CereFlow™ V1.2 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.

CereFlow™ V1.2 provides visualization and automatic semi-quantification of Arterial Spin Labeling (ASL) data acquired from Magnetic Resonance Imaging (MRI) scanners at 1.5T and 3.0T.

CereFlow™ V1.2 is able to process single-delay and multi-delay ASL data to quantify multiple perfusion parameters (Cerebral Blood Flow/CBF, Arterial Transit Time/ATT), and exports the results of ASL image analysis as DICOM images and in a report.

Device Description

CereFlow™ V1.2 is a medical viewing, analysis and processing, Medical Image Management and Processing System software implemented in Java and Java tools, compliant with the DICOM standard and running on standard PC (Windows 10 64-bit). CereFlow™ V1.2 is intended for visualization and automatic semi-quantitative quantification of arterial spin labeling (ASL) data acquired from MRI scanners at 1.5T and 3.0T. CereFlow™ V1.2 is able to process single-delay and multi-delay ASL data to generate multiple perfusion parameters (Cerebral Blood Flow/CBF, Arterial Transit Time/ATT), and exports the results of ASL image analysis as DICOM images and in a report.

The software consists of three modules, namely the interface module, and the database module. The interface module is responsible for interacting with users and helping them to manage cases easily. The report module is responsible for processing raw DICOM images and calculating parameters to generate ATT/CBF images which can be exported as DICOM images and in a report. Image pre-processing includes sorting and checking files to ensure designated protocols are used, having a complete set of reference (MO) image and label/control images, and implementing motion correction. The calculation of CBF and ATT parameters is implemented using the standard one-compartment perfusion model recommended by the consensus ASL white paper and standard nonlinear iterative curve-fitting approach for multi-delay ASL data. For single-delay ASL data, CBF is calculated according to the standard one-compartment perfusion model recommended by the ASL white paper.

The database module is responsible for managing cases including storing, query and deleting case data. The software applies an arrange of quality control parameters to ensure the quality of acquired ASL data and processed results. These quality control parameters can also be exported as a report.

The entire workflow is processed locally, and the report module shall only allow raw ASL imaging data importing from DICOM CD-R only. CereFlow™ V1.2 is not interface with DICOM servers, MR scanners, or PACS over wired network. It is a standalone software application designed to run on a dedicated PC workstation.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for CereFlow™ V1.2, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative format for specific performance metrics like sensitivity, specificity, or agreement. Instead, it focuses on functional validation and comparison to a predicate device. The performance is reported in terms of successful completion of functionalities and accuracy validated against a reference.

Acceptance Criterion (Implicit)	Reported Device Performance
DICOM Images Importation	Verified
Case Management	Verified
Automatic Semi-quantitative Quantification	Verified
Multiple Perfusion Parameters Calculation (CBF, ATT)	Verified. The calculation of CBF and ATT parameters is implemented using the standard one-compartment perfusion model recommended by the consensus ASL white paper and standard non-linear iterative curve-fitting approach for multi-delay ASL data. For single-delay ASL data, CBF is calculated according to the standard one-compartment perfusion model.
Visualization of ASL Image	Verified
Report Generation	Verified
Digital Phantom Validation Study	Conducted
Instrumental Validation Studies	Conducted
Accuracy of Quantitative Perfusion Parameters (Multi-delay ASL)	Demonstrated through additional verification tests. Also, performance was compared to GE 3D ASL on ASL data acquired via GE scanner.
Conformance to Standards	ACR/NEMA DICOM Version 3.1, ISO 14971:2019, IEC 62304:2006/AMD 1:2015
Substantial Equivalence to Predicate Device (Olea Sphere V3.0)	Concluded based on similar intended use, technological characteristics, and performance, with differences not raising new safety/effectiveness issues.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "retrospective clinical studies were conducted to validate performance" but does not specify the sample size for these clinical studies.
Data Provenance: The document does not explicitly state the country of origin of the data. It refers to ASL data acquired from "commercial MRI scanners at 1.5T and 3.0T" and mentions comparing performance to GE 3D ASL using "ASL data acquired via GE scanner," but geographical origin is not provided. The studies were retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts used to establish ground truth for the test set.
It refers to the use of a "standard one-compartment perfusion model recommended by the consensus ASL white paper" for CBF and ATT calculations, implying that an established scientific consensus (rather than ad-hoc expert ground truth) was used as the reference standard for these quantifiable parameters.
The document does state that the software is "to be used by trained professionals including but not limited to physicians and medical technicians." This refers to the end-users of the device, not experts establishing ground truth for validation.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth, such as 2+1 or 3+1. Given the focus on quantifiable parameters based on established models and digital phantoms, a traditional expert adjudication process for image interpretation might not have been applicable in the same way it would be for diagnostic interpretation tasks.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study regarding human readers' improvement with AI vs. without AI assistance. The study focuses on the standalone performance and accuracy of the algorithm itself.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The document details "non-clinical testing including verification tests" and "retrospective clinical studies were conducted to validate performance of the CereFlow™ V1.2 meeting the acceptance criteria." This implies testing the algorithm's performance independent of human-in-the-loop interaction.
It also states, "Translational MRI, LLC intends to compare the performance (i.e. quantification accuracy of CBF maps) of CereFlow™ V1.2 to the performance of GE 3D ASL at each post-labeling delay using the ASL data acquired via GE scanner." This is a direct comparison of algorithmic output to a reference algorithm.

