Brainlab Elements are software applications indicated for the processing of medical image data to support the intended user group to perform image guided surgery and radiation treatment planning.

Brainlab Elements Contouring provides an interface with tools and views to outline, refine, combine and manipulate structures in patient image data. The generated 3D structures are not intended to create physical replicas used for diagnostic purposes.

Brainlab Elements Image Fusion is an application for the co-registration of image data within medical procedures by using rigid and deformable registration methods. It is intended to align anatomical structures between data sets.

Brainlab Elements Fibertracking is an application of cranial white matter tracts based on Diffusion Tensor Imaging (DTI) data for use in treatment planning procedures.

Brainlab Elements BOLD MRI Mapping provides tools to analyze task based blood oxygen level dependent data (BOLD MRI Data) to visualize the activation signal.

Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-registration of cerebrovascular image data.

Device Description

The Brainlab Elements 6.0 are applications that transfer DICOM data to and from picture archiving and communication systems (PACS) and other storage media devices. They include modules for 2D & 3D image viewinq, imaqe processing, image co-registration, image seqmentation and 3D visualization of medical image data for treatment planning procedures.

They consist of the following software applications:

1. Contouring 4.5
1. Imaqe Fusion 4.5
1. Fibertracking 2.0
1. BOLD MRI Mapping 1.0
1. Image Fusion Angio 1.0

This device is a successor of the Predicate Device Brainlab Elements 5.0 (K212420).

Brainlab Elements Contouring provides an interface with tools and views to outline, edit, refine, combine and manipulate structures in patient image data. The output is saved as 3D DICOM seqmentation object and can be used for further processing and treatment planning.

Brainlab Elements Image Fusion is an application for the co-registration of image data within medical procedures by using rigid and deformable registration methods.

The co-registration consists on providing spatial alignment/fusion of medical imaging data, which are derived from different or same imaging modalities (e.g. CT, MRI, PET, SPECT, US). Once two image sets are fused, they can be viewed simultaneously. All planned content (e.g. objects and trajectories) defined in one image set is visible in any other fused image set. The algorithm used in Image Fusion matches two image sets together with common anatomical structures for optimal fusion results. Therefore, the two image sets must share the same common anatomical area.

Brainlab Elements Fibertracking is an application for the processing and visualization of information based upon Diffusion Tensor Imaging (DTI) data, i.e. to calculate and visualize cranial white matter tracts in selected regions of interest, which can be used for treatment planning procedures.

Diffusion Tensor Imaging (DTI) is a magnetic resonance technique, that allows the measurement of diffusion anisotropy in the brain using diffusion weighted images that were scanned with magnetic field gradients applied in several directions. The Fibertracking software uses the scans to calculate the diffusion direction of the water molecules alonq potential white matter fibers for the entire data volume.

Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-registration of cerebrovascular image data. It allows to register digital subtraction anqiographies to vascular images in order to combine flow and location information. In particular, 2D DSA (digital subtraction angiography) sequences can be fused to MRA, CTA and 3D DSA sequences.

AI/ML Overview

The provided text is a 510(k) Summary for Brainlab Elements 6.0 and related applications. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices, including an older version of Brainlab Elements and iPlan.

However, the document does not contain the detailed performance study information requested in your prompt. Specifically, it lacks:

A table of acceptance criteria and reported device performance. The document states "Verification and validation activities carried out established that the set requirements were met and that the device performs as claimed," but does not provide specific metrics or a table.
Sample size and data provenance for a test set. It mentions a "test pool data" set aside for AI/ML algorithm evaluation but gives no size or details on provenance.
Number and qualifications of experts for ground truth.
Adjudication method for the test set.
Details on any MRMC comparative effectiveness study, including effect size.
Specific standalone performance results for the algorithm.
Type of ground truth used (e.g., pathology, outcomes).
Sample size and ground truth establishment for the training set.

The document primarily focuses on software verification and general clinical validation conclusions (e.g., "All applicable safety and performance requirements are fulfilled," "Clinical data collected establishes the performance and safety"). It mentions an AI/ML algorithm for tumor segmentation but provides no details on its performance, training, or testing methodology beyond general statements.

