Vitrea Software Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea has the following additional indications:

The Cerebral Aneurysm Analysis application is intended to facilitate the extraction of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.

The MR Wall Motion Tracking application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and regional myocardial function that is used for patients with suspected heart disease.

The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the qualitative and quantitative analysis of coronary arteries.

The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

The Ultrasound Clinical Applications are indication of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.

The Spectral Stone Analysis application is intended to serve as an adjunct visualization tool for the differentiation between uric acid and non-uric acid stones greater than 3 mm with Spectral CT studies acquired on the Canon Medical Systems scanner.

The Spectral Composition Analysis application is intended to assist a physician in visualizing the presence of monosodium urate in anatomical structures. The clinical syndrome of gout is characterized by the presence of monosodium urate crystals in joints or soft tissue.

The Embolization Plan application is a post processing software that is intended to assist physicians in the visualization of the liver arterial tree using 3D images of CT or 3D images of Cone Beam CT acquired by Toshiba or Canon Medical Systems. It provides tools to assist the user in analysis of these images. The output is intended to be an adjunct means that allows automatic and manual planning of the liver arterial vessels for guidance of the embolization procedure. The output is a 3D visualization of the hepatic arteries to high dense lesion in the liver.

The Spectral Analysis application is a CT, non-invasive image analysis software package, which may be used to aid in the visualization of anatomical and pathological materials. The software provides quantification of Hounsfield units of iodine attenuation differences and iodine concentration and display by color.

Effective Z and Electron Density maps may aid in the differentiation of different tissues in the human body.

Device Description

Vitrea Software Package, VSTP-001A, is an application package developed for use on Vitrea, a medical image processing software, marketed by Vital Images, Inc. Vitrea Software Package, VSTP-001A, currently includes ten post processing applications, MR Wall Motion Tracking, Cerebral Aneurysm Analysis, MR Coronary Tracking, SUREVolume Synthesis, Angio Viewer, US Cardiac Fusion, Ultrasound Applications Package, Dual Energy Stone Analysis, Dual Energy Composition Analysis and Embolization Planning Tool which use brain, body or cardiac image data, obtained from CT/XA/MR/US systems, to assist physicians in performing specialized measurements and analysis.

AI/ML Overview

The provided text describes the Vitrea Software Package, VSTP-001A, and its predicate device. This submission focuses on modifications to three specific applications: Spectral Stone Analysis, Spectral Composition Analysis, and Spectral Analysis. The provided text does not contain detailed information about specific acceptance criteria and the comprehensive study results to prove the device meets these criteria in the format requested.

The document is a 510(k) summary, which typically provides a high-level overview of substantial equivalence, and not the full study report with detailed performance metrics.

However, based on the available information, I can infer some aspects and highlight what is missing:

Missing Information:

The document lacks the explicit details for most of your requested points, including:

A clear table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) and corresponding reported performance for the modified spectral analysis features.
Detailed sample sizes used for the test set (number of patients/cases, number of images).
Data provenance beyond the mention of "clinical images" and "phantom studies."
Specific number of experts, their qualifications, and adjudication methods for ground truth.
Whether an MRMC comparative effectiveness study was done or its effect size.
Specific details of standalone algorithm performance.
The exact type of ground truth used (e.g., only expert consensus vs. pathology validation).
Sample size for the training set and how its ground truth was established.

Based on the available text, here's a breakdown of what can be extracted and what remains unknown regarding acceptance criteria and the study:

The submission focuses on modifications to existing features and argues substantial equivalence to a previously cleared device (K192923). The "Testing" section mentions the types of studies conducted but does not provide specific performance results or acceptance criteria in a quantifiable manner.

Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Not Explicitly Stated	The document states "Results of all these studies demonstrate that the features included in this submission meet specifications and perform as intended." However, no specific performance metrics (e.g., sensitivity, specificity, accuracy, precision, recall, AUC) or quantitative acceptance thresholds are provided for any of the modified spectral analysis applications. It implies that the modifications did not degrade the performance previously established for the predicate device.