7. Type of Ground Truth Used

The ground truth for the quantifiable perfusion parameters (CBF, ATT) was established using:
- "Standard one-compartment perfusion model recommended by the consensus ASL white paper": This serves as a well-established, scientifically accepted reference for calculating these parameters from ASL data.
- Digital phantoms: Mentioned in the non-clinical testing. These typically have known, simulated ground truth values.
- Comparison to a reference device/algorithm (GE 3D ASL): The accuracy of CBF maps was compared to GE 3D ASL, implying that the output of this established algorithm served as a reference for comparison.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established, as it does not discuss the training process for the algorithm. It primarily focuses on the validation of the device's calculations against established models and reference systems.

Summary

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March 31, 2023

Translational MRI, LLC % Andrew Wu General Manager, Software Consultant Rook Quality Systems Taiwan Branch Office 802, No. 502, Sec 2, Ren'ai Road, Linkou District New Taipei City, 24 TAIWAN

Re: K211059

Trade/Device Name: CereFlow™ V1.2 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: February 15, 2023 Received: February 27, 2023

Dear Andrew Wu:

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

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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,

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) K211059

Device Name CereFlow™ V1.2

Indications for Use (Describe)

CereFlow™ V1.2 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelt" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images are acquired through DICOM compliant imaging devices and modalities.

CereFlow™ V1.2 provides visualization and automatic semi-quantification of Arterial Spin Labeling (ASL) data acquired from Magnetic Resonance Imaging (MRI) scanners at 1.5T and 3.0T.

CereFlow™ V1.2 is able to process single-delay and multi-delay ASL data to generate multiple perfusion parameters (Cerebral Blood Flow/CBF, Arterial Transit Time/ATT), and exports the results of ASL image analysis as DICOM images and in a report.

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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510(k) Summary

Date Prepared

Feb 13th, 2023

Manufacturer and 510(k) Owner

Translational MRI, LLC 3200 S Sepulveda Blvd Suite K30 Los Angeles, CA 90034

Official Contact:	Zhihai Ricky Xiang
Telephone	+1-530-760-9006
Email	zhihaixiang@transmri.com

Representative/Consultant

Andrew Wu, General Manager Principal Software Consultant
Rook Quality Systems Taiwan Branch
Office 802, No. 502, Sec 2, Ren'ai Road, Linkou District, New Taipei City, 244, R.O.C
Telephone:	+886-912-258980
Email:	andrew.wu@rookqs.com

Device Information

Trade/Proprietary Name	CereFlow™ V1.2
Classification Name	Medical image management and processing system
Regulation Number	21 CFR 892.2050
Product Code(s)	LLZ
Classification	Class II
Review Panel	Radiology Device
Use	Prescription

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Indications for Use

CereFlow™ V1.2 provides visualization and automatic semi-quantification of Arterial Spin Labeling (ASL) data acquired from Magnetic Resonance Imaging (MRI) scanners at 1.5T and 3.0T.

Device Description

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CereFlow™ V1.2 is for prescription use. Information provided by CereFlow™ V1.2 is not intended in any way to eliminate, replace, or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

Technological Characteristics

The CereFlow™ V1.2 is a software-only device that runs on a workstation computer that meets the minimum requirements.

The CereFlow™ V1.2 receives DICOM datasets acquired from MRI scanners at 1.5T and 3.0T and provides visualization and automatic semi-quantification of ASL data to the physicians. The user can import single-delay and multi-delay ASL data, and export the results of ASL image analysis as DICOM images and in a PDF report.

CereFlow™ V1.2 does not contact the patient, nor does it control any life sustaining devices. Information provided by the CereFlow™ V1.2 is not intended in any way to eliminate, replace, or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

Predicate Device Identification

The CereFlow™ V1.2 is substantially equivalent to the Olea Sphere V3.0 (K152602).

