Who is the manufacturer of HICAT Air?

Hicat GmbH filed the 510(k) submission for HICAT Air (K152661).

What is the FDA product code for HICAT Air?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for HICAT Air?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HICAT Air?

SICAT Function (K133320); Dolphin Imaging 11.5 (K110430).

Who can help prepare an FDA 510(k) submission like HICAT Air?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HICAT Air

K152661 · Hicat GmbH · LLZ · Nov 16, 2015 · Radiology

Device Facts

Record ID	K152661
Device Name	HICAT Air
Applicant	Hicat GmbH
Product Code	LLZ · Radiology
Decision Date	Nov 16, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

HICAT Air is a software application for: - Aiding diagnosis in the ear-nose-throat region - Aiding treatment planning in the ear-nose-throat region - Aiding comparisons of different treatment options - Aiding treatment planning for oral appliances

Device Story

HICAT Air is a software application for visualization and segmentation of medical imaging data (CT, CBCT) and optical impressions. Used by medical professionals in clinical settings to aid diagnosis and treatment planning in the ENT region. Inputs include DICOM radiological data and STL/proprietary optical surface data. The software performs 3D rendering, airway segmentation, and geometric analysis. Outputs include visualized anatomical structures and planning data, which can be exported to CAD/Rapid Prototyping systems for manufacturing therapeutic devices like oral appliances. It assists clinicians in evaluating and comparing treatment options, potentially improving treatment planning accuracy and patient outcomes.

Clinical Evidence

Bench testing only. Verification and validation activities included design reviews, unit/code/integration/system tests, and usability testing. Bench testing specifically verified airway segmentation performance and geometric dimension calculation accuracy.

Technological Characteristics

Pure software device. Operates on Windows 7/8/8.1 PCs. Uses C# and C++ programming languages. Implements ray-casting algorithms for 3D volume rendering and Watershed (graph-cut) algorithms for segmentation. Connectivity via Ethernet. Complies with DICOM (NEMA PS 3.1-3.20), ISO 14971, IEC 62304, and IEC 62366 standards.

Indications for Use

Indicated for use by qualified medical professionals for diagnosis, treatment planning, and comparison of treatment options in the ear-nose-throat (ENT) region, including planning for oral appliances.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

SICAT Function (K133320)
Dolphin Imaging 11.5 (K110430)

