(88 days)
Philips IntelliSpace Portal Platform is a software medical device that allows multiple users clinical applications from compatible computers on a network.
The system allows networking, selection, processing and filming of multimodality DICOM images.
This software is for use with off-the-shelf PC computer technology that meets defined minimum specifications .
Philips IntelliSpace Portal Platform is intended to be used by trained professionals, including but not limited to physicians and medical technicians.
This medical device is not to be used for mammography.
The device is not intended for diagnosis of lossy compressed images.
Philips IntelliSpace Portal Platform is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. This software is for use with offthe-shelf PC computer technology that meets defined minimum specifications.
The IntelliSpace Portal Platform communicates with imaging systems of different modalities using the DICOM-3 standard.
Here's an analysis of the provided text regarding the acceptance criteria and study for the IntelliSpace Portal Platform (K162025):
The submitted document is a 510(k) Premarket Notification for the Philips IntelliSpace Portal Platform. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device (GE AW Server K081985).
Important Note: The document focuses on demonstrating substantial equivalence for a Picture Archiving and Communications System (PACS) and related functionalities. Unlike AI/ML-driven diagnostic devices, the information provided here does not detail performance metrics like sensitivity, specificity, or AUC against a specific clinical condition using a test set of images with established ground truth from a clinical study. Instead, the acceptance criteria and "study" refer to engineering and functional verification and validation testing to ensure the software performs as intended and safely, consistent with a PACS system.
Here's the breakdown based on your requested information:
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A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria or reported performance results in the classical sense (e.g., sensitivity, specificity, accuracy percentages) because it's for a PACS platform, not a diagnostic AI algorithm for a specific clinical task.
Instead, the "acceptance criteria" for a PACS platform primarily relate to its functional performance, compliance with standards, and safety. The reported "performance" is a successful demonstration of these aspects.
Acceptance Criteria (Inferred from regulatory requirements and description) Reported Device Performance (as stated in the submission) Compliance with ISO 14971 (Risk Management) Demonstrated compliance with ISO 14971. (p. 9) Compliance with IEC 62304 (Medical Device Software Lifecycle Processes) Demonstrated compliance with IEC 623304. (p. 9) Compliance with NEMA-PS 3.1-PS 3.20 (DICOM Standard) Demonstrated compliance with NEMA-PS 3.1-PS 3.20 (DICOM). (p. 9) Compliance with FDA Guidance for Content of Premarket Submissions for Software Contained in Medical Devices Demonstrated compliance with relevant FDA guidance document. (p. 9) Meeting defined functionality requirements and performance claims (e.g., networking, selection, processing, filming of multimodality DICOM images, multi-user access, various viewing/manipulation tools as listed in comparison tables) Verification and Validation tests performed to address intended use, technological characteristics, requirement specifications, and risk management results. Tests demonstrated the system meets all defined functionality requirements and performance claims. (p. 9) Safety and Effectiveness equivalent to predicate device Demonstrated substantial equivalence in terms of safety and effectiveness, confirming no new safety or effectiveness concerns. (p. 9, 10) -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This type of information is not provided in this document. Since the submission is for a PACS platform and not a diagnostic AI algorithm, there is no mention of a "test set" of clinical cases or patient data in the context of diagnostic performance evaluation. The "testing" refers to software verification and validation, which would involve testing functionalities rather than analyzing a dataset of medical images.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. As explained above, there is no "test set" of clinical cases with ground truth established by medical experts for diagnostic performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. There is no clinical "test set" requiring adjudication for diagnostic performance.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a PACS platform, not an AI-assisted diagnostic tool designed to improve human reader performance for a specific clinical task. The submission explicitly states: "The subject of this premarket submission, ISPP does not require clinical studies to support equivalence." (p. 9).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study (in the context of an AI algorithm performing a diagnostic task) was not done. This device is a software platform for image management and processing, intended for use by trained professionals (humans-in-the-loop) for visualization and administrative functions.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided. There is no ground truth data in the context of diagnostic accuracy for this PACS platform submission. The "ground truth" for its functionality would be defined by its requirement specifications, and testing would verify if those specifications are met.
