AutoSeg-H is medical imaging software that is intended to professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. AutoSeg-H accepts DICOM compliant medical images acquired from imaging device (Computed Tomography).

AutoSeg-H provides the tools for specific analysis applications which provide custom UI, targeted measurements and reporting functions including:

Coronary Artery Analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries.
Valve Analysis: which is intended for automatic extraction of the heart and aorta regions, automatic detection of the contour of the aorta and valves, measurement of the vicinity of the valves.
4-Chamber Analysis: which is intended for automatic extraction of the left atrium, and right ventricle from CT.

Device Description

AutoSeg-H(V1.0.0.01) is software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning. AutoSeg-H(V1.0.0.01) runs on Windows standalone installed on a commercial general-purpose Windows-compatible computer and accepts DICOM compliant medical images acquired from a CT. The AutoSeg-H is not connected to a PACS system directly but retrieves saved image data from a computer. Image data obtained from the computer are used for display, image processing, analysis, etc. AutoSeg-H cannot be used to interpret Mammography images.

The main functions of AutoSeg-H are shown below.

Coronary Artery Analysis (CT) -
Aortic Valve Analysis (CT) -
-4-Chamber Analysis (CT)

AI/ML Overview

The provided text details the 510(k) summary for the AutoSeg-H device. As per the document, no clinical studies were performed. The non-clinical performance testing focused on verifying that the software met performance test criteria, functioned without errors, and met standards for estimating quantitative measurement and segmentation algorithm errors. The details regarding acceptance criteria, study design, and ground truth establishment for a standalone algorithm performance or comparative effectiveness study are not explicitly provided in the furnished document.

However, based on the Non-Clinical Test Summary, we can infer some aspects of the performance evaluation.

Here's an attempt to answer your questions based only on the provided text, noting where information is explicitly stated or absent:

1. A table of acceptance criteria and the reported device performance

The document states: "Through the performance test, it was confirmed that AutoSeg-H meets all performance test criteria and that all functions work without errors. Test results support the conclusion that actual device performance satisfies the design intent and is equivalent to its predicate device."

Acceptance Criteria: While specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or error tolerances) are not explicitly detailed in the provided text, the criteria are broadly described as:
- Meeting "all performance test criteria."
- Ensuring "all functions are operating without errors."
- Meeting "test standards which estimation of the quantitative measurement error."
- Meeting "test standards which estimation of segmentation algorithm error."
Reported Device Performance: The reported performance is a qualitative statement of meeting these unquantified criteria. No specific metrics or numerical results are provided in this summary.

Acceptance Criterion (Inferred from text)	Reported Device Performance
Meets all performance test criteria	Confirmed to meet.
All functions operate without errors	Confirmed to work without errors.
Meets standards for quantitative measurement error estimation	Confirmed to meet.
Meets standards for segmentation algorithm error estimation	Confirmed to meet.
Satisfies design intent and is equivalent to predicate device	Confirmed to satisfy design intent and equivalent predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the sample size (number of cases or images) used for the non-clinical performance testing.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states that the device accepts "DICOM compliant medical images acquired from imaging device (Computed Tomography)."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide information on the number or qualifications of experts used to establish ground truth for the non-clinical test set. The testing appears to be primarily software verification against pre-defined performance and error estimation standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method for establishing ground truth, as it does not mention human readers or expert consensus for ground truth generation in the non-clinical testing. The "Test results were reviewed by designated technical professionals," but this refers to reviewing the software test outcomes, not establishing medical ground truth for image interpretation.