The CereFlow™ V1.2 has the same intended use and similar indications, technological characteristics, and principles of operation to the device cleared in K152602. The differences in technological characteristics between the subject device and the predicate device do not raise new issues of safety and effectiveness. Therefore, K152602 is listed as the predicate device for the CereFlow™ V1.2.

Equivalence to Predicate Device

Translational MRI, LLC submits the following information to demonstrate that the CereFlow™ V1.2 is substantially equivalent to the following legally marketed predicate device:

510(k) Number	Predicate DeviceName/Manufacturer	Primary Predicate
K152602	Olea Sphere V3.0	Yes

Translational MRI, LLC intends to use the reference device listed below for validation purpose. Translational MRI, LLC intends to compare the performance (i.e. quantification accuracy of CBF maps) of CereFlow™ V1.2 to the performance of GE 3D ASL at each post-labeling delay using the ASL data acquired via GE scanner.

510(k) Number	Predicate DeviceName/Manufacturer	Reference Device
K092925	3D ASL/GE Healthcare	Yes

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The subject device has the same intended use and similar technological characteristics (e.g. software for visualization and quantification of perfusion parameters of human brain acquired from MR scanners of high magnetic field strength (1.5T, 3.0T) using designated ASL protocol) to the device cleared in K152602. The differences in technological characteristics between the subject device and predicate device are explained below.

In the predicate device, the MR image acquired by protocols of conventional MRI, ASL, and Diffusion Weighted Imaging (DWI), whereas the subject device receives MR images only based on ASL protocol acquired from commercial MRI scanners at 1.5T and 3.0T. Hence, this technological difference does not raise new issues of safety and effectiveness as compared to the predicate device.
. In the predicate device, the image process algorithm can only process single-delay ASL data, whereas the subject device is able to process single-delay and multi-delay ASL data to generate multiple perfusion parameters (Cerebral Blood Flow/CBF, and Arterial Transit Time/ATT). Additional verification tests were carried out to demonstrate that the subject device yields accurate quantitative perfusion parameters using multi-delay ASL data. Hence, this technological difference does not raise new issues of safety and effectiveness as compared to the predicate device.
In the predicate device, the software outputs the perfusion map and allows user to customize the segmentation masks based on user defined areas, whereas the subject device only outputs multi-parametric maps of the whole brain region. Hence this technological difference does not raise new issues of safety and effectiveness as compared to the predicate device
. The predicate device can be operational on Windows and Linux, while the subject device can be operational on Windows only. Hence, this technological difference does not raise new issues of safety and effectiveness as compared to the predicate device.
. The predicate device can acquire images from multiple modalities or network using DICOM protocol, while the subject device can only import DICOM images via DICOM CD-R. Hence, this technological difference does not raise new issues of safety and effectiveness as compared to the predicate device.

The subject device does not have the following functionalities whereas the predicate has:

. Permeability post-processing (the calculation of parameters related to leakage of injected contrast material from intravascular to extracellular space)
. Relaxometry post-processing (the calculation of parameters related to the MR longitudinal and transversal relaxation time and rate)
. Metabolic post-processing (the calculation of parameters related to the fat signal fraction based on a MR technique using opposed-phase imaging)

Translational MRI, LLC believes that the CereFlow™ V1.2 described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to the legally marketed predicate device (K152602) based on the information summarized in the following Table 1 – Substantial Equivalence Summary.