Therefore, based solely on the provided text, it is not possible to answer your request for specific acceptance criteria and detailed proof of meeting those criteria. The document contains general statements about validation and verification but lacks the specific quantitative and methodological details needed to fill out your requested table and information points.

Summary

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

July 14, 2023

Brainlab AG % Marc Bergenthal Manager Regulatory Affairs Olof-Palme-Str. 9 Munich, 81829 GERMANY

Re: K223106

Trade/Device Name: Brainlab Elements 6.0, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio, Brainlab Elements Contouring, Brainlab Elements BOLD MRI Mapping, Brainlab Elements Fibertracking Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH, LLZ, JAK Dated: June 23, 2023 Received: June 23, 2023

Dear Marc Bergenthal:

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.

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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 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.

D.G.K.

Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: 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) K223106

Device Name

Brainlab Elements 6.0, Brainlab Elements Image Fusion Ango, Brainlab Elements Contouring, Brainlab Elements BOLD MRI Mapping, Brainlab Elements Fibertracking

Indications for Use (Describe)

Brainlab Elements are software applications indicated for the processing of medical image data to support the intended user group to perform image guided surgery and radiation treatment planning.

Brainlab Elements Fibertracking is an application of cranial white matter tracts based on Diffusion Tensor Imaging (DTI) data for use in treatment planning procedures.

Brainlab Elements BOLD MRI Mapping provides tools to analyze task based blood oxygen level dependent data (BOLD MRI Data) to visualize the activation signal.

Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-registration of cerebrovascular image data.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized pink caduceus symbol on the left, followed by the word "BRAINLAB" in large, bold, pink letters. The caduceus symbol appears to be a stylized representation of a snake wrapped around a staff, commonly associated with medicine and healthcare.

K223106

510(k) Summary

July 14, 2023

General Information
Manufacturer	Brainlab AG; Olof-Palme Str.9; 81829, Munich, Germany
Establishment Registration	8043933
Trade Names	Brainlab Elements Image Fusion Brainlab Elements Image Fusion Angio Brainlab Elements Contouring Brainlab Elements BOLD MRI Mapping Brainlab Elements Fibertracking
Classification Name	Medical image management and processing system
Product Code (primary)	QIH
Product Codes(secondary)	LLZ, JAK
Regulation Number	892.2050
Regulatory Class	II
Panel	Radiology
Primary Predicate Device	K212420Brainlab Elements, Brainlab Elements Contouring (4.0), BrainlabElements Fibertracking (2.0), Brainlab Elements Image Fusion(4.0), Brainlab Elements Image Fusion Angio (1.0)
Secondary PredicateDevice	K113732iPlan (iPlan Cranial, iPlan Stereotaxy, iPlan ENT, iPlan CMF, iPlanView, iPlan Spine)
Contact Information
Primary Contact	Marc BergenthalManager Regulatory AffairsRegulatory AffairsPhone: +49 89 99 15 68 0Email: regulatory.affairs@brainlab.com
Alternate Contact	Sadwini SureshQM ConsultantPhone: +49 89 99 15 68 0Email: regulatory.affairs@brainlab.com

1. Indication for Use

Brainlab Elements are software applications indicated for the processing of medical image data to support the intended user group to perform image guided surgery and radiation treatment planning.

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Image /page/4/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized pink brain-like symbol on the left, followed by the word "BRAINLAB" in pink, block letters. The brain symbol is made up of three curved lines that resemble the folds of a brain.

Brainlab Elements Fibertracking is an application for the processing and visualization of cranial white matter tracts based on Diffusion Tensor Imaging (DTI) data for use in treatment planning procedures.

Brainlab Elements BOLD MRI Mapping provides tools to analyze task based blood oxygen level dependent data (BOLD MRI Data) to visualize the activation signal.

Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-reqistration of cerebrovascular image data.

2. Device Description

They consist of the following software applications:

1. Contouring 4.5
1. Imaqe Fusion 4.5
1. Fibertracking 2.0
1. BOLD MRI Mapping 1.0
1. Image Fusion Angio 1.0

This device is a successor of the Predicate Device Brainlab Elements 5.0 (K212420).

