The nCommand Lite system allows remote access for viewing/review of images as well as the ability to remotely provide real-time quidance to the licensed technologist operating a compatible MRI, CT, and PET-CT scanner. This access must be granted by the local licensed technologist operating the system. The remote access is only available for systems supporting remote connectivity capability. Images reviewed remotely are not for diagnostic use.

Device Description

The nCommand Lite system is a SaMD (Software as Medical Device) that is customer-facing and provides remote access through a web application for viewing images as well as the ability to remotely provide real-time guidance to the near-patient licensed technologist (local users) operating the medical imaging devices in the context of training, procedure assessment, for MN, CT, and PET-CT scanner.

Remote users are licensed technologists and are able to access an imaging medical device from a computer that meets the minimum required specifications anywhere, using a secure software connection that streams video and mouse access. This allows remote users to assist local users with both remote and resoonsibilities being subject to local requlations where the imaging occurs. This access must by the local user using the system, and it can also be revoled at any time by the local user, thus allowing him/her to maintain complete control of the session at all times. Also, each remote session is controlled via a secure credential that is managed by the local user. Connections to a medical device are limited to one remote session at a time to maintain strict control over who is remotely interacting with the system. Images reviewed remotely are not for diagnostic use. n Command Lite is an IT hardware and software-based installation solution that supports multisesson, allowing remote technologists to view multiple medical imaging devices as needed. However, access is restricted to one medical imaging device at any given time, as only one keyboard and one mouse are provided.

Scanners that are compatible with nCommand Lite system comply with a common protocol, allowing for scanning parameter management and remote scanning.

AI/ML Overview

The provided text describes the nCommand Lite System, a Software as a Medical Device (SaMD) that facilitates remote access for viewing medical images and providing real-time guidance to technologists operating MRI, CT, and PET-CT scanners.

However, the submission primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and non-clinical testing, rather than presenting performance metrics against specific acceptance criteria for diagnostic accuracy or clinical outcomes. The device explicitly states that "Images reviewed remotely are not for diagnostic use." This significantly changes the type of acceptance criteria and supporting studies expected.

Therefore, the response will focus on the acceptance criteria implied by the non-clinical tests and the general safety and effectiveness claims.

Acceptance Criteria and Study Details for nCommand Lite System

Given that the nCommand Lite system is explicitly "not for diagnostic use" and assists in providing "real-time guidance" during scanner operation, the acceptance criteria are focused on safety, functionality, usability, and cybersecurity rather than diagnostic performance metrics (e.g., sensitivity, specificity, AUC). The provided submission details the non-clinical tests performed to demonstrate substantial equivalence to predicate devices in these areas.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from submission)	Reported Device Performance (Inferred from submission)
Software Functionality & Reliability	The software operates as intended, reliably facilitating remote access, image viewing, and real-time guidance.	Non-clinical software testing was performed following FDA guidance (e.g., "Content of Premarket Submissions for Device Software Functions," "General Principles of Software Validation Guidance") and recognized standards (e.g., IEC 62304, ANSI/AAMI SW91). The conclusion is that the device is "as safe, as effective, and performs equivalently" to predicates.
Cybersecurity	The system is secure against unauthorized access, data breaches, and other cyber threats.	Cybersecurity testing was performed following FDA guidance ("Cybersecurity in Medical Devices") and recognized standards (e.g., NIST Cybersecurity Framework, IEC 81001-5-1, ANS/ISA 62443-4-1, AAM TIR57). The conclusion states the device is "as safe, as effective, and performs equivalently" to predicates.
Usability & Human Factors	The system is safe and effective for its intended users (remote and local technologists) in its intended use environment, without causing undue use errors.	Usability engineering/human factors testing was performed following FDA guidance ("Applying Human Factors and Usability Engineering to Medical Devices") and recognized standards (e.g., IEC 62366-1). The conclusion states the device is "as safe, as effective, and performs equivalently" to predicates.
Electrical Safety & Electromagnetic Compatibility (EMC)	The device meets electrical safety and EMC requirements to ensure safe operation without interfering with other equipment.	Adherence to recognized standards: IEC 60601-1 (medical electrical equipment basic safety and essential performance) and IEC 60601-1-2 (collateral standard for electromagnetic disturbances). The conclusion states the device is "as safe, as effective, and performs equivalently" to predicates.
Risk Management	All identified risks associated with the device's use are appropriately managed and mitigated.	Application of risk management processes following ISO 14971:2019. The conclusion states the device is "as safe, as effective, and performs equivalently" to predicates.

2. Sample Size for Test Set and Data Provenance

The submission primarily discusses non-clinical testing (software, cybersecurity, usability, electrical safety) rather than clinical studies with patient data. Therefore, there isn't a "test set" in the traditional sense of medical images or patient cases to determine diagnostic accuracy.

