The AutoChamber software is an opportunistic AI-powered quantitative imaging tool that measures and reports cardiac chambers volumes comprising left atrium (LA), left ventricle (LV), right atrium (RA), right ventricle (RV), and left ventricular wall (LVW) from non-contrast chest CT scans including coronary artery calcium (CAC) scans and lung CT scans. AutoChamber is not intended to rule out the risk of a cardiovascular disease, and the results should not be used for any purpose other than to enable physicians to investigate patients that AutoChamber shows signs of enlarged heart (cardiomegaly), enlarged cardiac chambers, and left ventricular hypertrophy (LVH) whose conditions are otherwise missed by human eyes in non-contrast chest CT scans. AutoChamber similarly measures and reports LA, LV, RA, RV, and LVW in contrast-enhanced coronary CT angiography (CCTA) scans. Additionally, AutoChamber measures and reports cardiothoracic ratio (CTR) in both contrast and non-contrast CT scans where the entire thoracic cavity is in the axial field of view. AutoChamber quantitative imaging measurements are adjusted by body surface area (BSA) and are reported both in cubic centimeter volume (cc) and percentiles by gender using reference data from 5830 people who participated in the Multi-Ethnic Study of Atherosclerosis (MESA). AutoChamber should not be ordered as a standalone CT scan but instead should be used as an opportunistic add-on to existing and new CT scans of the chest, such as CAC and lung CT scans, as well as CCTA scans.

Using AutoChamber quantitative imaging measurements and their clinical evaluation, healthcare providers can investigate asymptomatic patients who are unaware of their risk of heart failure, atrial fibrillation, stroke and other life-threatening conditions associated with enlarged cardiac chambers, and LVH that may warrant additional risk-assessment or follow-up. AutoChamber quantitative imaging measurements are to be reviewed by radiologists or other medical professionals and should only be used by healthcare providers in conjunction with clinical evaluation.

Device Description

The AutoChamber Software is an opportunistic AI-powered quantitative imaging tool that provides an estimate of cardiac volume, cardiac chambers volumes and left ventricular (LV) mass from non-contrast chest CT scans as well as contrast-enhanced chest CT scans. In addition to cardiac chambers volume and LV mass, AutoChamber measures and reports cardiothoracic ratio (CTR).

AutoChamber Software reads a CT scan (in DICOM format) and extracts scan specific information like acquisition time, pixel size and scanner type. The AutoChamber Software uses an AI trained model to identify cardiac chambers in the field of view and measure the volume of each chamber including left atrium (LA), left ventricle (LV), right atrium (RA), right ventricle (RV), and LV wall (LVW). AutoChamber calculates the volume of each chamber as well as the corresponding total volume of all cardiac chambers and, if the field of view contains the entire width of the thoracic cavity in the axial view, it calculates and reports cardiothoracic ratio (CTR).

AutoChamber calculates the volume of each chamber based upon the volume of each pixel multiplied by the number of pixels in the region of interest per slice, multiplied by the number of slices included in each chamber's segmentation. The total volume per chamber is reported in cubic centimeters (CC). In addition to reporting the measured volume in CC per chamber report shows volumes adjusted by body surface area (BSA) and corresponding percentiles using reference data from 5830 people who participated in the Multi-Ethnic Study of Atherosclerosis (MESA). The default cut-off value for further investigations is the 75th percentile but it is optional and subject to provider's judgement.

AutoChamber does not provide a numerical individualized risk score/prediction or categorial assessment for whether an individual patient will develop cardiovascular disease over a specified period of their percentile(s).

AutoChamber is a post-processing quantitative imaging software that works on existing and new CT scans. The AutoChamber Software is a software module installed by trained personnel only. The AutoChamber Software is executed via a parent software which provides the necessary input and visualizes the output data. The software itself does not offer user controls or access. The user cannot change or edit the segmentation or results of the device. The user must accept or reject the region where the cardiac chamber volume measurement is done. If rejected, the user must retry with a new series of images or conduct an alternate method to measure cardiac chamber volume. The expert's review solely pertains to the region of interest being properly located.

Software passes if the healthcare provider sees the cardiac chamber volumes and left ventricular mass highlighted by AutoChamber are correctly placed on the cardiac region based upon expert knowledge. Software fails if the healthcare provider sees the cardiac chamber volumes and left ventricular mass highlighted by AutoChamber are incorrectly placed outside of the cardiac anatomy. Software fails if the healthcare provider sees that the quality of the CT scan is compromised by image artifacts, motion, or excessive noise.

AI/ML Overview

Based on the provided text, here's a description of the acceptance criteria and the study proving the device meets them:

Acceptance Criteria and Device Performance

The document does not explicitly state a table of quantitative acceptance criteria for the performance of the AutoChamber software (e.g., a specific mean absolute error for volume measurements or a target F1-score for segmentation). Instead, the software validation section states: "Software Verification and Validation testing was completed to demonstrate the safety and effectiveness of the device. Testing demonstrates the AutoChamber Software meets all its functional requirements and performance specifications."