Related Devices

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K160666 — Dentiq3D · 3D Industrial Imaging Co., Ltd. · Oct 5, 2016
K133320 — SICAT FUNCTION · Sicat GmbH & Co. KG · Feb 25, 2014
K151837 — CS 3D Imaging · Trophy · Aug 19, 2015
K222069 — Ez3D-i/E3 · Ewoosoft Co., Ltd. · Sep 6, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 16, 2015 HICAT GmbH % Mr. Frederik Kunze Head of Quality Management and Regulatory Affairs Brunnenallee 6 Bonn, North Rhine - Westphalia 53177 GERMANY Re: K152661 Trade/Device Name: HICAT Air Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 22, 2015 Received: September 23, 2015 Dear Mr. Kunze: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Michael O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. | |------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | 510(k) Number (if known) | | | K152661 | | | Device Name | | Device Proprietary Name: HICAT Air Indications for Use (Describe) HICAT Air is a software application for: - · Aiding diagnosis in the ear-nose-throat region - Aiding treatment planning in the ear-nose-throat region - · Aiding comparisons of different treatment options - · Aiding treatment planning for oral appliances Type of Use (Select one or both, as applicable) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | FORM FDA 3881 (8/14) | | |----------------------|--| |----------------------|--| {3}------------------------------------------------ # 510(k) Summary for HICAT Air #### Content and format as required by section 21 CFR 807.92 ( http://www.fda.gov/ MedicalDevices/ DeviceRegulationandGuidance/ HowtoMarket YourDevice/PremarketSubmissions/PremarketNotification510k/ucm142651.htm\ #### 1. SUBMITTER/510(K) HOLDER HICAT GmbH Brunnenallee 6 53177 Bonn Germany | Establishment Registration Number: | HICAT GmbH is not registered yet | |---------------------------------------|----------------------------------| | Telephone: | +49 (228) 854697-38 | | Facsimile: | +49 (228) 854697-99 | | Primary Contact: | Mr. Frederik Kunze | | Secondary Contact: | Dr. Manfred Breuer | | Date Prepared: | September 14th, 2015 | #### 2. DEVICE NAME AND DEVICE CLASSIFICATION | Proprietary Name: | HICAT Air | |-------------------------|-----------------------------------------------------------------------------| | Common/Usual Name: | Radiological Visualization Software for Diagnosis and Treatment Planning | | Classification Name: | System, Image Processing, Radiological | | Regulation Description: | Picture archiving and communications system | | Product Code: | LLZ | | Regulation Number: | 21 CFR 892.2050 | | Classification Class: | Class II Product | #### 3. PREDICATE DEVICES - . Primary Predicate: SICAT Function (K133320) - Reference predicate: Dolphin Imaging 11.5 (K110430) . ## 4. DEVICE DESCRIPTION HICAT Air is a pure software device. HICAT Air is a software application for the visualization and segmentation of imaging information of the ear-nose-throat (ENT) region. {4}------------------------------------------------ The imaging data originates from medical scanners such as CT or Cone Beam – CT (CBCT) scanners. This information can be complemented by the imaging information from optical impression systems. The additional information about the exact geometry of the tooth surfaces can be visualized together with the radiological data. HICAT Air is also used as a software system to aid qualified medical professionals with the diagnosis, and followed by the evaluation, comparison and planning of ENT treatment options. The medical professionals' input information and planning data may be exported from HICAT Air to be used as input data for CAD or Rapid Prototyping Systems for the manufacturing of therapeutic devices such as oral devices. ## 5. Indications for Use HICAT Air is a software application for: - Aiding diagnosis in the ear-nose-throat region - Aiding treatment planning in the ear-nose-throat region - Aiding comparisons of different treatment options - Aiding treatment planning for oral appliances ## 6. Device Comparison Table The following table shows a summary of the indications for use, technological characteristics, design and function of HICAT Air and the predicate devices. | HICAT Air Proposed | Reference predicate Dolphin Imaging 11.5 (K110430) | Primary predicate SICAT Function (K133320) | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common / Usual Name | | | | Radiological Visualization Software for Diagnosis and Treatment Planning | Not available | Radiological Visualization Software for Diagnosis and Dental Treatment Planning | | Device Description | | | | HICAT Air is a pure software device. HICAT Air is a software application for the visualization and segmentation of imaging information of the ear-nose- throat (ENT) region. The imaging data originates from medical scanners such as CT or Cone Beam – CT (CBCT) scanners. | Dolphin Imaging is a pure