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510(k) Data Aggregation
K Number
K170793Device Name
SuRgical Planner (SRP)
Manufacturer
Surgical Theater, LLC
Date Cleared
2018-02-12
(333 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Surgical Theater, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical Theater, LLC SuRgical Planner (SRP) is intended for use as a software interface and image segmentation system for the transfer of image information from a CT, MR, or X-ray 3D Angiography (XA) medical scanner to an output file. It can also be used for pre-operative planning and surgical training in a virtual environment.
Device Description
The SuRgical Planner (SRP) is intended for use as a software interface and image segmentation system for the transfer of imaging information from a CT, MR or X-ray 3D Angiography (XA) medical scanner to an output file. It can also be used for pre-operative planning and surgical training in a virtual environment.
The SuRgical Planner is not intended to be used for diagnosis.
The SRP software has the ability of creating 3D models of the patient data from 2D scan slices. Additionally, it provides the user with the ability to input, display, color, and manipulate the 2D scan slices via a 3D representation. The software transforms 2D medical images into a dynamic interactive 3D scene with multiple point of views on a high-definition (HD) touch screen monitor. The use of a virtual reality (VR) headset provides the surgeon a 3D stereoscopic display of the same scene inside the VR headset. While wearing the VR headset, the surgeon can perform a virtual / simulated "fly-through" inside the 3D scene using controllers to perform such actions as rotate, zoom in and zoom out. The SRP with VR headset and controllers is not intended for use during surgery. The SRP is intended for use for pre-operative planning.
The SRP product does not include any custom hardware and is a software-based device that runs on a high-performance desktop PC assembled using "commercial off-the-shelf" components that meet minimum performance requirements. The design is based on an advanced, touch screen friendly, Graphical User Interface (GUI) that runs an underlying simulation engine to process medical images in DICOM format, and an image generator software engine.
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K Number
K160584Device Name
Surgical Navigation Advanced Platform (SNAP)
Manufacturer
SURGICAL THEATER, LLC
Date Cleared
2016-06-28
(119 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL THEATER, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical Theater, LLC SNAP is intended for use as a software interface and image segmentation system for the transfer of imaging information from a CT, MR or X-ray 3D Angiography (XA) medical scanner to an output file. It is also intended for use in simulating surgical treatment options both pre-operatively and intra-operatively with validated systems as identified in the device labeling.
Device Description
The Surgical Navigation Advanced Platform (SNAP) is intended for use as a software interface and image segmentation system for the transfer of imaging information from CT or MR medical scanner to an output file. It is also intended for use in simulating and evaluating surgical treatment options both pre-operatively and intra-operatively with validated systems as identified in the device labeling.
The Surgical Navigation Advanced Platform (SNAP) transforms medical images into a dynamic, interactive 3D scene, and connects to external 3rd party surgical navigation systems (i.e. "validated systems"), to extract and display intra-operative surgical navigation information (such as the 3D navigation pointer) inside the generated 3D scene. Current navigation systems usually display the navigation data on 2D black and white DICOM imagery within the external navigation system itself. The SNAP displays the same navigation data (pointer position and orientation), as it is received from the external 3rd party navigation system. in a 3D fashion inside the SNAP 3D model of the anatomy as it is reconstructed from the original DICOM slices.
The SNAP allows surgeons to analyze and plan a specific patient's case before surgery, and then take that plan into the operating room (OR) and use it in conjunction with a validated traditional navigation system during surgery. The SNAP then presents the navigation data into the advanced interactive, high quality 3D image, with multiple point of views on a high-definition (HD) touch screen monitor. The surgeon can perform a virtual / simulated "fly-through" inside the 3D scene using controls such as rotate, zoom in and zoom out. During pre-operative use a virtual reality (VR) headset further increases the surgeon's immersion level in the 3D scene by providing a 3D stereoscopic display of the same 3D scene displayed on the touch screen monitor.
The SNAP product does not include any custom hardware and is a software-based device that runs on a high performance desktop PC assembled using "commercial off-the-shelf" components. The design is based on an advanced, touch screen friendly, Graphical User Interface (GUI) that runs an underlying simulation engine to process medical images in DICOM format, and an image generator software engine.
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K Number
K140819Device Name
SURGICAL NAVIGATION ADVANCED PLATFORM
Manufacturer
SURGICAL THEATER, LLC
Date Cleared
2014-06-27
(87 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL THEATER, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical Theater, LLC SNAP is intended for use as a software interface and image segmentation system for the transfer of imaging information from a CT or MR medical scanner to an output file. It is also intended for use in simulating and evaluating surgical treatment options both pre-operatively and intra- operatively with validated systems as identified in the device labeling.
Device Description
The SNAP is software based medical image management system. It is intended for use as a software interface and image segmentation system for the transfer of imaging information from a CT or MR medical scanner to an output file. It is also intended for use in simulating and evaluating surgical treatment options both pre-operatively and intraoperatively with validated systems as identified in the device labeling. The SNAP system is based on the Surgical Theater Surgery Rehearsal Platform (SRP) image management system. The SNAP utilizes the same identical software as the SRP to create 3D models of patient data from 2D scan slices. This provides the user with ability to input, display, color, and manipulate the 2D scan slices via a 3D representation. The SNAP system enhances the SRP's capability by adding additional input and allowing the surgeon to connect to an external Image Guided System and Navigation systems (in general: "IGS"; for example Brainlab Kolibri or Brainlab Curve), and to see the incoming navigation data in the SNAP monitor. The incoming navigation data is then displayed to the surgeon inside the generated 3D model, so the surgeon gets a 3D representation of his surgery navigation session.
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K Number
K123023Device Name
SURGERY REHEARSAL PLATFORM
Manufacturer
SURGICAL THEATER, LLC
Date Cleared
2013-02-08
(133 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL THEATER, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Surgery Theater, LLC Surgery Rehearsal Platform is intended for use as a software interface and image segmentation system for the transfer of imaging information from CT or MR medical scanner to an output file. It is also intended as pre-operative software for simulating surgical treatment options.
Device Description
The Surgery Rehearsal Platform (SRP) is software based medical image management system. It is intended for use as a software interface and image segmentation system. for the transfer of imaging information from a CT or MR medical scanner, to an output file. It is also intended as pre-operative software for simulation and evaluation of surgical treatment options.
The SRP software has the capability of creating 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.
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