5. 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

The document explicitly states: "No clinical studies were considered necessary and performed." Therefore, no MRMC comparative effectiveness study was done.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the non-clinical performance testing described seems to be a standalone (algorithm only) evaluation. The tests were conducted to "confirm that AutoSeg-H meets all performance test criteria and all functions are operating without errors," and to "confirm that AutoSeg-H meets test standards which estimation of the quantitative measurement error" and "segmentation algorithm error." This suggests an evaluation of the algorithm's output against defined standards or computational accuracy, rather than human-in-the-loop performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document largely discusses testing against "performance test criteria" and "test standards which estimation of the quantitative measurement error" and "segmentation algorithm error." This implies that the 'ground truth' for the non-clinical tests would involve computational benchmarks, reference measurements, or predefined correct segmentations, rather than medical ground truth established by expert consensus, pathology, or outcomes data. The core technology is described as an "advanced active contour algorithm with entropy regularization," suggesting validation against known segmentation accuracy targets.

8. The sample size for the training set

The document does not provide any information regarding the training set's sample size.

9. How the ground truth for the training set was established

The document does not provide any information regarding how the ground truth for the training set was established.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

AI Medic Inc. % Jeong Song COO 2F, 437, Bongeunsa-ro, Gangnam-gu Seoul, KS013/06097 REPUBLIC OF KOREA

Re: K220039

July 20, 2022

Trade/Device Name: AutoSeg-H Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: June 21, 2022 Received: June 28, 2022

Dear Jeong Song:

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 medical devices and radiation-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,

Jessica Lamb. Ph.D. Assistant Director DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of 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) K220039

Device Name AutoSeg-H

Indications for Use (Describe)

AutoSeg-H provides the tools for specific analysis applications which provide custom UI, targeted measurements and reporting functions including:

Coronary Artery Analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries.
Valve Analysis: which is intended for automatic extraction of the heart and aorta regions, automatic detection of the contour of the aorta and valves, measurement of the vicinity of the valves.
4-Chamber Analysis: which is intended for automatic extraction of the left atrium, and right ventricle from CT.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K220039

Image /page/3/Picture/1 description: The image shows the logo for AiMEDIC. The logo consists of a red geometric shape on the left, resembling a stylized plus sign or a four-petal flower. To the right of the shape is the text "AiMEDIC" in a gray, sans-serif font, with a red dot above the letter "i".

2F, 437, Bongeunsa-ro, Gangnam-gu, Seoul, 06097, Republic of Korea Tel: +82-(0)2-568-2667 Fax:+82-(0)2-548-2667

510(k) Summary

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

July 11, 2022

Submitter's Information & Contact Person [21 CFR 807.92(a)(1)] 2.

Name of Manufacturer: AI Medic Inc.
Address: 2F, 437, Bongeunsa-ro, Gangnam-gu, Seoul, 06097, Republic of Korea
Contact Name: Jeong Soon Song/COO
Telephone No.: +82-2-568-2667
Fax No.: +82-2-548-2667
Email Address: song@aimedic.kr

Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] 3.

Common name: Picture archiving and communications system (PACS) Trade name: AutoSeg-H (Model: AutoSeg-H)

Classification Description	21 CFR Section	Product Code
System, Image Processing, Radiological	21 CFR 892.2050	LLZ

As stated in 21 CFR parts 892.2050 of the device has been classified as Class II.

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Image /page/4/Picture/0 description: The image shows the logo for AiMEDIC. The logo consists of a red geometric shape on the left, resembling a stylized plus sign or a four-pointed star. To the right of the geometric shape is the text "AiMEDIC" in gray, with a red dot above the "i". The logo appears to be clean and modern.

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate devices within this submission are shown as follow:

Predicate device

510(k) Number: K200973 ●
Applicant: FUJIFILM Corporation .
Classification Name: System, Image Processing, Radiological .
Trade Name: Synapse 3D Cardiac Tools
. Common Name: Picture archiving and communications system (PACS)

5. Description of the Device [21 CFR 807.92(a)(4)]

5.1 Overview

The main functions of AutoSeg-H are shown below.