Acceptance Criterion

Reported Device Performance

Not Explicitly Stated

The document states "Results of all these studies demonstrate that the features included in this submission meet specifications and perform as intended." However, no specific performance metrics (e.g., sensitivity, specificity, accuracy, precision, recall, AUC) or quantitative acceptance thresholds are provided for any of the modified spectral analysis applications. It implies that the modifications did not degrade the performance previously established for the predicate device.

Study Details (Inferred and Missing)

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "clinical images" and "phantom studies" were used, but the number of cases, scans, or images for either is not provided.
- Data Provenance: Not explicitly stated. The document mentions "clinical images," implying real patient data, and "phantom studies." No information about the country of origin, or whether the data was retrospective or prospective, is given.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated. The document mentions "A physician review of clinical images was also performed," but the number of physicians is not specified.
- Qualifications of Experts: Not explicitly stated. The document only refers to "physician," without specifying their specialty (e.g., radiologist, urologist) or years of experience.
Adjudication method for the test set:
- Adjudication Method: Not explicitly stated. It's unknown if multiple readers independently assessed cases and, if so, how disagreements were resolved (e.g., 2+1, 3+1, or simple majority).
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: Not explicitly stated. The primary focus of the submission appears to be on maintaining substantial equivalence of modified features, rather than demonstrating human-AI augmentation. The "physician review" mentioned seems to be for validation of the device outputs rather than a comparative study of human performance with and without the device. The device is described as "adjunct."
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not explicitly stated quantitatively. The emphasis is on the software as an "adjunct visualization tool" to assist physicians. While the software has its own "analysis result display" and "image processing," explicit standalone performance metrics (e.g., for segmentation accuracy or classification) are not provided. The statement "meet specifications and perform as intended" refers to the overall system's function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Inferred to be Expert Consensus for clinical images, and known values for phantom studies. The "physician review of clinical images" suggests expert consensus was a component of ground truth determination for clinical data. For "phantom studies," the ground truth would be precisely known physical properties.
The sample size for the training set:
- Training Set Sample Size: Not mentioned. Standard in 510(k) summary documents, information on training set size and specific details of model development are typically proprietary and not included in this high-level summary.
How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: Not mentioned. As with the training set size, this detail is typically not found in a 510(k) summary.

Summary of what's provided related to "acceptance criteria" and "study":

The document states that "Risk analysis and verification/validation activities conducted through bench testing" and "Additional performance testing, using phantom studies" were performed. It also mentions "A physician review of clinical images" to support a new promotional claim. The overarching conclusion is that "Results of all these studies demonstrate that the features included in this submission meet specifications and perform as intended."

However, the specific quantitative "acceptance criteria" (e.g., a sensitivity threshold of X% or a mean absolute error less than Y) and the detailed results showing how these criteria were met are absent from this 510(k) summary. The document asserts that the modifications to the three spectral analysis applications were evaluated, risks were reduced, and the device performs as intended and is substantially equivalent to its predicate. This assertion implies that internal acceptance criteria were met, but those criteria themselves are not disclosed.

Summary

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February 16, 2021

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

Canon Medical Systems Corporation % Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K203312

Trade/Device Name: Vitrea Software Package, VSTP-001A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: January 27, 2021 Received: January 28, 2021

Dear Mr. Tadeo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K203312

Device Name Vitrea Software Package, VSTP-001A

Indications for Use (Describe)

Vitrea Software Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimens acquired from a variety of imaging devices. Vitrea has the following additional indications:

The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

The Ultrasound Clinical Applications are indication of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.

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attenuation differences and iodine concentration and display by color.