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	Subject Device	Primary Predicate Device
Trade Name	CereFlow™ V1.2	Olea Sphere V3.0
Manufacturer	Translational MRI, LLC	Olea Medical
510(k) Number	K211059	K152602
Class	II	II
Device Classification Name	Medical image managementand processing system	Medical image managementand processing system
Regulation Number	892.2050	892.2050
Product Code	LLZ	LLZ
Indications for Use	CereFlow™ V1.2 is an imageprocessing software package tobe used by trained professionalsincluding but not limited tophysicians and medicaltechnicians. The software runson a standard "off-the-shelf"workstation and can be used toperform image viewing,processing, image collage andanalysis of medical images. Dataand images are acquiredthrough DICOM compliantimaging devices and modalities.CereFlow™ V1.2 providesvisualization and automaticsemi-quantitative quantificationof Arterial Spin Labeling (ASL)data acquired from MagneticResonance Imaging (MRI)scanners at 1.5T and 3.0T. It isrecommended the minimal SNRof perfusion images in whitematter should be equal to orlarger than 1.	Olea Sphere V3.0 is an imageprocessing software package tobe used by trained professionalsincluding but not limited tophysicians and medicaltechnicians. The software runson a standard "off-the-shelf"workstation and can be used toperform image viewing,processing, image collage andanalysis of medical images. Dataand images are acquiredthrough DICOM compliantimaging devices and modalities.Olea SphereV3.0 provides bothviewing and analysis capabilitiesof functional and dynamicimaging datasets acquired withMRI or other relevantmodalities, including a DiffusionWeighted Imaging (DWI) / FiberTracking Module and a DynamicAnalysis Module (e.g. dynamicexogenous or endogenouscontrast enhanced imaging datafor MRI and CT). The DWIModule is used to visualize localwater diffusion properties fromthe analysis of DiffusionWeighted MRI data. The FiberTracking feature utilizes thedirectional dependency of thediffusion to display the whitematter structure in the brain ormore generally the centralnervous system. The Dynamic
Physical Characteristics	Same
Computer	Same	Software package that operateson off-the-shelf workstationPC Compatible
	CereFlow™ V1.2 is able toprocess single-delay and multi-delay ASL data to generatemultiple perfusion parameters(Cerebral Blood Flow/CBF,Arterial Transit Time/ATT), andexports the results of ASL imageanalysis as DICOM images andin a report.	Analysis Module is used forvisualization and analysis ofdynamic imaging data, showingproperties of changes incontrast while repeatingacquisitions (e.g. over time withor without variable acquisitionparameters) where suchtechniques are useful ornecessary. This functionality isreferred to as:Perfusion Module – thecalculation of parametersrelated to tissue blood flow(perfusion) and tissue bloodvolume.Permeability Module – thecalculation of parametersrelated to leakage of injectedcontrast material fromintravascular to extracellularspace.Arterial Spin Labeling (ASL)Module - the calculation ofCerebral Blood Flow/CBFrelated to tissue flow based ona MR technique using the waterin arterial blood as endogenoustracer to evaluate the perfusion.Relaxometry Module - thecalculation of parametersrelated to the MR longitudinaland transversal relaxation timeand rate.Metabolic Module - thecalculation of parametersrelated to the fat signal fractionbased on a MR technique usingopposed-phase imaging.

Image Processing Location	Same	Onsite on the desktopcomputer as local application
DICOM Standard Compliance	Same	The software processes DICOMcompliant image data
Computer OS Compatibility	Windows	Windows, Linux
Modalities	Arterial Spin Labeling	Multi-modality
User Interface	Same	The software is designed for useon a radiology workstation.
Protocols	Same	Predefined or specificacquisition protocol settings
Image Processing AlgorithmDescription	Calculation of parametersrelated to blood flow based ona MR technique using the waterin arterial blood as endogenoustracer to evaluate the perfusion.Process single-delay and multi-delay ASL data to quantifymultiple perfusion parameters(Cerebral Blood Flow/CBF, andArterial Transit Time/ATT)	Calculation of parametersrelated to blood flow based ona MR technique using the waterin arterial blood as endogenoustracer to evaluate the perfusion.Process single-delay ASL dataand quantify Cerebral BloodFlow/CBF
Image Acquisition	Same	The acquisition remains thesame, i.e. the image processingcan be generated from multiplemodalities and with predefinedor specific acquisition protocolsettings.
Region of Interest	User cannot select region ofinterest.	User can customize thesegmentation masks based theirselected region of interest.

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Performance Data

The subject device is designed in conformance with:

ACR/NEMA Digital Imaging Communications in Medicine (DICOM) Version 3.1
ISO 14971:2019 Medical Devices Application of Risk Management to Medical Devices ●
IEC 62304:2006/AMD 1:2015 – Medical Device Software – Software Life-Cycle Processes

All specifications of the CereFlow™ V1.2 were verified by a number of tests before release. Non-clinical testing including verification tests on:

System-level, functional testing .
- O DICOM images importation
- O Case management
- O Automatic semi-quantitative quantification
- O Multiple perfusion parameters calculation

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Visualization of ASL image o
Report generation o
Digital phantom validation study
Instrumental validation studies ●

In addition, retrospective clinical studies were conducted to validate performance of the CereFlow™ V1.2 meeting the acceptance criteria.

Translational MRI, LLC believes that the aforementioned non-clinical testing demonstrates that the subject device is designed in such a way that, when used under the conditions and for the purposes intended, the safety and effectiveness, as well as the performance characteristic of the subject device is substantially equivalent to the predicate device.

Substantial Equivalence Conclusion

CereFlow™ V1.2 has the same intended use and performance characteristics as the predicate device. Based on the software verification performed, it can be concluded that the differences in technological characteristics between the CereFlow™ V1.2 and the predicate device do not raise different questions of safety and effectiveness under specified use conditions. The indications for use, technological characteristics, and performance characteristics for the CereFlow™ V1.2 are assessed to be substantially equivalent to the predicate device. There is no identified hazard that require additional benefit versus risk analysis in support of substantial equivalence.

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).