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The sample size for the training set
This information is not applicable/not provided. This device is a PACS platform, not an AI/ML algorithm that requires a "training set" of data in the machine learning sense. The software development process involves design and implementation, followed by verification and validation, but not training on a dataset of images to learn a specific task.
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How the ground truth for the training set was established
This information is not applicable/not provided. As there is no "training set," there is no ground truth establishment for it.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V. C/O MARK JOB RESPONSIBLE THIRD PARTY OFFICIAL 1394 25TH STREET, NW BUFFALO MN 55313
Re: K162025
Trade/Device Name: IntelliSpace Portal Platform Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 7, 2016 Received: October 11, 2016
Dear Mr. Job:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
October 18, 2016
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162025
Device Name IntelliSpace Portal Platform
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
Philips IntelliSpace Portal Platform is a software medical device that allows multiple users clinical applications from compatible computers on a network.
The system allows networking, selection, processing and filming of multimodality DICOM images.
This software is for use with off-the-shelf PC computer technology that meets defined minimum specifications .
Philips IntelliSpace Portal Platform is intended to be used by trained professionals, including but not limited to physicians and medical technicians.
This medical device is not to be used for mammography.
The device is not intended for diagnosis of lossy compressed images.
| 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
IntelliSpace Portal Platform
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Date prepared: | September 18, 2016 |
|---|---|
| ---------------- | -------------------- |
I. Submitter's name and address
| Establishment name: | Philips Medical Systems Nederland B.V. |
|---|---|
| Establishment address: | Veenpluis 4-65684 PC BestThe Netherlands |
| Establishmentregistration: | 3003768277 |
| Contact person: | Ilana Ben MosheRegulatory Affairs ExpertPhone: +972 525233496Email: Ilana. Ben-Moshe@philips.com |
II. Device information
| Trade name: | IntelliSpace Portal Platform |
|---|---|
| Common name: | Image and Information Management Platform |
| Classification name: | Picture Archiving and Communications System (21 CFR 892.2050,Product Code LLZ) |
| Device classification: | Class II |
III. Predicate device information
| Trade name: | AW Server |
|---|---|
| Common name: | Picture Archiving and Communication System |
| Manufacturer: | GE Medical System, LLC |
| Classification name: | Picture Archiving and Communications System |
| Device classification: | Class II |
| 510(k) clearance number: | K081985 |
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| Reference device no 1 | |
|---|---|
| Trade name: | Extended Brilliance Workplace a component of Brilliance iCT(Brilliance Volume) |
| Common name: | Workstation |
| Manufacturer: | Philips Medical Systems (Cleveland), Inc. |
| Classification name: | System, X-Ray, Tomography, Computed (21 CFR 992.1750, ProductCode JAK) |
| Device classification: | Class II |
| 510(k) clearance number: | K060937 |
| Reference device no 2 | |
| Trade name: | MR Permeability Application |
| Common name: | Picture Archiving and Communication System |
| Manufacturer: | Philips Medical Systems Nederland B.V. |
| Classification name: | Picture Archiving and Communication System (21 CFR 892.2050,Product Code LLZ) |
| Device classification: | Class II |
| 510(k) clearance number: | K130278 |
| Reference device no 3 | |
| Trade name: | ViewForum 2003 |
| Common name: | Picture Archiving and Communication System |
| Manufacturer: | Philips Medical Systems Nederland B.V. |
| Classification name: | Picture Archiving and Communication System (21 CFR 892.2050,Product Code LLZ) |
| Device classification: | Class II |
| 510(k) clearance number: | K032096 |
| Reference device no 4 | |
| Trade name: | IntelliSpace PACS 4.x |
| Common name: | Picture Archiving and Communication System |
| Manufacturer: | Philips Healthcare Informatics, Inc. |
| Classification name: | Picture Archiving and Communication System (21 CFR 892.2050,Product Code LLZ) |
| Device Classification | Class II |
| Clearance Number | K111804 |
| Trade name: | EBW NM 2.0 |
| Common name: | Picture Archiving and Communication System |
| Manufacturer: | Philips Medical Systems (Cleveland), Inc. |
| Classification name: | Picture Archiving and Communication System (21 CFR 892.2050,Product Code LLZ) |
| Device classification: | Class II |
| 510(k) clearance number: | K111336 |
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Reference device no 5
IV. Device description
Philips IntelliSpace Portal Platform is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. This software is for use with offthe-shelf PC computer technology that meets defined minimum specifications.
