planning to the referring physician. These toolsets are categorized as follow: Imaging tools, Manual or interactive Objects Of Interest (OOI), Reporting tools, Manual or assisted image alignment tools for multiphase or time-based image comparison, Virtual ROI Cutting Surface tool for preoperative evaluation of surgery strategies, Longitudinal Follow-up tools for oncology workflow.
Myrian® functionalities can be packaged, licensed and marketed as individual modules: XP Lung, XP Lungnodule, XP Liver, XP Vessel, XL Onco.
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K Number
K091001Device Name
MYRIAN 1.4
Manufacturer
INTRASENSE
Date Cleared
2009-06-29
(82 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
INTRASENSE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Myrian is a multi modality medical diagnostic device for the review and analysis of anatomy and pathology in multi-dimensional digital images acquired from a variety of imaging devices. It also includes DICOM communication capabilities and media interchange features (printing, CD burning, storing). It runs on any standard PC including laptops that might be purchased independently by the end user. Typical end users are trained medical professionals. Myrian includes tools which enable the reviewing physician to provide any selected relevant information for diagnosis, surgery and treatment planning to the referring physician. This device is not indicated for mammography use. Lossy compressed mammography-images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
Device Description
Myrian® with its modules is designed to run on standard PC hardware, through the installed operating system. The hardware is all "off-the-shelf" standard computer components and may be purchased independently by the end user. Myrian is a multi modality medical diagnostic device for the review and analysis of anatomy and pathology in multi-dimensional digital images acquired from a variety of imaging devices. It also includes DICOM communication capabilities and media interchange features (printing, CD burning, storing). It runs on any standard PC including laptops that might be purchased independently by the end user. Typical end users are trained medical professionals. Myrian includes tools which enable the reviewing physician to provide any selected relevant information for diagnosis, surgery and treatment planning to the referring physician. These toolsets are categorised as follow: Enhanced imaging tools such as: Multi-Planar Reformation (MPR) views in any plane (orthogonal, oblique or curved), 3D views in any rendering mode (MIP, MiniP, Average, Volume Rendering). Cross-sectional or Endoscope Exploration Modes along a centerline (e.g. of a vessel, a colon ... etc.). Filet Visualization Mode, to visualize as a flat surface any tubular hollow organ (such as a colon). Manual or interactive Objects Of Interest such as : Annotations of Interest, for information or measurement purposes. Paths (considered as Annotations of Interest). Regions of Interest, for anatomical and pathological structure isolation (such as liver, spleen, lungs, colon ... etc.) through which any measurement can be performed. Points of Interest, for marking areas such as lesions, tumors ... etc. Reporting tools : Objects of Interest generates reports which may be viewed and sent to standard film or paper printers or sent electronically to an intranet web server or any other DICOM device. Manual or assisted image alignment tools : for multiphasic or time-based image comparisons. Cutting Surface Tool based on ROI for preoperative evaluation of surgery strategies (such as for the liver). All Myrian functionalities can be packaged, licensed and marketed as individual modules. The Myrian System allows the OEM customization of both the graphical user interface and the available functionalities, while implying no impact on the system performance or system intended use.
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K Number
K071000Device Name
MYRIAN
Manufacturer
INTRASENSE
Date Cleared
2007-05-14
(35 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
INTRASENSE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Myrian is a multi modality medical diagnostic device. It is aimed at reviewing and analysing anatomy and pathology. It also includes DICOM communication capabilities and media interchange features (printing, CD burning, storing). It runs on any standard PC including laptops that might be purchased independently by the end user. It provides user a set of tools meant to create and modify volumes of interest. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.
Device Description
Myrian® system is a software suite providing the following services : Import of DICOM images from any DICOM modality, workstation or PACS Visualization of DICOM images in thin MPR, thick MPR and full 3D volume rendering Creation of VOI (Volume Of Interest) with dedicated tools Calculation of volumes, surface and of average, minimum and maximum densities of VOI Follow-up of patient examination Generation of medical reports Export of DICOM images to any format, DICOM entity or media
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