software device. Dolphin Imaging is a software application for the visualization of imaging information of the oral- maxillofacial region. The imaging data originates from medical scanners such as CT or DVT scanners. | SICAT Function is a pure software device. SICAT Function is a software application for the visualization and segmentation of imaging information of the oral- maxillofacial region. The imaging data originates from medical scanners such as CT or Cone Beam - CT scanners. | | This information can be complemented by the imaging information from optical impression systems. The additional information about the exact geometry of | Dolphin Imaging software is designed for capturing, storing and presenting patient images and assisting in treatment planning and case | This information can be complemented by the imaging information from optical impression systems and jaw tracking devices. The additional information about | {5}------------------------------------------------ | HICAT Air Proposed | Reference predicate Dolphin Imaging 11.5 (K110430) | Primary predicate SICAT Function (K133320) | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | the tooth surfaces can be visualized together with the radiological data. HICAT Air is also used as a software system to aid qualified medical professionals with the diagnosis, and followed by the evaluation, comparison and planning of ENT treatment options. The medical professionals' input information and planning data may be exported from HICAT Air to be used as input data for CAD or Rapid Prototyping Systems for the manufacturing of therapeutic devices such as oral devices. | diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed practitioners. Acquisition of 2D image data can be performed from multiple types of devices, including digital radiography devices such as x-ray machines, generic imaging devices that support the TWAIN interface standard, such as flatbed scanners and standard image file formats (Jpeg, Bitmap, etc.) stored on a computer, camera memory card or similar. The following features are available: Import from a variety of 3D dataset formats (DICOM) High-quality, fast 3D rendering Three-dimensional airway segmentation and analysis in the ear-nose throat- region Airway analysis: Analyze the airway by drawing a border around your selected portion of the volumetric scan; the program will automatically fill in and display all the airway space within that border, then report back telling you the volume of airway space in cubic millimeters. It will also locate, display and measure, in square millimeters, the most constricted spot of that airway. Cross sections in Multiple | the exact geometry of the tooth surfaces and the mandibular movement can be visualized together with the radiological data. SICAT Function is also used as a software system to aid qualified dental professionals with the evaluation and planning of dental treatment options. The dental professionals' treatment planning information may be exported from SICAT Function to be used as input data for CAD or Rapid Prototyping Systems for the manufacturing of therapeutic devices such as oral appliances. | {6}------------------------------------------------ | | HICAT Air Proposed | Reference predicate Dolphin Imaging 11.5 (K110430) | Primary predicate SICAT Function (K133320) | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Planar View (MPV) Precise volume orientation | | | | | Volume stitching: Combine two separate volumes into one 2D facial photo wrap onto volume | | | | | Volume-to-volume superimposition | | | | | 3D nerve marking | | | | | TMJ analysis | | | | | Generate cephalometric and panoramic radiographs | | | | | 3D-2D measurements: distance, angle and area | | | | | Create animated movies with automated scripts | | | | | Design image layouts and reports | | | | | Images export to other applications | | | | | 3D implant treatment planning and simulation | | | | | Distinguish biological structures via their radiolucency with a Hounsfield Unit measuring tool | | | Indications for Use | | | | | Indications for Use | HICAT Air is a software application for: • Aiding diagnosis in the ear-nose-throat region. • Aiding treatment planning in the ear- nose-throat region. • Aiding comparisons of different treatment options. • Aiding treatment planning for oral appliances | Intended Use Statement of 510(k) Summary K110430: "Dolphin Imaging software is designed for use by specialized dental practices for capturing, storing and presenting patient images and assisting in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are | Indications for Use Statement of 510(k) Summary K133320: SICAT Function is a software application for the visualization and segmentation of imaging information of the oral- maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. It is also used as a software system to | | | | dependent