The IntelliSpace Portal Platform communicates with imaging systems of different modalities using the DICOM-3 standard.
V. Intended use
Philips IntelliSpace Portal Platform is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. This software is for use with offthe-shelf PC computer technology that meets defined minimum specifications.
IntelliSpace Portal Platform is intended to be used by trained professionals, including but not limited to physicians and medical technicians.
This medical device is not to be used for mammography.
The device is not intended for diagnosis of lossy compressed images.
VI. Technological characteristics
Philips believes that IntelliSpace Portal Platform product is substantially equivalent to the predicate GE A W Server legally marketed product with additional/enhanced functionality deriving from the reference devices:
- (K032096) ViewForum2003
- (K060937) Brilliance iCT (Brilliance Volume) EBW Workstation component
- (K130278) MR Permeability including details on IntelliSpace Portal component the next generation of the EBW product,
- I (K111804) IntelliSpace PACS 4.4
- l (K111336) EBW NM 2.0
Below is the comparison table to summarize the similarities and differences of the subject, predicate, and reference devices.
See Conclusion statement at the end of this section for substantial equivalency assessment of the differences indicated in the table.
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| # | Feature/ | IntelliSpace Portal | AW Server | Various (see details |
|---|---|---|---|---|
| Capability | Platform | Predicate Device | below) | |
| Subject Device | (K081985) | Reference Devices | ||
| System Configuration | ||||
| 1 | Standard off theShelf Hardwareand OperatingSystem (OS)requirements | Yes | Yes | Not supported |
| 2 | VMwareSupport | Yes | Yes | Not supported |
| 3 | Thin client-servertechnology | Yes | Yes | Yes(K032096) ViewForum |
| 4 | Dual monitorsupport | 1024x768 and up to3MP | 1024x768 and up to3MP | Not supported |
| 5 | Client multi-resolutiondisplay support | 1024x768 and up to3MP | 1024x768 and up to3MP | Not supported |
| System Applications and Functionality | ||||
| 6 | Multipleconcurrent usersupport | Yes | Yes | Yes(K032096) ViewForum |
| 7 | Patientdirectory /Report/ Film /Worklistapplication | Yes | Not supported | Yes(K032096) ViewForum |
| 8 | PresentationState Support | Yes | Yes | Yes(K032096) ViewForum |
| 9 | Pre-processingand backgroundprocessing | Yes | Yes | Yes(K032096) ViewForum |
| 10 | CD/DVDburning | Yes | Yes | Yes(K032096) ViewForum |
| 11 | USB devicesupport | Yes | Not supported | Yes(K111804) IntelliSpacePACS 4.4 |
| # | Feature/Capability | IntelliSpacePortal PlatformSubject Device | AW ServerPredicateDevice(K081985) | Various (see detailsbelow)Reference Devices |
| 12 | Speech Recognitionsoftware(PowerScribe) forreporting | Yes | Unknown | Yes(K032096) ViewForum |
| 13 | Bookmarks: creating,saving, and loading | Yes | Yes | Not supported |
| 14 | Support of LossyCompression forimprovedperformance | Yes | Yes | Yes(K032096) ViewForum |
| 15 | Licensing | Yes | Unknown | Yes(K130278) MRPermeability includingIntelliSpace Portal |
| 16 | Support of Data Pre-Fetch from remotedevices | Yes | Yes | Yes(K032096) ViewForum |
| 17 | Management tool | Yes | Yes | Yes(K032096) ViewForum |
| Review Modes and Image Manipulation | ||||
| 18 | Support multi-modality data | Yes | Yes | Yes(K032096) ViewForum |
| 19 | 2D slice view, Thinslab/MPR view,3D VolumeRendering/MIP view/MiniP | Yes | Unknown | Yes(K032096) ViewForum |
| 20 | Fusion viewing | Yes | Unknown | Yes(K032096) ViewForum(K111336) EBW NM 2.0 |
| 21 | MR Segmentation | Yes | Unknown | Yes(K032096) ViewForum |
| 22 | Cine viewing | Yes | Yes | Yes(K032096) ViewForum |
| 23 | ImageManipulation:scroll/pan/zoom/rotate/comparison/ merge | Yes | Yes | Yes(K032096) ViewForum |
| # | Feature/ | IntelliSpace Portal | AW Server | Various (see details |
| Capability | Platform | Predicate Device | below) | |
| Subject Device | (K081985) | Reference Devices | ||
| 24 | Send images | Yes | Yes | Yes |
| and views to | (K032096) ViewForum | |||
| film application | ||||
| 25 | Send images | Yes | Yes | Yes |
| and views to a | (K032096) ViewForum | |||
| reportingapplication | ||||
| 26 | Create image | Yes | Yes | Yes |
| annotations | (K032096) ViewForum | |||