Brainlab Elements Image Fusion is an application for the co-registration of image data within medical procedures by using rigid and deformable registration methods.

Brainlab Elements Fibertracking is an application for the processing and visualization of information based upon Diffusion Tensor Imaging (DTI) data, i.e. to calculate and visualize

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cranial white matter tracts in selected regions of interest, which can be used for treatment planning procedures.

Al Features:

Artificial Intelligence features included for the device refers to the identification of previously diagnosed lesions or tumors in T1-Weighted Contrast-Enhanced Magnetic Resonance (T1+C MR) volumetric images.

Such functionality was already present in previous versions of the devices, where it was based on a tumor segmentation algorithm without machine learning. As research has shown that tumor segmentation algorithms based on Al / ML can achieve better performance metrics than non-machine learning algorithms, the tumor seqmentation algorithm is complemented with an AI / ML based algorithm that is preferred in case suitable T1+C MR volumes are provided to a device.

The Al/ML algorithm is a Convolutional Network (CNN) developed using a Supervised Learning approach. The algorithm was developed using a controlled internal process that defines activities from the inspection of input data to the training and verification of the algorithm.

The training process begins with the model observing, and optimizing its parameters based on the training pool data. The model's prediction and performance are then evaluated aqainst the test pool. The test pool data is set aside at the beginning of the project.

3. Substantial Equivalence

The Subject Device has similar intended use and technological features as the predicate devices. An overview of the similarities and differences can be found in the tables below:

Predicate Device	Name
Subject Device	Brainlab Elements, Brainlab Elements Contouring (4.5), BrainlabElements Fibertracking (2.0), Brainlab Elements Image Fusion (4.5),Brainlab Elements Image Fusion Angio (1.0), Brainlab Elements BOLDMRI Mapping (1.0)

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Image /page/6/Picture/0 description: The image shows the word "BRAINLAB" in pink font. To the left of the word is a pink symbol that looks like a caduceus. The symbol is a stylized version of the traditional medical symbol, with three intertwined snakes instead of two. The word "BRAINLAB" is written in all capital letters and is in a bold, sans-serif font.

Predicate Device	Name
Primary Predicatedevice (K212420)	Brainlab Elements, Brainlab Elements Contouring (4.0), BrainlabElements Fibertracking (2.0), Brainlab Elements Image Fusion (4.0),Brainlab Elements Image Fusion Angio (1.0)
SecondaryPredicate device(K113732)	iPlan (iPlan Cranial, iPlan Stereotaxy, iPlan ENT, iPlan CMF, iPlan View,iPlan Spine)

Brainlab Elements – Image Fusion 4.5

Topic/ Feature	Primary Predicate Device(Brainlab Elements Image Fusion4.0 (K212420))	Subject Device (BrainlabElements Image Fusion 4.5)	Comment
Indications for use	Brainlab Elements Image Fusionis an application for the co-registration of image data withinmedical procedures by usingrigid and deformable registrationmethods. It is intended to alignanatomical structures betweendata sets.The device itself does not haveclinical indications.	Brainlab Elements ImageFusion is an application forthe co-registration of imagedata within medicalprocedures by using rigidand deformable registrationmethods. It is intended toalign anatomical structuresbetween data sets.The device itself does nothave clinical indications.	Same as thepredicate.
Use Environment	The system shall be used in ahospital office environment orrooms appropriate for surgicalinterventions or radiotherapyplanning.	The system shall be used ina hospital officeenvironment or roomsappropriate for surgicalinterventions orradiotherapy planning.	Same as thepredicate.
ComputerHardwareRequirements	Brainlab Elements can be usedon hardware that fulfills thedefined minimum requirements:- Operating System:Windows 8.1 64bit- Minimum 4 logical cores- Minimum RAM: 6 GB- Graphics: Direct X- compatible	Brainlab Elements can beused on hardware thatfulfills the defined minimumrequirements:- Operating System:Windows 8.1 64bit- Minimum 4 logicalcores	Same as thepredicate.