on the interpretation of trained | aid qualified dental professionals with the | {7}------------------------------------------------ | | HICAT Air Proposed | Reference predicate Dolphin Imaging 11.5 (K110430) | Primary predicate SICAT Function (K133320) | |--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | and licensed practitioners." Product information from Appendix B-2 indicates among others: Aiding diagnosis in the ENT-region Aiding treatment planning in the ENT-region Aiding comparisons of different treatment options | evaluation of dental treatment options. The dental professionals' planning data may be exported from SICAT Function and used as input data for CAD or Rapid Prototyping Systems. | | Contraindications | none | unknown | none | | | Medical Data Viewing | | | | Data types visualized | 3D volume data, optical impressions | 3D volume data, 2D radiological x-ray data, images and photographs | 3D volume data, optical impressions, jaw motion tracking data | | Imaging data visualization region | ENT region including the oral-maxillofacial region | ENT region including the oral-maxillofacial region | oral-maxillofacial region | | | Viewing Modes | | | | Orthogonal slices | Axial, coronal, sagittal Features and algorithms are identical to SICAT Function. | Axial, coronal, sagittal | Axial, coronal, sagittal | | Special Dental View: Panoramic View | Panoramic view (ray sum) based on a panoramic curve. Panoramic curve can be manually adjusted. (available in the optical impression registration window) Features and Algorithms are identical to SICAT Function. | Yes | Panoramic view (ray sum) based on a panoramic curve. Panoramic curve can be manually adjusted. | | Special dental view: Cephalometric View | No | Yes | No | | Special dental views: TSA and LSA | Transversal slice (TSA) and longitudinal slice (LSA), both with respect to panoramic curve. (available in the optical impression registration window) Features and Algorithms identical to SICAT Function | Single transversal slices are generated. | Transversal slice (TSA) and longitudinal slice (LSA), both with respect to panoramic curve. | | 3D volume rendering | Yes, volume rendering using a standard and well established ray-casting algorithm with integration along rays, and volume rendering utilizing standard | Yes | Yes | {8}------------------------------------------------ | | HICAT Air Proposed | Reference predicate Dolphin Imaging 11.5 (K110430) | Primary predicate SICAT Function (K133320) | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------------------------------------------------| | 3D surface rendering of volume data | shader based slicing algorithms available on typical consumer graphics hardware. Yes, using a standard and well established front-to- back ray-casting algorithm with an iso-surface threshold. | Yes | No | | View manipulating tools | Zoom, Pan, Change of orientation Features and Algorithms identical to SICAT Function | Yes | Zoom, Pan, Change of orientation | | Color manipulating tools | Brightness, Contrast Features and Algorithms identical to SICAT Function | Yes | Brightness, Contrast | | Scrolling through slices | For all slices Features and Algorithms identical to SICAT Function | Yes | For all slices (including panoramic slicing window) | | 3D volume clipping | Yes Features and Algorithms identical to SICAT Function | Yes | Yes | | Length measurement | Yes Features and Algorithms identical to SICAT Function | Yes | Yes | | Area measurement | Yes | Yes | No | | Angle measurement | Yes Features and Algorithms identical to SICAT Function | Yes | Yes | | Overall Length Measurement Accuracy | 100 µm Algorithms identical to SICAT Function | unknown | 100 μm | | Overall Angular Measurement Accuracy | 1 degree Algorithms identical to SICAT Function | unknown | 1 degree | | Segmentation of Anatomical Structures | | | | | Segmentation of anatomical structures | Yes, using a segmentation wizard. Algorithm: Water Shed (a type of graph-cut algorithm, which is identical to SICAT Function ) | Yes Segmentation algorithm is unknown. | Yes, using a segmentation wizard. Algorithm: Water Shed (a type of graph-cut algorithm) | | Airway Segmentation | Airway Segmentation of the Airway using the segmentation wizard. | Yes Segmentation algorithm is unknown. | No | | Segmentation of mandible and fossa | No | No | Yes, using a segmentation wizard. Algorithm: Water Shed (a type of graph-cut algorithm) | {9}------------------------------------------------ | | HICAT Air Proposed | Reference predicate Dolphin Imaging 11.5 (K110430) | Primary predicate SICAT Function (K133320) | |------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Mesh texturing of the segmented airway | The Airway is texturized by a standard algorithm. | Yes | No | | | Optical Impression Data Visualization | | | | Optical impression (maxilla, mandible, or a part thereof) | Optical