The closest the document comes to defining acceptance criteria is in the "Principles of Ops" section, describing conditions for software pass/fail from a user's perspective:

Software passes if the healthcare provider sees the cardiac chamber volumes and left ventricular mass highlighted by AutoChamber are correctly placed on the cardiac region based upon expert knowledge.
Software fails if the healthcare provider sees the cardiac chamber volumes and left ventricular mass highlighted by AutoChamber are incorrectly placed outside of the cardiac anatomy.
Software fails if the healthcare provider sees that the quality of the CT scan is compromised by image artifacts, motion, or excessive noise.
The only user interaction is to accept or reject the region where the cardiac chamber volume measurement is done, with rejection leading to a retry or alternate method. "The expert's review solely pertains to the region of interest being properly located."

Given this, the qualitative acceptance criteria appear to be centered on the correct anatomical localization of the measured cardiac chambers by the AI, as confirmed by expert review.

Reported Device Performance:
The document does not provide specific metrics (e.g., mean absolute error, Dice coefficient, accuracy, sensitivity, specificity) for the performance of the AutoChamber software against its ground truth. It only states that "AutoChamber results were compared with measurements previously made by cardiac MRI" and other CT scans. Therefore, a table of acceptance criteria vs. reported device performance cannot be fully constructed from the provided text, as the specific performance outcomes are not detailed, nor are the quantitative acceptance thresholds.

Study Details:

The clinical validation of the AutoChamber software was based on retrospective analyses.

Sample sizes used for the test set and data provenance:
- Study 1: 5003 cases where AutoChamber results from non-contrast cardiac CT scans were compared with measurements previously made by cardiac MRI.
- Study 2: 1433 patients with paired non-contrast and contrast-enhanced cardiac CT scans.
- Study 3: 171 patients who underwent both ECG-gated cardiac CT scan and non-gated full chest lung scan.
- Study 4: 131 cases where AutoChamber results were compared directly with a Reference device (K060937).
- Data Provenance: The reference data for percentiles is from 5830 people who participated in the Multi-Ethnic Study of Atherosclerosis (MESA). The specific country of origin for the test set data (the 5003, 1433, 171, and 131 cases) is not explicitly stated, but MESA is a US-based study. All studies were retrospective analyses of existing databases.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies that "expert knowledge" is used to confirm the correct placement of cardiac chamber volumes and LV mass. However, it does not specify the number of experts, their qualifications (e.g., specific board certifications, years of experience), or the process by which they established ground truth for the volumes themselves (e.g., manual segmentation by experts, or if the "cardiac MRI" measurements served as the primary ground truth, and if so, how those were established).
Adjudication method for the test set:
- The document does not specify a formal adjudication method (e.g., 2+1, 3+1 consensus) for the expert review or the establishment of ground truth for the test set. It mentions "The expert's review solely pertains to the region of interest being properly located," implying individual expert qualitative assessment of the AI's output, rather than a multi-reader consensus process for establishing the ground truth values themselves.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study designed to measure how much human readers improve with AI vs. without AI assistance is not described. The document states that the AI measurements were compared against existing data (e.g., MRI measurements, other CT scans). The AI is presented as a "post-processing quantitative imaging software" that helps physicians investigate patients and is to be reviewed by radiologists or medical professionals. This implies an assistive role, but a formal MRMC study demonstrating enhancement of human reader performance is not mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the clinical validation involved comparing the AutoChamber software's measurements directly with other established measurement methods (cardiac MRI, other CT scans, and a reference device). This indicates a standalone performance evaluation of the algorithm's output against a reference. The "Principles of Ops" section states, "The user cannot change or edit the segmentation or results of the device. The user must accept or reject the region where the cardiac chamber volume measurement is done." This suggests the algorithm performs autonomously, and its output is then presented for acceptance/rejection based on anatomical placement.
The type of ground truth used:
- The primary ground truth appears to be measurements previously made by cardiac MRI in one key study (5003 cases), and measurements from other CT scans or a cleared reference device (K060937) in other studies. The document does not explicitly state that these "measurements" were derived from pathology or clinical outcomes data, but rather from other imaging modalities considered reference standards (MRI) or other devices. The qualitative "expert knowledge" mentioned for passing/failing the software seems to be about the anatomical correctness of the AI's segmentation/placement rather than the true quantitative values themselves.
The sample size for the training set:
- The sample size for the training set is not specified in the provided text. It only mentions that the AutoChamber Software uses an "AI trained model."
How the ground truth for the training set was established:
- The method for establishing ground truth for the training set is not specified in the provided text.