Sample Size: Not applicable in the context of patient data. The "test set" would refer to the scenarios, use cases, and testing environments used for the non-clinical evaluations. Specific numbers for these scenarios are not provided in the summary.
Data Provenance: Not applicable as no patient data or images were used to demonstrate performance against diagnostic acceptance criteria. The provenance relates to the simulated environments, test data, and user interactions during the non-clinical tests.

3. Number of Experts and Qualifications for Ground Truth

Given the non-diagnostic, assistance-based nature of the device and the focus on non-clinical testing, the concept of "ground truth" established by medical experts (e.g., radiologists) for a test set is not directly relevant in the way it would be for a diagnostic AI device.

Number of Experts: Not specified or applicable for a ground truth derived from clinical diagnostic labels.
Qualifications of Experts: For usability testing and software validation, "experts" would typically refer to software engineers, human factors engineers, cybersecurity specialists, and potentially experienced medical technologists who participated in user acceptance testing or usability evaluations. Their specific qualifications are not detailed in the provided summary.

4. Adjudication Method for Test Set

Not applicable, as there is no mention of a test set requiring adjudication by medical experts to establish ground truth for diagnostic purposes. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements in expert opinions for diagnostic labels.

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

Was an MRMC study done? No, an MRMC comparative effectiveness study was not performed.
Effect size of human readers with AI vs. without AI assistance: Not applicable, as this device is not designed to provide AI assistance for diagnostic interpretation of medical images. Its purpose is to provide remote guidance and access to operating medical imaging equipment.

6. Standalone Performance (Algorithm only without Human-in-the-loop)

Was a standalone performance study done? Yes, in a sense, the non-clinical testing (software, cybersecurity, compliance with standards) evaluates the device's functionality and safety characteristics in a standalone manner, separate from human operation during actual clinical scenarios. For example, software unit tests, integration tests, and system tests would evaluate the algorithm's performance on its own, ensuring it can connect, stream video, and process input/output as designed. However, this is not a clinical standalone performance in terms of diagnostic accuracy.

7. Type of Ground Truth Used

The concept of "ground truth" in this submission relates to:

Functional Specifications: The ground truth for software testing is that the software performs its specified functions correctly and reliably.
Cybersecurity Standards: The ground truth for cybersecurity is adherence to established security protocols and standards.
Usability Requirements: The ground truth for usability is that the device can be used effectively and safely by its intended users.
Regulatory Standards: The ground truth is compliance with the recognized electrical safety and EMC standards.

There is no mention of "expert consensus, pathology, or outcomes data" being used as ground truth for a clinical assessment of the device, as its intended use is not diagnostic.

8. Sample Size for the Training Set

Not applicable. The nCommand Lite system is a software device that provides remote access and guidance. It is not described as an AI/ML model that requires a "training set" of medical images or other data to learn and make predictions or classifications. Its functionality is based on established software engineering principles and protocols for remote connectivity.

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

Not applicable, as there is no training set for an AI/ML model.

Summary

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March 18, 2024

Image /page/0/Picture/1 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.

Ionic Health % Jay Mansour Industry Consultant- The FDA Group The FDA Group, LLC 290 Turnpike Road Suite 200 Westborough, Massachusetts 01581

Re: K233660

Trade/Device Name: nCommand Lite System Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ, JAK, LNH, KPS Dated: November 13, 2023 Received: November 15, 2023

Dear Jay Mansour:

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 (the 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/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.

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).

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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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 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.

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-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. Gabriela M. Digitally signed by Gabriela M. Rodal -S Rodal -S Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

for

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K233660

Device Name

nCommand Lite System

Indications for Use (Describe)

The nCommand Lite system allows remote access for viewing/review of images as well as the ability to remotely provide real-time quidance to the licensed technologist operatible MRI, CT, and PET-CT scanner. This access must be granted by the local licensed technologist operating the system. The remote access is only available for systems supporting remote connectivity capability. Images reviewed remotely are not for diagnostic use.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Prepared on: 2023-11-17