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-	- Display Resolution: 1920x 1080 (Full HD)	- Minimum RAM: 6GB- Graphics: Direct Xcompatible- Display Resolution:1920 x 1080 (Full HD)	-
Image Data SetsFormat	DICOM 3D imaging Modalities,e.g. CT/XT, MRI, NM/PET, OT,are supported for automaticfusion.Other modalities are supportedfor manual fusion (alignment)	DICOM 3D imagingModalities, e.g. CT/XT, MRI,NM/PET, OT, are supportedfor automatic fusion.Other modalities aresupported for manual fusion(alignment)	Same as thepredicate.
Rigid co-registration, rigidimage fusion	Automatic rigid co-registration(rigid fusion) of 3D DICOM imagedata: CT (incl. low-dose CT), MR,OT (e.g. Perfusion), MR-DTI, MR-BOLD, NM/PETManual rigid co-registration (rigidfusion) of other (unknown) 3DDICOM image data, e.g. US(ultrasound).	Automatic rigid co-registration (rigid fusion) of3D DICOM image data: CT(incl. low-dose CT), MR, OT(e.g. Perfusion), MR-DTI,MR-BOLD, NM/PET, US(ultrasound).Manual rigid co-registration(rigid fusion) of other(unknown) 3D DICOMimage data.	The subject deviceadditionallyprovidesfunctionality toautomatically fuseUS to MR images.Safety and efficacyof this feature wasverified via RiskManagement andVerificationactivities.

Brainlab Elements Contouring 4.5

Topic/ Feature	Primary Predicate Device(Brainlab Elements Image Fusion4.0 (K212420))	Subject Device (Contouring4.5)	Comment
Indications for Use	Brainlab Elements Contouringprovides an interface with toolsand views to outline, refine,combine and manipulatestructures in patient image data.The generated 3D structures arenot intended to create physicalreplicas used for diagnosticpurposes.	Brainlab ElementsContouring provides aninterface with tools andviews to outline, refine,combine and manipulatestructures in patient imagedata. The generated 3Dstructures are not intendedto create physical replicas	Same as thepredicate.
Use Environment	The device itself does not haveclinical indicationsThe system shall be used in ahospital office environment orrooms appropriate for surgicalinterventions or radiotherapyplanning.	used for diagnosticpurposes.The device itself does not haveclinical indicationsThe system shall be used ina hospital officeenvironment or roomsappropriate for surgicalinterventions orradiotherapy planning.	Same as thepredicate.
AutomaticSegmentation ofObjects	The application automaticallycreates segmentation objectsprovided by the Universal Atlas.Workflow relevant segmentationobjects are created automaticallyor, if required by a workflow, ona single button click.The application also offers thepossibility to define customizedsegmentation templates.	The applicationautomatically createssegmentation objectsprovided by the UniversalAtlas.Workflow relevantsegmentation objects arecreated automatically or, ifrequired by a workflow, ona single button click.The application also offersthe possibility to definecustomized segmentationtemplates.	Same as thepredicate.
Manual Creationand Refinement ofObjects	The application provides tools forthe manipulation of objects:The application provides tools formanual creation and refinementof segmentation objects:- SmartShaper- Brush 3D / Erase 3D- Brush 2D / Erase 2D- Smart Brush- Threshold Segmentation	The application providestools for the manipulation ofobjects:The application providestools for manual creationand refinement ofsegmentation objects:- SmartShaper- Brush 3D / Erase 3D- Brush 2D / Erase 2D- Smart Brush- Threshold- Segmentation	Same as thepredicate.
Object Manipulation	The application provides tools forthe manipulation of objects:Copy	The application providestools for the manipulation ofobjects:	Same as thepredicate.
-	Margins-Smoothing-Mirroring-Shifting and Rotation-Splitting-Automatic Object Fitting	Copy-Margins-Smoothing-Mirroring-Shifting and-Rotation-Splitting-Automatic Object-Fitting
Object Review	The application providesfunctionality to control the reviewstate of objects. In case ofleaving the application withunreviewed semi-automaticallyor automatically created objects,a message is displayed.	The application providesfunctionality to control thereview state of objects. Incase of leaving theapplication with unreviewedsemi-automatically orautomatically createdobjects, a message isdisplayed.	Same as thepredicate.
Volumetric Report	It is possible to create a printablereport for an object in a platformindependent file format, givinginformation about the object'svolume, its diameter according tothe Macdonald criteria and itsresponse evaluation criteria(RECIST).If multiple objects are selectedand a volumetric report iscreated, it contains informationabout all objects.	It is possible to create aprintable report for anobject in a platformindependent file format,giving information about theobject's volume, itsdiameter according to theMacdonald criteria and itsresponse evaluation criteria(RECIST).If multiple objects areselected and a volumetricreport is created, it containsinformation about allobjects.	Same as thepredicate.