Summary

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October 10, 2024

HeartLung Corporation c/o Mark Scott Regulatory Consultant 2450 Holcombe Blvd Houston, Texas 77021

Re: K240786

Trade/Device Name: AutoChamber Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: March 7, 2024 Received: March 22, 2024

Dear Mark Scott:

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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Robert Oaks

Robert Ochs, Ph.D. Director 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) K240786

Device Name AutoChamber

Indications for Use (Describe)

The AutoChamber software is an opportunistic AI-powered quantitative imaging tool that measures and reports cardiac chambers volumes comprising left atrium (LA), left ventricle (LV), right ventricle (RV), and left ventricular wall (LVW) from non-contrast chest CT scans including coronary artery calcium (CAC) scans and lung CT scans. AutoChamber is not intended to rule out the risk of a cardiovascular disease, and the results should not be used for any purpose other than to enable physicians to investigate patients that AutoChamber shows signs of enlarged heart (cardiomegaly), enlarged cardiac chambers, and left ventricular hypertrophy (LVH) whose conditions are otherwise missed by human eyes in non-contrast CT scans. AutoChamber similarly measures and reports LA, LV, RA, RV, and LVW in contrast-enhanced coronary CT angiography (CCTA) scans. Additionally, AutoChamber measures and reports cardiothoracic ratio (CTR) in both contrast and non-contrast CT scans where the entire thoracic cavity is in the axial field of view. AutoChamber quantitative imaging measurements are adjusted by body surface area (BSA) and are reported both in cubic centimeter volume (cc) and percentiles by gender using reference data from 5830 people who participated in the Multi-Ethnic Study of Atherosclerosis (MESA). AutoChamber should not be ordered as a standalone CT scan but instead should be used as an opportunistic add-on to existing and new CT scans of the chest, such as CAC and lung CT scans, as well as CCTA scans.

Using AutoChamber quantitative imaging measurements and their clinical evaluation, healthcare providers can investigate asymptomatic patients who are unaware of their risk of heart failure, atrial fibrillation, stroke and other life-threatening conditions associated with enlarged heart, enlarged cardiac chambers, and LVH that may warrant additional riskassessment or follow-up. AutoChamber quantitative imaging measurements are to be reviewed by radiologists or other medical professionals and should only be used by healthcare providers in conjunction with clinical evaluation.

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/4/Picture/0 description: The image is a logo for "HeartLung". The logo is a blue square with rounded corners. Inside the square is a stylized image of a human torso with a red heart in the center and a blue head at the top. Below the heart are three horizontal lines representing the lungs. The text "HeartLung" is in red at the bottom of the image.

510(K) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92:

1. Submitter

HeartLung Corporation 1124 W Carson St. The Lundquist Institute, MRL Building, Floor 3 Torrance, CA 90502 Tel: (650) 448-8089 Contact: Dr. Morteza Naghavi Date Prepared: September 20, 2023

2. Device

Subject Device: Automated Cardiac Chambers Volumetry Software Trade Name: AutoChamber Common Name: AutoChamber Classification: Class II, 21 CFR 892.2050

Product Code: QIH 510(k) #: K240786

3. Predicate Device

Manufacturer: Imbio (Minneapolis, MN), LLC Trade Name: Imbio RV/LV Software Predicate 510(k): K203256

4. Reference Device

Manufacturer: Philips Medical Systems, (Cleveland), Inc. Trade Name: Philips Comprehensive Cardiac Analysis (CCA) Plaque Assessment Tool Reference 510(k): K092747

5. Device Description

General Description

AutoChamber™ is a trademark of the HeartLung Corporation. THIS DOCUMENT IS THE PROPERTY OF HEARTLUNG CORPORATION. © HEARTLUNG CORPORATION. ALL RIGHTS RESERVED.	Pg. 005-1 of 6
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Intended Patient Population

Patients who underwent a chest CT scan.

Principles of Ops

Conditions of Use:

AutoChamber™ is a trademark of the HeartLung Corporation. THIS DOCUMENT IS THEPROPERTY OF HEARTLUNG CORPORATION.© HEARTLUNG CORPORATION. ALL RIGHTS RESERVED.	Pg. 005-2 of 6
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Image /page/6/Picture/0 description: The image is a logo for HeartLung. The logo features a stylized human torso with a heart and lungs. The heart is pink and in the shape of a heart. The lungs are blue and are on either side of the heart. The torso is blue and is outlined in white. The text "HeartLung" is below the torso in red.

The AutoChamber Software is an AI-powered post-processing software module that works on non-contrast and contrast-enhanced chest CT scans.

