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510(k) Data Aggregation
K Number
K143318Device Name
DR Systems Zero Download 3D Viewer (Z3D)
Manufacturer
DR Systems, Inc
Date Cleared
2015-03-10
(111 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
DR Systems, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DR Systems Z3D is intended to provide reading physicians, and other appropriate healthcare professionals tools to aid in interpreting medical images, including:
· Displaying DICOM compliant medical image volumes, such as CT, MRI, and PET.
· Reformatting images, including creation of MPRs, MinIPs, color/monochrome 3D volume rendered images
· Manipulating displayed images via control of slice interval, obliquity, perspective, rotation, window/ level, crop, zoom, color/monochrome transformation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path.
· Creating series of DICOM images and individually captured images that can be displayed and stored in a PACS.
• Measuring coronary calcium, which is intended for non-invasive identification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms.
Device Description
DR Systems Z3D (Zero Download 3D) advanced imaging solution supports MIP (maximum intensity project), MPR (multiplanar reconstruction), 3D volume rendering, and cardiac calcium scoring. The system employs server-based rendering and browser-based viewing. Reading physicians, referring physicians, and other appropriate healthcare personnel and can employ advanced image processing and display from local or remote locations.
Viewing Modes:
Multiplanar reconstruction Two 3-D viewing modes, one showing 4 images, and one showing 6 images Cardiac calcium scoring
DR Systems Z3D is similar to the predicate device, Voxar 3D. Both are PACS system accessories that allow the user to view and manipulate 3D image data sets. DR Systems Z3D does not have an AvelP analysis tool. The principles of operation and technological characteristics of the new and predicate device are the same.
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K Number
K122888Device Name
CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM
Manufacturer
CDR SYSTEMS, INC.
Date Cleared
2013-04-30
(222 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
CDR SYSTEMS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CDR Systems Precision Patient Positioning System is indicated to assist in the proper positioning of patients for radiation therapy and radiosurgery simulation and treatment including electron, photon and proton treatments. Place a clean sheet over the device to ensure a clean device from patient to patient.
Device Description
The CDR Systems Precision Patient Positioning System consists of several options that may be purchased individually or as a complete system.
1. The CDR Systems Freedom SBRT Immobilization System is designed to provide an easy to use means to immobilize, position and reposition patients undergoing stereotactic radiation therapy. The SBRT Immobilization System is manufactured from Vinvl skinned flexible polyurethane foam and carbon fiber/epoxy components.
2. The CDR Systems Couch Overlay and Couch Extension are manufactured from carbon fiber/epoxy over a foam core providing a rigid radio-translucent platform to immobilize and position the Head, Neck and Shoulders of a patient.
3. The CDR Systems Belly Board System has a generally rectangular contour with a firm base that provides patient support and locations for softer modules that provide additional support for a patient's pelvis and head. The indexing bars ensure secure fixation of the Belly Board to the treatment couch.
4. The CDR Systems Prone Breast Patient Positioning System is generally rectangular in shape with firm base and soft cushions with a specific location for, pelvis, head and breasts. An interchangeable left or right contra-lateral breast support provides support for the breast not requiring radiation treatment. The breast opposite to the contralateral breast is intentionally unsupported and is allowed to hang providing unobstructed treatment access.
5. The CDR Systems Prone Head and Neck Immobilization System is a headboard that attaches to a base plate that locates onto a couch tabletop, onto a Couch Overlay or Couch Extension and provides adjustable positive and negative tilt for patient's head. The Prone Head and Neck Immobilization System can be used for support of a patient's head in supine or prone position.
6. The CDR Systems InstaForm Foam is designed to provide an easy to use means to stabilize, position and reposition patients undergoing radiation therapy on a treatment couch. Shortly after the foam has completed expanding inside a plastic bag it becomes rigid, resulting in a customized mold of the patient's anatomy for accurate positioning and stabilization for subsequent patient setups requiring the same initial position.
7. The CDR Systems Vacuum Cushion is constructed from vinyl coated nylon material that is filled with small polystyrene beads to immobilize the patient. Once evacuated, the Vacuum Cushion holds a rigid shape over the course of a specific patients radiation therapy treatment.
8. The CDR Systems Indexing Bar is designed for the indexing of patient immobilization devices onto a treatment couchtop.
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