Contact Details

21 CFR 807.92(a)(1)

Applicant Name	IONIC HEALTH
Applicant Address	Estrada Dr. Altino Bondensan, 500, Sala 1103 Eugênio de Melo SãoJosé dos Campos/SP SJ 12247-016 Brazil
Applicant Contact Telephone	55-12-3600-0181
Applicant Contact	Mr. José Leovigildo de Melo Coelho Filho
Applicant Contact Email	jlcoelho@ionic.health
Correspondent Name	The FDA Group, LLC
Correspondent Address	290 Turnpike Road Suite 200 Westborough MA 01581 United States
Correspondent Contact Telephone	6789088180
Correspondent Contact	Mr. Jay Mansour
Correspondent Contact Email	jmansour@the-fda-group.com
Device Name	21 CFR 807.92(a)(2)
Device Trade Name	nCommand Lite System
Common Name	System, Image Processing, Radiological
Classification Name	Medical image management and processing system
Regulation Number	892.2050
Product Code	LLZ (primary) ; Secondary Product Codes: LNH, JAK,KPS)
Legally Marketed Predicate Devices21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K150193	Customer Remote Console (CRC)	LLZ
K052423	MAGNETOM Systems with syngo Expert-i option	LNH
K061449	Syngo Expert-i	JAK
Device Description Summary		21 CFR 807.92(a)(4)

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CT scanner.

Scanners that are compatible with nCommand Lite system comply with a common protocol, allowing for scanning parameter management and remote scanning.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

The nCommand Lite system allows remote access for viewing/review of images as well as the ability to remotely provide real-time guidance to the licensed technologist operating a compatible

MRI, CT, and PET-CT scanner. This access must be granted by the local licensed technologist operating the system. The remote access is only available for systems supporting remote connectivity capability. Images reviewed remotely are not for diagnostic use.

Indications for Use Comparison

21 CFR 807.92(a)(5)

The rationale below includes (1) a general descriptions that the device will mitigate, including a description of the patient population for which the device is intended.

It also includes an explanation as to (2a) why the differences in the indications for use with predicate devices are not critical to the intended use of the device, (2b) why these differences do not constitute a new intended use of the device, and (2c) why these differences do not affect the safety and effectiveness of the device when used as labeled. Paragraphs (1) and (2) below cover the above. (1) General description of the conditions and patient population of the device:

The nCommand Lite system is a SaMD (Software as Medical Device) that is customer-facing and provides remote access through a web application for viewing images as well as the ability to remotely provide real-time quidance to the near-patient licensed technologist (local users) operating the medical imaging devices in the context of training, procedure assessment, for MRI, CT, and PET-CT scanner.

Remote users are licensed technologists and are able to access an imaging medical device from a computer that meets the minimum required specifications anywhere, using a secure software connection that streams video and mouse access. This allows remote users to assist local users, with both remote and responsibilities being subject to local regulations where the imaging occurs. This access must by the local user using the system, and it can also be revoled at any time by the local user, thus allowing him/her to maintain complete control of the session at all times. Also, each remote session is controlled via a secure credential that is managed by the local user. Connections to a medical device are limited to one remote session at a time to maintain strict control over who is remotely interacting with the system. Images reviewed remotely are not for diagnostic use. nCommand Lite is an IT hardware and software-based installation solution that supports multisession, allowing remote technologists to view multiple medical imaging devices as needed. However, access is restricted to one medical imaging device at any given time, as only one keyboard and one mouse are provided.

Scanners that are compatible with nCommand Lite system comply with a common protocol, allowing for scanning parameter management and remote scanning.

(2) The intended use of the subject device and the primary predicate device [Customer Remote Console (CRC)] are identical. The indications for use of the subject device and the primary predicate device are also identical, except for the generalization from "GE Healthcare medical imaging devices" to "compatible MRI, CT, and PET-CT scanner". This generalization is achieved via the use of eKVM software and the hardware connectivity, all tested and validated.

The intended use of the subject device and the second predicate device [MAGNETOM Systems with syngo Expert-i option] are identical in intent, although the wording somewhat differs. Such differences do not change the same main purpose. Similarly, the indications for use of the second predicate device are also identical, in that both allow for a remote technologist to assist a local technologist, except for the generalization from MRI scanners manufactured by Siemens Medical Solutions, to "compatible MRI, CT, and PET-CT scanner". This generalization is achieved via the use of eKVM software connectivity, all tested and validated.

The intended use of the subject device and the third predicate device [Syngo Expert-i] are identical in intent, although the wording somewhat differs. Such differences do not chan both achieve the same main purpose. Similarly, the indications for use of the subject device and the third predicate device are also identical, in that both allow for a remote technologist to assist a local technologist, except for the generalization from Syngo CT manufactured by Siemens Medical Solutions, Inc. USA, to "compatible MRI, CT, and PET-CT scanner". This generalization is achieved via the use of eKVM software connectivity, all tested and validated.

The intended use and indications for use of the subject device [Precision DL] are different, and this

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device is rather used as REFERENCE device. This reference device is included as an added justification for the use of product code KPS to the subject device.