| 27 | Measurement | Yes | Yes | Yes |
| and graphics: | (K032096) ViewForum | |||
| ROI, angle, text | ||||
| Communication and Interoperability | ||||
| 28 | Integration with | Yes | Yes | Yes |
| institution's | (K032096) ViewForum | |||
| HIS, RIS, EMR | ||||
| 29 | PACS | Yes | Yes | Not supported |
| integration | ||||
| 30 | Data Streaming | Yes | Unknown | Not supported |
| tool integration | ||||
| 31 | Multi-vendor | Yes | Yes | Not supported |
| Application | ||||
| 32 | plug-inEnterprise | Yes | Yes | Not supported |
| deployment | ||||
| (scalability | ||||
| feature) | ||||
| 33 | Multimodality | Yes | Not supported | Not supported |
| Web Viewer | ||||
| (with any | ||||
| computer) | ||||
| 34 | Multimodality | Yes | Not supported | Not supported |
| Web Viewer -Mobile non- | ||||
| diagnostic | ||||
| viewing | ||||
| (Collaboration | ||||
| Viewer) |
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Listed above technological differences are considered low risk, providing further support to clinicians in visualization or administrative functions. The majority of these functionalities are derived from reference devices and were verified and validated, and do not raise new questions on safety and/or effectiveness.
These features have not changed the intended use and operational principles of the device.
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Therefore, the IntelliSpace Portal Platform is substantially equivalent to the currently marketed predicate device GE AW Server (K081985) in terms of technological characteristics.
Conclusion:
The IntelliSpace Portal Platform is substantially equivalent to the currently marketed predicate device, AW Server (K081985) in terms of indication for use, design features, fundamental scientific technology, and safety and/or effectiveness.
VII. Brief discussion of the nonclinical tests submitted, referenced or relied on
No performance standards for PACS systems or components have been issued under the authority of Section 514. Non-clinical performance testing has been performed on ISPP and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- ı ISO 14971 Medical devices – Application of risk management to medical devices
- IEC 62304 Medical device software - Software life cycle processes
- . NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM)
- . Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
The ISPP system was tested in accordance with Philips verification processes. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results.
The test results in this 510(k) premarket notification demonstrate that ISPP:
- complies with the aforementioned international and FDA-recognized consensus standards and l FDA guidance document, and
- . Meets the acceptance criteria and is adequate for its intended use.
Therefore, ISPP is substantially equivalent to the currently marketed predicate device GE AW Server (K081985) in terms of safety and effectiveness.
VIII, Brief discussion of clinical tests submitted referenced or relied on
The subject of this premarket submission, ISPP does not require clinical studies to support equivalence.
IX. The conclusions drawn from the nonclinical and clinical tests
Verification and Validation activities required to establish performance and functionality of IntelliSpace Portal Platform were performed. Testing involved system level tests, performance tests, and safety testing from Risk Analysis. Testing performed demonstrated the IntelliSpace Portal Platform meets all defined functionality requirements and performance claims.
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| X. Overall conclusion: | The IntelliSpace Portal Platform is substantially equivalent to the predicate device AW Server (K081985) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.Additionally, substantial equivalence was demonstrated with non-clinical performance testing, which complied with the requirements specified in the international and FDA-recognized consensus standards. The non-clinical performance tests provided in this 510(k) premarket notification demonstrate that the subject IntelliSpace Portal Platform is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns. |
|---|---|
| ------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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).