Coronary Artery Analysis (CT) -
Aortic Valve Analysis (CT) -
-4-Chamber Analysis (CT)

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AutoSeg-H Block Diagram
The connection configurations for AutoSeg-H are shown below.
· AutoSeg-H operates on a window.
· AutoSeg-H reads the CT DICOM image from its own device and analyzes them. (Standalone configuration)

Image /page/5/Figure/6 description: The image shows a diagram of a process flow on a local PC. The process starts with input, which includes Cardiac CT DICOM data and user interaction. The input is then processed, and the output includes 2D images (CPR, Cross-section, Coronary, Aorta, 4-Chamber), 3D images (Coronary, Aorta, 4-Chamber), information (Stenosis Ratio, Measured Information), and an option to export and save the result.

Fig. Block Diagram

AutoSeg-H algorithm description
The software employs an advanced active contour algorithm with entropy regularization, to implement semantic segmentation of target organs. The execution of this method results in 3D reconstruction of target organs.

5.2 AutoSeg-H Applications

In the configurations shown in Block diagram(Fig) offers trained medical professionals the following applications to analyze the image data retrieved from Computed tomography.

General Applications ●
- 1. Menu

In the Menu application, user can import DICOM, load previous work file, extract 3D model, and save work files.

1. 2D Viewer
  The 2D Viewer can show axial view, sagittal view, coronary artery, aorta, and 4-chamber.

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3D Viewer (3D reconstruction) 3.
The 3D Viewer can show 3D reconstructed coronary artery, aorta, and 4-chamber.
1. Measurement
  The Measurement application can show what the user measured like distance between two points, angle, area. and perimeter of 2D and 3D view etc.
Manual Image Modification (Editing) 5.
By the modification application, users can select, draw, modify, and label specific areas on 2D or 3D view etc. .
1. Sequential Display
  The Sequential Display, sequentially displays a cross section of specified area. (Angle, play range, speed, direction can be set)
1. Setting
  In the Setting application, users can set brightness, initialize histogram, sync images, set 3D reconstruction image as volume, solid mesh and wire frame view, turn on/off patient information, coordinate display, crosshair and 3D view.

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Analysis Applications
- 1. Coronary Artery Analysis

The Coronary Artery Analysis application can reconstruct 3D Coronary Artery, display Cross section view, analyze Stenosis ratio, initialize the layout and turn on/off the Coronary Artery, Coronary Inner line.

1. Aortic Valve Analysis
  The Aortic Valve Analysis application can reconstruct 3D Aorta, mark the centerline, measure long axis, short axis, area, perimeter, and rotate the 3D image. Also can switch to the default layout, manually select the measurement location, initialize/save/display the measurement result.
1. 4-Chamber Analysis
  The 4-Chamber Analysis application can reconstruct 3D left atrium, left ventricle, right atrium, and right ventricle.

5.3 Technical Characteristics and principles of operations

Predicate Device: A software program used for medical image analysis, of which segmentation method is based on a graphical model for pattern recognition.

Subject Device: A software program used for medical image analysis, of which segmentation method is based on an advanced active contour algorithm for pattern recognition.

Different equations of safety and effectiveness? No

Why: Since both devices receive input data as DICOM compliant CT images and handle it with numerical algorithms, there is no specific reason for raising new or different questions of safety and effectiveness although the new device features different technical characteristics and principles of operations.

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6. Indications for Use [21 CFR 807.92(a)(5)]

AutoSex-H is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. AutoSeg-H accepts DICOM compliant medical images acquired from imaging device (Computed Tomography).

AutoSeg-H provides the tools for specific analysis applications which provide custom UI, targeted measurements and reporting functions including:

Coronary Artery Analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries.
Valve Analysis: which is intended for automatic extraction of the heart and aorta regions, automatic detection of the contour of the aorta and valves, measurement of the vicinity of the valves.
4-Chamber Analysis: which is intended for automatic extraction of the left atrium, left ventricle, right atrium, and right ventricle from CT.