impression (maxilla, mandible, or a part thereof) | No | Optical impression (maxilla, mandible, or a part thereof) | | | Polygonal mesh in 3D view and panorama view, cut through polygonal mesh (contour) in slice view Features and Algorithms identical to SICAT Function. | | Polygonal mesh in 3D view and panorama view, cut through polygonal mesh (contour) in slice view | | Optical impression name | A list view in a dedicated toolbar contains the names of all loaded optical impressions. Features and Algorithms identical to SICAT Function. | No | A list view in a dedicated toolbar contains the names of all loaded optical impressions. | | Show/Hide an optical impression | Yes Visibility applies to all views simultaneously. Algorithms identical to SICAT Function. | No | Yes Visibility applies to all views simultaneously. | | | Optical Impression Data Manipulation | | | | Registration of surface data (from optical impressions) to volume data | Semi-automatic, using user specified reference points. Features and Algorithms identical to SICAT Function. | No | Semi-automatic, using user specified reference points. | | Fine tuning the accuracy of the registration | Restart of the registration with a different set of reference points. Features and Algorithms identical to SICAT Function. | No | Restart of the registration with a different set of reference points. | | Delete | Yes Features and Algorithms identical to SICAT Function. | No | Yes | | | I/O | | | | Volume data import | DICOM | DICOM | DICOM | | Optical surface data / optical impression import | Standard STL format and proprietary SSI or SIXD container format. Features and Algorithms identical to SICAT Function. | No | Standard STL format and proprietary SSI or SIXD container format. | | Data Import/Export Data Compression | A "study" consisting of planning data (including segmentation information), volume data, optical surface data may be exported and imported in a SICAT proprietary format. Lossless ZIP compression | No | A "study" consisting of planning data (including segmentation information), volume data, jaw motion data and optical surface data may be exported and imported in a SICAT proprietary format. | {10}------------------------------------------------ | | HICAT Air Proposed | Reference predicate Dolphin Imaging 11.5 (K110430) | Primary predicate SICAT Function (K133320) | |------------------------------------------------------------------------------------------------------|---------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------| | | Features and Algorithms identical to SICAT Function. | | Lossless ZIP compression | | Export of data for CAD and rapid proto-typing | Yes | No | Yes | | | | Misc. functions | | | Soft tissue simulation with photo mapping | No | Yes | No | | Cross sections in Multiple Planar View (MPV) | No | Yes | No | | Volume stitching: Combine two separate volumes into one | No | Yes | No | | 2D facial photo wrap onto volume | No | Yes | No | | Volume-to- volume superimposition | No | Yes | No | | 3D nerve marking | No | Yes | No | | Generate panoramic radiographs | Yes | Yes | Yes | | Generate cephalometric radiographs | No | Yes | No | | Create animated movies with automated scripts | No | Yes | No | | Design and print handout reports | Yes | Yes | No | | Image export to other applications | Yes | Yes | Yes | | Main Functions | | | | | Three- dimensional airway segmentation and analysis in the ear-nose throat- region | Yes Image: 3D airway rendering | Yes Image: Display of airway volume and most constricted area | No | | Airway Visualization | 3D surface rendering | 3D surface rendering | No | | Airway Analysis: Calculation of | Yes | Yes | No | {11}------------------------------------------------ | | HICAT Air Proposed | Reference predicate Dolphin Imaging 11.5 (K110430) | Primary predicate SICAT Function (K133320) | |-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| | airway volume | Yes | Yes | No | | Airway Analysis: Calculation of the airway cross section dimensions | Yes | Yes | No | | Airway Analysis: Calculation of the position and size of the area with minimum cross section in airway | Yes | Yes | No | | Simulation of orthodontic procedures, osteotomies and distractions | No | Yes | No | | Cephalometric analysis | No | Yes | No | | TMJ analysis | No | Yes | Yes | | 3D implant treatment planning and simulation | No | Yes | No | | | | Programming Language | | | | C# and C++ | Unknown | C# and C++ | | | | System Requirements | | | PC Hardware Requirements (Minimum) | | Minimum Imaging Requirements (Rev 05/15) | | | | CPU: 2,0 GHz Dualcore | CPU: Intel® Core 2 | CPU: 1 GHz | | | RAM: 4 GB | RAM: 2 GB (4 GB for Dolphin 3D) | RAM: 1 GB | | | HDD: 5 GB free space | HDD: 20 GB free space | HDD: 5 GB free space | | | Video card: Dedicated, DirectX 10 or higher 512 MB video memory Shader Model 3 "INTZ"-Surfaces Current driver | Video card:…