Technological Comparison

21 CFR 807.92(a)(6)

The subject device has different technological characteristics from the predicate device(s), for which a summary [of how the technological characteristics of the device compare to predicate devices] is detailed below.
The predicate devices are K150193 (primary), K052423 (second), K061449 (third) and K223212 (fourth/reference).
The subject device and all predicate devices have the following technological characteristics in common:
1- Customer Facing User Interface (UI).	2- Do not use Bluetooth or Wireless.
3- The use of Ethernet Wire Connection.	4- Software solution.
5- Not for Diagnostic Purpose
Excluding the fourth/reference predicate device, the subject device and predicate devices (primary, second and third) have the following technological characteristics in common:
1- Remote Access for viewing/reviewing images.
2- Provide real-time training to the licensed local technologist operating the scanner.
3- Access is granted to the remote technologist by the local technologist.
Remote Technologist works under the supervision of the local technologist, who can revoke the access permission of the remote technologist at any time.
4- Only one remote access per machine at any given time.
5- Parameter Management.	6- No Image Manipulation.
Excluding the primary predicate device and the fourth/reference device, the subject device and the predicate devices (i.e., second and third) have the following technological characteristics in common:
1- Remote Scanning
2- Provide real-time guidance to the licensed local technologist operating the scanner. This guidance includes procedure assessment, and scanning parameter management.
3- Ability of the remote technologist to open multiple sessions concurrently.
4- No Video Conferencing.	5- Chat Functionality.
The subject device and the primary predicate device have the following technological characteristics in common:
1- Web Browser Application.
The subject device has the following technological characteristics that are not in common with ANY of the 4 predicate devices:
1- Connected machines are MRI, CT, and PET-CT, while:
a. Primary predicate device connects only with GEHC imaging* medical device [ *This includes MRI, CT, and PET-CT]
b. The second predicate device connects only with MRI machines from Siemens Medical Solutions (MAGNETOM Systems with syngo Expert-i option).
c. The third predicate device connects only with CT machines from Siemens Medical Solutions, Inc. USA.
d. The fourth/reference device connects only with PET-CT machines from GE Healthcare.
2- Connected devices are not machine brand specific, while:
a. Primary predicate device connects only with GEHC imaging* medical device [ *This includes MRI, CT, and PET-CT]
b. The second predicate device connects only with MRI machines from Siemens Medical Solutions (MAGNETOM Systems with syngo Expert-i option).
c. The third predicate device connects only with CT machines from Siemens Medical Solutions, Inc. USA.
d. The fourth/reference device connects only with PET-CT machines from GE Healthcare.
3- Recognized standards are different, as justified elsewhere in detail. Although technological characteristics are in common with some or all of the predicate devices, the underlaying architectural solution of the subject device is different, forcing a different set of recognized standards to apply to it.
Non-Clinical and/or Clinical Tests Summary & Conclusions	21 CFR 807.92(b)
Nonclinical tests include (1) software testing, (2) cybersecurity testing and (3) usability engineering / human factors testing.
The FDA guidance documents that were followed are:
1- Content of Premarket Submissions for Device Software Functions. Guidance for Industry and Food and Drug Administration Staff. JUNE 2023
2- Software as a Medical Device (SAMD): Clinical Evaluation Guidance for Industry and Food and Drug Administration Staff. DECEMBER 2017

2017

3- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. Guidance for Industry andFood and Drug Administration Staff. Document issued on September 27, 2023

4- General Principles of Software Validation Guidance for Industry and FDA Staff. JANUARY 2002

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5- Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff. FEBRUARY 2016

The recognized standards that were followed are:

1- ISO 14971:2019 - Medical devices - Application of risk management to medical devices. Recognition number: 5-125

2- IEC 62304:2006/Amd 1:2015 - Medical device software - Software life cycle processes - Amendment 1. Recognition number: 13-79

3- ANSI/AAMI SW91:2018 - Classification Of Defects In Health Software. Recognition number:13-105

4- NIST Cybersecurity Framework - Version: 1.1, Date April 16, 2018. Recognition number: 13-118

5- Medical Device and Health IT Joint Security (JSP) - Jan 2019 IEC 81001-5-1:2021. Recognition number: 13-122

6- ANS/ISA 62443-4-1 Version: 2018, Date: February 2018 - Security for industrial automation and control systems Part 4-1. Recognition number: 13-119

7- AAM TIR57 Version: 2016, Date:2016 - Principles for medical device security - Risk Management. Recognition number: 13-83

8- IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical devices - Part 1: Application of usability engineering to medical devices. Recognition number: 5-129

9- IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences #1 and #2 in the Relevant FDA Guidance and Supportive Publication section below. Recognition number: 19-49

10 - IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Electromagnetic disturbances - Requirements and tests. Recognition number: 19-36

The conclusion drawn from the non-clinical tests device in this 510(k) submission, nCommand Lite System, is as safe, as effective, and performs equivalently to the legally marketed predicate devices.

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).