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7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) (6) and 21 CFR 807.92(b)]

The identified predicate device within this submission are shown in the following table:

	Proposed Device	Predicate Device	SE decision
K Number	K220039	K200973	-
Manufacturer	AI Medic Inc.	FUJIFILM Corporation.	-
Trade name	AutoSeg-H	Synapse 3D Cardiac Tools
Model	AutoSeg-H	V5.4
Product Code	LLZ	LLZ	Same
Regulatory Class	Class II	Class II	Same
Regulation Number	21 CFR 892.2050		Same
Indications for Use	AutoSeg-H is medical imaging softwarethat is intended to provide trained medicalprofessionals with tools to aid them inreading, interpreting, reporting, andtreatment planning. AutoSeg-H acceptsDICOM compliant medical imagesacquired from imaging device (ComputedTomography).AutoSeg-H provides the tools for specificanalysis applications which providecustom UI, targeted measurements andreporting functions including:- Coronary Artery Analysis for CTcoronary arteriography images: which isintended for the qualitative andquantitative analysis of coronary arteries.- Valve Analysis: which is intended forautomatic extraction of the heart and aortaregions, automatic detection of thecontour of the aorta and valves,measurement of the vicinity of the valves.- 4-Chamber Analysis: which is intendedfor automatic extraction of the left atrium,left ventricle, right atrium, and rightventricle from CT.	Synapse 3D Cardiac Tools is medicalimaging software used with Synapse 3DBase Tools that is intended to providetrained medical professionals with toolsto aid them in reading interpreting,reporting, and treatment planning,Synapse 3D Cardiac Tools acceptsDICOM compliant medical imagesacquired from a variety of imagingdevices including, CT, MR, NM, and XA.This product is not intended for use withor for the primary diagnosticinterpretation of Mammography images.Addition to the tools in Synapse 3D BaseTools, Synapse 3D Cardiac Toolsprovides the tools for specific clinicalapplications which provide targetedworkflows, custom UI, targetedmeasurements and reporting functionsincluding:- Functional cardiac analysis for CT leftventriculography images: which isintended to evaluate the functionalcharacteristics of heart.- Functional cardiac analysis for MRheart images: which is intended toevaluate the functional characteristics ofheart.- Coronary artery analysis for CTcoronary arteriography images which is	Same
		2F, 437, Bongeunsa-ro, Gangnam-gu, Seoul, 06097, Republic of KoreaTel: +82-(0)2-568-2667 Fax:+82-(0)2-548-2667intended for the qualitative andquantitative analysis of coronary arteries.Coronary artery analysis for MR heartimages: which is intended for thequalitative and quantitative analysis ofcoronary arteries.Calcium scoring for non-contrast CTheart images: which is intended for non-invasive identification and quantificationof calcified atherosclerotic plaques in thecoronary arteries using tomographicmedical image data and clinicallyaccepted calcium scoring algorithms.Cardiac Fusion: which is intended toanalyze cardiac anatomy and pathologywith a fused image of functional data (e.g.NM image, Bulls eye) and anatomicaldata.Valve Analysis: which is intended forautomatic extraction of the heart and aortaregions, automatic detection of thecontour of the aorta and valves,measurement of the vicinity of the valves,measurement of the calcification area inthe aorta and the valves. Placement of avirtual prosthetic valve.MR parametric maps: which isprovided for pixel maps for myocardialMR relaxation times.
Users	Healthcare Professionals	Healthcare Professionals	Same
DICOM compliantmedical images	CT	CT, MR, NM and XA
Imaging Capabilities	2D, 3D	2D, 3D	Same
Function	Coronary Artery Analysis (CT), AorticValve Analysis (CT), 4-ChamberAnalysis (CT)	Cardiac Function(CT,MR), CoronaryArtery Analysis(CT,MR), CalciumScoring, Cardiac Fusion, Aortic ValveAnalysis, MR Flow Analysis(MR), 4-Chamber Analysis(CT), Cardiac AblationAnalysis(CT), Cardiac Tx-maps, MitralValve Analysis
Product Availability	Software Product	Software Product	Same
Hardware Platform	Windows PC	Windows PC	Same
Operating System	Windows 10(x64)	Microsoft Windows 10 (x64, x86)Microsoft Windows 8.1 (x86, x64)

