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510(k) Data Aggregation
K Number
K140860Device Name
ImmersiveTouch3 and MicrovisTouch
Manufacturer
Date Cleared
2014-12-16
(257 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
IMMERSIVE TOUCH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options.
Device Description
The ImmersiveTouch is software based pre-surgical planning system. It is intended for use as a software interface. It is also intended as pre-operative software for simulation and evaluation of surgical treatment options.
The ImmersiveTouch software has the capability of displaying 3D models of patient data from 2D scan slices. Additionally, it provides the user with ability to input, display, color, and manipulate the 2D scan slices via a 3D representation.
The 3D models of patient data are combined with the use of haptics. This provides the user with ability to modify the haptic properties, creating the sensation of feeling specific tissues.
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