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510(k) Data Aggregation
K Number
K041937Device Name
RESTITU
Manufacturer
RESONANT MEDICAL, INC.
Date Cleared
2004-11-16
(120 days)
Product Code
IYE, IWB, KPQ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
RESONANT MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RESTITU is intended for use in external beam Radiation Therapy (RT) / Radiosurgery (RS) to locate internal anatomy that moves relative to external or bony landmarks, so as to position that anatomy correctly for delivery of conformal radiation.
RESTITU™ can be used for the positioning of patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images.
Device Description
The RESTITU system integrates medical diagnostic ultrasound systems, position sensing optical tracking systems, graphics workstations and other parts used to link these components together.
RESONANT's RESTITU is a 3D ultrasound-based image-guidance system that utilizes an ultrasound device, an optical camera tracking device and software platform to produce high quality data needed to perform accurate patient positioning and tumor localization.
RESTITU provides the capability to acquire high quality volumetric data before or after a treatment delivery fraction providing a strong set of data for treatment plan-delivery comparison studies. The RESTITU system can be integrated in any radiotherapy planning or treatment room for treatment verification. The RESTITU system resides in both the CT-Sim and LINAC rooms and can be fully integrated into a comprehensive data and image network.
In both the radiotherapy planning and treatment rooms, the RESTITU system is used to acquire 2D U/S image slices with the integrated ultrasound system, and to match each of these 2D slices with 3D position and orientation obtained from the optical tracking component. In addition, the system also accomplishes the following tasks:
1. Enable users to segment anatomical structures from the 3D U/S volume data set;
2. Calculate the position and shape of a segmented anatomical structure;
3. Calculate the vector and magnitude of the displacement between two anatomical structures obtained from two 3D data sets acquired at different times;
4. Enable users to contour anatomical structures from the 3-D ultrasound volume set or 2-D ultrasound image slices:
5. Track position of treatment couch to verify patient position.
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