6. Intended Use

Comparison of Technological Characteristics & Intended Use to Predicate Device

The table below provides a summary of the technological characteristics of the AutoChamber Software in comparison to the predicate device. The indications for use for the predicate device are similar to the indications for the use of the AutoChamber Software. There are no major technological differences between the two systems that raise new issues of safety and/or effectiveness. Thus, we submit the FDA should determine AutoChamber Software is substantially equivalent to the predicate and reference devices.

AutoChamber™ is a trademark of the HeartLung Corporation. THIS DOCUMENT IS THEPROPERTY OF HEARTLUNG CORPORATION.© HEARTLUNG CORPORATION. ALL RIGHTS RESERVED.	Pg. 005-3 of 6
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Image /page/7/Picture/0 description: The image is a logo for HeartLung. The logo features a stylized human torso in blue, with a pink heart in the chest area and three horizontal lines representing the lungs. The text "HeartLung" is written in red below the torso.

Feature	Subject DeviceAutoChamber SoftwareK240786	Predicate Device: ImbioRV/LVK203256	Reference Device: PhilipsComprehensive CardiacAnalysis (CCA) K092747
Indication forUse/IntendedUse	Use an artificialintelligence algorithm toidentify the locationand measure the volume ofcardiac chambers.	Use an artificial intelligencealgorithm to identify thelocation and measurementsof the cardiac ventricles.	Analyzing cardiac CT dataand measuring cardiacchamber sizes and coronaryplaque analysis.
Modality	CT scan images (DICOM)	CT scan images (DICOM)	CT scan images (DICOM)
Body Part	Heart / Chest	Heart / Chest	Heart
Automaticdefinition ofROIs	Yes, Deep Learning	Yes, Deep Learning	Yes, endoluminal andepiluminal segmentation
Deviceprovidesvolume in CC	Yes	Yes	Yes
User	Healthcare Provider	HealthcareProvider	Healthcare Provider
OperatingSystem	Linux	Windows	Windows
Retrospectivemeasurementsfrom CTscans.	CT scan images can beselected and inputted to thesoftware	CT scan images can beselected and inputted to thesoftware	CT scan images can beselected and inputted to thesoftware
Automation
	Software automaticallyidentifies cardiac chambers,estimates and reports thevolume of each chamber	Software automaticallyidentifies cardiac left andright ventricles and reportsRV/LV ratio	Software automaticallyidentifies cardiac chambers,estimates the volumes andreports RV/LV ratio

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Image /page/8/Picture/0 description: The image is a logo for a company called HeartLung. The logo features a stylized human figure with a heart in the chest area and lungs on either side of the heart. The heart is pink, and the lungs are blue. The text "HeartLung" is written in red and blue below the figure.

7. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Sterilization & Shelf-Life Testing

Not applicable for this software as a medical device.

Biocompatibility Testing

Not applicable for this software as a medical device.

Electrical Safety and Electromagnetic Compatibility (EMC)

Not applicable for this software as a medical device.

Software Verification and Validation Testing

Software Verification and Validation testing was completed to demonstrate the safety and effectiveness of the device. Testing demonstrates the AutoChamber Software meets all its functional requirements and performance specifications.

Mechanical and Acoustic Testing

Not applicable for this software as a medical device.

Animal Study

Animal performance testing was not required to demonstrate safety and effectiveness of the device.

Clinical Studies

Prospective clinical studies were not required to demonstrate the safety and effectiveness of the device. Instead, clinical validation is based upon retrospective analyses of AutoChamber software measurements in existing prospective studies databases were carried out. In one study AutoChamber results were compared with measurements previously made by cardiac MRI in 5003 cases who underwent both non-contrast cardiac CT scan and cardiac MRI. Furthermore, AutoChamber results were compared in 1433 patients with paired non-

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Image /page/9/Picture/0 description: The image is a logo for "HeartLung". The logo features a stylized representation of the human torso, with the lungs and heart prominently displayed. The heart is colored pink, while the rest of the torso and lungs are in shades of blue. The text "HeartLung" is written in a stylized font below the image.

contrast and contrast-enhanced cardiac CT scans. In yet another study, AutoChamber results were compared in 171 patients who underwent both ECG-gated cardiac CT scan and non-gated full chest lung scan. Additionally, clinical performance was established based on direct comparison of AutoChamber results with Reference device (K060937) in 131 cases who underwent both measurements.

8. Conclusions

The body of testing summarized above indicates that the AutoChamber Software performs as intended and supports a determination of substantially equivalence to the predicate device. The testing above demonstrates that the AutoChamber Software is as safe and effective as the predicate device. No new safety or effectiveness issues are raised by the AutoChamber Software.

	AutoChamber™ is a trademark of the HeartLung Corporation. THIS DOCUMENT IS THEPROPERTY OF HEARTLUNG CORPORATION.© HEARTLUNG CORPORATION. ALL RIGHTS RESERVED.	Pg. 005-6 of 6
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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).