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Image /page/8/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized symbol on the left and the word "BRAINLAB" in capital letters on the right. The color of the logo is pink.

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Image /page/9/Picture/0 description: The image shows the word "BRAINLAB" in a bold, sans-serif font. To the left of the word is a stylized graphic that appears to be a symbol or logo. The color of both the text and the graphic is a bright pink.

Brainlab Elements BOLD MRI Mapping

Topic/ Feature	Secondary Predicate Device(iPlan (K113732))	Subject Device (BrainlabElements BOLD MRIMapping)	Comment
Indications for Use	iPlan's indications for use are theviewing, presentation, anddocumentation of medical	Brainlab Elements BOLDMRI Mapping provides toolsto analyze task based blood	Both devicescontain highlygeneric product

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Image /page/10/Picture/0 description: The image shows the word "BRAINLAB" in a pink sans-serif font. To the left of the word is a pink graphic that resembles a stylized caduceus. The graphic is composed of three curved lines that are stacked on top of each other.

	imaging, including differentmodules for image processing,image fusion, atlas assistedvisualization and segmentation,intraoperative functional planningwhere the output can be usede.g. with stereotactic imageguided surgery or other devicesfor further processing andvisualization.The device itself does not havespecific clinical indications.	oxygen level dependentdata (BOLD MRI Data) tovisualize the activationsignal.The device itself does nothave clinical indications	features that dealwith data handlingrather than specificindications for use.The BOLD MRIMapping Elementre-implementsexisting tools andfunctionality offeredby iPlan BOLD MRIMapping withregards tofunctional planning.
Preprocessing	- Brain Mask Filtering- Spatial Smoothing- Motion Correction(Optional)- Slice Time Correction(Optional)- Denoising (Low PassFiltering)	- Brain Mask Filtering- Spatial Smoothing- Motion Correction- Optionally use ofDistortion Correction fromBrainlab Elements ImageFusion- Only for task-basedanalysis: Denoising (LowPass Filtering)	The followingpreprocessing toolswere added:- Optionallyuse of DistortionCorrection fromBrainlab ElementsImage Fusion,These tools wereevaluated for safetyvia riskmanagementactivities carried outvalidated viaperformancevalidation testingand literaturereview.

4. Performance Data

Software Verification:

Software verification was performed, verifying the software requirements through integration tests, and unit tests. Incremental test strategies have been set up after verification of the first release candidate for changes with limited scope. In this case, an impact analysis of the modifications is performed and tests to be performed are identified and planned

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correspondingly. That means, not all tests have to be performed but only a subset, as some of the previous tests are not affected by the change and remain therefore valid. Software verification verifies all specifications, including SOUP items and cybersecurity. For newly added components, interoperability tests were carried out, in addition to the individual component verification.

Clinical Validation:

As a part of the design validation process, pre-clinical validation activities were carried out for the Subject Device pertaining to its indications for use.

The Clinical Validation activities concluded that the Subject Device:

Provides state of the art features for the purposes of pre-planning for Cranial, ENT, CMF Surgery and Radiotherapy Planning.
All applicable safety and performance requirements are fulfilled.
Device does not pose significant levels of risk and adequate risk mitigation measures are implemented.
Usability aspects have been considered during the development of the device and the device was found to be suitable for the user group stated.
Clinical data collected establishes the performance and safety of the Subject Device and that the clinical benefits outweigh any potential risks associated with the product.

5. Conclusion

Verification and validation activities carried out established that the set requirements were met and that the device performs as claimed.

The Subject Devices' comparison with the Predicate Devices establishes that they have similar functionality, intended use and technological characteristics. Therefore, we believe that the Subject Device can be considered substantially equivalent to the 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).