Search Results
Found 1 results
510(k) Data Aggregation
K Number
K132108Device Name
MAXIO
Manufacturer
PERFINT HEALTHCARE PVT LTD
Date Cleared
2014-05-19
(315 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
PERFINT HEALTHCARE PVT LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MAXIO™ is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments during Computed Tomography (CT) guided percutaneous procedures.
MAXIO™ permits physician verification of patient position prior to needle advancement and monitoring of respiratory levels during the procedure. Image registration and overlay tools available in MAXIO™ are intended to provide guidance to the user during planning and instrument placement.
MAXIO™ is indicated for use with rigid straight instruments such as needles and probes used in Computed Tomography (CT) guided percutaneous interventional procedures performed by physicians trained for CT procedures on organs and anatomical structures in the thorax, abdomen and pelvis.
Device Description
MAXIO™ is an image-guided, physician controlled stereotactic accessory to a Computed Tomography (CT) system, intended for the stereotactic spatial positioning and orientation of an end effector and instrument guide to assist in manual advancement of one or more instruments such as rigid straight needles and probes during CT guided percutaneous procedures on organs and anatomical structures in the thorax, abdomen and pelvis.
MAXIOTM System provides pre-operative planning assistance to the physician by creating a reconstructed 3D image model of received CT data and by visually representing the planned instrument path and position(s) of one or more instruments on the model, along with performance data provided by the instrument manufacturer or as specified by the user.
MAXIO™ permits physician verification of patient position prior to needle advancement and monitoring of respiratory for levels during the procedure. Image registration and overlay tools available in MAXIO™ are intended to provide guidance to the user during planning and instrument placement. MAXIOTM is intended to be used by physicians trained for CT procedures.
MAXIO" consists of a stereotactic device and its accessories, software loaded on a computer, and a respiratory gating system. The accessories include a patient immobilizer and skin-markers. MAXIO™ System uses single use sterile disposables viz, end effector, instrument guide and drapes.
Ask a Question
Page 1 of 1