Effective Z and Electron Density maps may aid in the differentiation of different tissues in the human body.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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K203312

510(k) Summary

1. SUBMITTER'S NAME

Fumiaki Teshima Sr. Manager, Quality Assurance Department Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550

1. ESTABLISHMENT REGISTRATION 9614698

OFFICIAL CORRESPONDENT/CONTACT PERSON 3. Orlando Tadeo, Jr. Sr. Manager, Requlatory Affairs Department Canon Medical Systems USA, Inc. 2441 Michelle Dr. Tustin, CA 92780 (714) 669-7459

DATE PREPARED 4. November 06, 2020
1. DEVICE NAME(S) Vitrea Software Package, VSTP-001A
1. TRADE NAME(S) Vitrea Software Package, VSTP-001A
1. COMMON NAME Radiological Image Processing Software

8. DEVICE CLASSIFICATION

Class II (per 21 CFR 892.2050, Picture Archiving and Communications System) Picture Archiving and Communications Systems – Product Code: 90LLZ [per 21 CFR 892.20501

9. PREDICATE DEVICE

Product	Marketedby	RegulationNumber	Regulation Name	ProductCode	510(k)Number	ClearanceDate
Vitrea SoftwarePackage,VSTP-001A*	CanonMedicalSystems,USA	21 CFR892.2050	Picture ArchivingandCommunicationsSystem	LLZ	K192923	10/15/2019

Includes: MR Wall Motion Tracking, Cerebral Aneurysm Analysis, (CT/XA Cerebral Artery Morphological Analysis), MR Coronary Tracking, Synthesis, Angio Viewer, US Cardiac Fusion, Ultrasound Applications Package, Dual Energy Stone Analysis, Dual Energy Composition Analysis, Embolization Planning Tool

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10. REASON FOR SUBMISSION

Modification of an existing medical device.

11. DEVICE DESCRIPTION

12. INDICATIONS FOR USE

The Cerebral Aneurysm Analysis application is intended to facilitate the extraction and segmentation of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.

The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

The Ultrasound Clinical Applications are indicated for the visualization of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.

The Spectral Composition Analysis application is intended to assist a physician in visualizing the presence of monosodium urate in anatomical structures. TThe clinical syndrome of gout is characterized by the presence of monosodium urate crystals in joints or soft tissue.

2441 Michelle Drive, Tustin, CA 92780 PHONE: 800-421-1968 https://us.medical.canon

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The Embolization Plan application is a post processing software that is intended to assist physicians in the visualization of the liver arterial tree using 3D images of CT or 3D images of Cone Beam CT acquired by Toshiba or Canon Medical Systems. It provides tools to assist the user in analysis of these images. The output is intended to be an adjunct means that allows automatic and manual planning of the liver arterial vessels for quidance of the embolization procedure. The output is a 3D visualization of the hepatic arteries to high dense lesion in the liver.

Effective Z and Electron Density maps may aid in the differentiation and characterization of different tissues in the human body.

13. SUBSTANTIAL EQUIVALANCE

The Vitrea Software Package, VSTP-001A, is substantially equivalent to and has the same intended use as the primary predicate device, which received premarket clearance under K192923, and is marketed by Canon Medical Systems USA. The changes being made to the existing device are the modfiication of three applications, Spectral Stone Analysis, Spectral Composition Analysis and Spectral Analysis. The modifications to these three applications were evaluated by risk analysis and a regression review, and it was determined that they were implemented with all risks reduced to an acceptable level.

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*Color Display Function in Spectral Stone Analysis was updated, for the Material Line Preset label to list only "Uric Acid" and "Non Uric Acid

14. SAFETY

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC62304 and IEC60601-1-6.

15. TESTING

Risk analysis and verification/validation activities conducted through bench testing which is included in this submission demonstrate that the established specifications for the device have been met. Additional performance testing, using phantom studies, were conducted to assess the improvements to existing features. A physician review of clinical images was also performed, in order to support a new promotional claim for the previously cleared Spectral Analysis feature, specifically, that spectral iodine maps are designed to assist physicians in visualizing iodine differences in the lung. Results of all these studies demonstrate that the features included in this submission meet specifications and perform as intended. Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also referenced for this submission.

16. CYBERSECURITY

The Vitrea Software Package, VSTP-001A is a portfolio of software applications developed by Canon that are integrated into the Vital Images Vitrea workstations. As such this software has no connections to the internet, wired or wireless networks, etc. All import and export of data is within the domain of the Vital product. Based upon this information it should be noted that CyberSecurity requirements do not apply to this device.