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DiC AT

2F, 437, Bongeunsa-ro, Gangnam-gu, Seoul, 06097, Republic of Korea

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Image /page/11/Picture/0 description: The image shows the logo for AiMEDIC. The logo consists of a red geometric shape on the left, resembling a stylized plus sign or a four-pointed star. To the right of the shape is the text "AiMEDIC" in gray, with a red dot above the letter "i". The logo appears to be clean and modern, suggesting a company involved in technology or healthcare.

2F, 437, Bongeunsa-ro, Gangnam-gu, Seoul, 06097, Republic of Korea

Tel: +82-(0)2-568-2667 Fax:+82-(0)2-548-2667

		Microsoft Windows 7 Professional (x86, x64) SP1
	Digital Imaging and Communications inMedicine (DICOM) Set (Ps3.1 - .20)	Digital Imaging and Communications inMedicine (DICOM) Set (Ps3.1 - .20)
PerformanceStandards	AAMI/ANSI/IEC 62304:2006, MedicalDevice Software	AAMI/ANSI/IEC 62304:2006, MedicalDevice Software	Same
	ISO 14971 Second Edition 2007-03-01,Medical Devices	ISO 14971 Second Edition 2007-03-01,Medical Devices
Core Technology andAlgorithm	Segmentation Method Based onAdvanced Active Contour AlgorithmThe software employs an advanced activecontour algorithm with entropyregularization, to implement semanticsegmentation of target organs. Theexecution of this method results in 3Dreconstruction of target organs.	The segmentation algorithm is a kind ofgraphical model solving energyminimization problem in terms ofimage energies, providing 3Dreconstruction of target organs.	Same

Non-Clinical Test Summary [21 CFR 807.92(b)(1)]

Non-clinical performance testing has been performed in compliance with the following International and FDArecognized consensus standards and FDA guidance document:

ISO 14971 Second Edition 2007-03-01, Medical Devices - Application of Risk Management to Medical Devices
AAMI/ANSI/IEC 62304:2006, Medical Device Software - Software Life Cycle Processes
Digital Imaging and Communications in Medicine (DICOM) Set (PS 3.1 - 3.20) (2016)
Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Performance tests were conducted for the following purposes:

To confirm that AutoSeg-H meets all performance test criteria and all functions are operating without errors.
To confirm that AutoSeg-H meets test standards which estimation of the quantitative measurement error.
To confirm that AutoSeg-H meets test standards which estimation of segmentation algorithm error.

Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to formalize after ensuring that the software fully satisfies all expected and previously defined system requirements and features.

Through the performance test, it was confirmed that AutoSeg-H meets all performance test criteria and that all functions work without errors. Test results support the conclusion that actual device performance satisfies the design intent and is equivalent to its predicate device.

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Image /page/12/Picture/0 description: The image shows the logo for AiMEDIC. The logo consists of a red geometric shape on the left, resembling a plus sign made of four diamonds. To the right of the geometric shape is the text "AiMEDIC" in gray, with a red dot above the "i". The logo appears to be for a medical or technology-related company.

Clinical Test Summary [21 CFR 807.92(b)(2)]

No clinical studies were considered necessary and performed.

Conclusion [21 CFR 807.92(b)(3)] 8.

In conclusion, the tests conducted, as well as all verification activities, demonstrate that the design specifications and technological characteristics of AutoSeg-H meet applicable requirements and standards for the safety and effectiveness of the device for its intended use. There are some differences in technological characteristics between the predicates and proposed device, but those differences do not raise new or different questions of safety or effectiveness as compared to the predicate devices. Therefore, AutoSeg-H is substantially equivalent to the currently marketed predicate device.

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).