17. CONCLUSION

The software applications modified in the Vitrea Software Package. VSTP-001A, perform in a manner similar to and are intended for the same use as the predicate device. Based upon this information, conformance to standards, successful completion of software validation, application of risk management and design controls and the performance data presented in this submission it is concluded that the subject device is substantially equivalent in safety and effectiveness to the predicate device, Vitrea Software Package, VSTP-001A, 510(k) cleared per K192923.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).

Item	Vitrea Software Package, VSTP-001A (V8.8)	Vitrea Software Package, VSTP-001A (V8.5)
510(k) Number	(Subject Device)	K192923
Anatomical region	Whole body	Whole body
Type of Input Data	Acquired by spectral scan (TSX-306A/3, V10.3 or earlier and V10.4 and later)	Acquired by spectral scan (TSX-306A/3, V10.3 or earlier)
	Spectral Stone Analysis• Monochromatic images	Spectral Stone Analysis• Monochromatic images
	Spectral Composition Analysis• Basis material images and monochromatic image	Spectral Composition Analysis• Basis material images and monochromatic image
	Spectral Analysis• Basis material images and monochromatic image	Spectral Analysis• Basis material images and monochromatic image
Type of Output Data	Spectral Stone Analysis• Analysis result display• Secondary capture (RGB image)Spectral Composition Analysis• Analysis result display• Secondary capture (RGB image)• Batch MPR and DICOM volume save	Spectral Stone Analysis• Analysis result display• Secondary capture (RGB image)Spectral Composition Analysis• Analysis result display• Secondary capture (RGB image)
Item	Vitrea Software Package, VSTP-001A (V8.8)	Vitrea Software Package, VSTP-001A (V8.5)
510(k) Number	(Subject Device)	K192923
	Spectral Analysis• Analysis result display• Secondary capture (RGB image)• Batch MPR and DICOM volume save	Spectral Analysis• Analysis result display• Secondary capture (RGB image)
Image Processing	Spectral Stone Analysis• Visualization of the differentiationbetween uric acid and non-uric acidstones	Spectral Stone Analysis• Visualization of the differentiationbetween uric acid and non-uric acidstones
	Spectral Composition Analysis• Visualization of monosodium uratepresence within surrounding anatomicalstructures	Spectral Composition Analysis• Visualization of monosodium uratepresence within surrounding anatomicalstructures
	Spectral Analysis• Generation of monochromatic images(ranging from 35keV – 200keV)o Smoothing filter• Generation of lodine map• VNC image• Generation of Electron Density Image• Generation of Effective Z Image• Generation of Basis material image (bone/water)	Spectral Analysis• Generation of monochromatic images(ranging from 35keV - 135keV)• Generation of lodine map• VNC image• Generation of Electron Density Image• Generation of Effective Z Image
Analysis	Segmentation
	Spectral Stone Analysis• The region included in the range of setCT numbers is extracted.	Spectral Stone Analysis• The region included in the range of setCT numbers is extracted.
	Spectral Composition Analysis• The compositions are extracted basedon the composition setting.	Spectral Composition Analysis• The compositions are extracted basedon the composition setting.
	Spectral Analysis• Monochromatic imageo Basis material dual energy analysis• lodine mapo Three material decomposition• Electron densityo Basis material dual energy analysis• Effective Zo Basis material dual energy analysis• Basis material image (bone/water)o Basis material dual energy analysis	Spectral Analysis• Monochromatic imageo Basis material dual energy analysis• lodine mapo Three material decomposition• Electron densityo Basis material dual energy analysis• Effective Zo Basis material dual energy analysis
Item	Vitrea Software Package, VSTP-001A (V8.8)	Vitrea Software Package, VSTP-001A (V8.5)
510(k) Number	(Subject Device)	K192923
Display	Spectral Stone Analysis*• MPR	Spectral Stone Analysis• MPR
	Spectral Composition Analysis• MPR, 3D	Spectral Composition Analysis• MPR, 3D
	Spectral Analysis• MPR, Fusion image, MIP image, MinIP image, Displaying three MPR planes	Spectral Analysis• MPR, Fusion image