miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer

K171977 · Hinacom Software and Technology, Ltd. · LLZ · Aug 2, 2018 · Radiology

Device Facts

• Record ID: K171977
• Device Name: miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer
• Applicant: Hinacom Software and Technology, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Aug 2, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

miPlatform medical imaging suite v3.0 (miPlaftorm v3.0) is an upgrade of miPlatform medical imaging suite v2.0, previous cleared under K131424. miPlatform v3.0 is an internet-based image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package that is used with general purpose computing hardware to acquire, store, distribute, process and display images and associated patient data. The software supports and performs reviewing, communication and storage from the following modalities through DICOM 3.0 standard: CT, MR, NM, US, XA, PET, DX, CR/DR, RF, RT, MG, SC, VL, ES, OP, XC, PT, OT, as well as hospital/radiology information systems and any other information systems that support DICOM 3.0 standards. Non-radiology modalities are not for diagnostic use. For radiology modalities, only FDA cleared monitors shall be used to review images for diagnostic use. miPlatform ZFP Viewer is offered as extension application to miPlatform medical imaging suite system. This software technology uses HTML5 which allows a browser-enabled device to run the software application, and thus requires no installation (zero foot print). The user is able to access patient images and study reports from a mobile device, such as iPad3, as well as personal computer using Microsoft Windows System, anywhere through a wireless and 3G, 4G network. miPlatform ZFP Viewer has a simple GUI for viewing and includes tools such as zoom, pan, windowing, basic measurement, and 3D visualization functions, including volume rendering and multi-planar reconstruction. Only FDA cleared monitors shall be used to review images for diagnostic use. miPlatform ZFP Viewer provides wireless and portable access to medical images, in addition to standard intranet or internet access. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. When used on a mobile device, the miPlatform ZFP Viewer is not for diagnostic use. For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by the FDA for mammography. MIP/MRP tools are not supported for mammography images for diagnostic use.

Device Story

Internet-based medical imaging management system; acquires, stores, distributes, processes, and displays DICOM 3.0 images/data; used by physicians, nurses, and technicians in clinical settings. Operates on general-purpose computing hardware; ZFP Viewer uses HTML5 for zero-footprint browser access via PC or mobile devices (e.g., iPad). Provides tools for zoom, pan, windowing, measurement, and 3D visualization (volume rendering, multi-planar reconstruction). Supports real-time image-based conferencing with audio/video. Output viewed on FDA-cleared monitors for diagnostic purposes; mobile access intended for non-diagnostic review when workstations are unavailable. Enhances clinical workflow by enabling remote access to images and reports, facilitating timely interpretation and collaborative review.

Clinical Evidence

Bench testing only. Software validation, verification, and performance testing conducted per design control procedures. Included system-level functionality, segmentation/measurement accuracy, interface, usability, and labeling tests. Performance comparison testing on retrospective images demonstrated equivalence to predicates. All tests passed.

Technological Characteristics

Software-based PACS; DICOM 3.0 compliant; HTML5-based ZFP viewer; supports 3D visualization (MPR, volume rendering). Operates on Windows-based PCs and mobile devices (iOS). Connectivity via TCP/IP, wireless, 3G/4G. Standards: NEMA PS3.1-3.18 (DICOM).

Indications for Use

Indicated for trained professionals (physicians, nurses, technicians) to acquire, store, distribute, process, and display medical images and patient data via DICOM 3.0. Supports CT, MR, NM, US, XA, PET, DX, CR/DR, RF, RT, MG, SC, VL, ES, OP, XC, PT, OT. Non-radiology modalities and mobile device usage are not for diagnostic use. Mammography requires FDA-cleared display hardware.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• miPlatform Medical Imaging Suite (K131424)
• CARESTREAM Vue PACS v11.4 Vue Motion (K132824)

Submission Summary (Full Text)

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Hinacom Software and Technology, Ltd. % Yi Isabelle Sun Executive VP Suite B301, R&D Plaza, Tsinghua Science Park Haidian District, Beijing 100084 CHINA

August 2, 2018

# Re: K171977

Trade/Device Name: miPlatform medical imaging suite v3.0, (miPlatform v3.0) miPlatform ZFP Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 20, 2018 Received: June 25, 2018

## Dear Yi Sun:

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 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

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devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jeff Bargo

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) K171977

#### Device Name

miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer

#### Indications for Use (Describe)

miPlatform medical imaging suite v3.0 (miPlaftorm v3.0) is an upgrade of miPlatform medical imaging suite v2.0, previous cleared under K131424. miPlatform v3.0 is an internet-based image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package that is used with general purpose computing hardware to acquire, store, distribute, process and display images and associated patient data. The software supports and performs reviewing, communication and storage from the following modalities through DICOM 3.0 standard: CT, MR, NM, US, XA, PET, DX, CR/DR, RF, RT, MG, SC, VL, ES, OP, XC, PT, OT, as well as hospital/radiology information systems and any other information systems that support DICOM 3.0 standards. Non-radiology modalities are not for diagnostic use. For radiology modalities, only FDA cleared monitors shall be used to review images for diagnostic use.

miPlatform ZFP Viewer is offered as extension application to miPlatform medical imaging suite system. This software technology uses HTML5 which allows a browser-enabled device to run the software application, and thus requires no installation (zero foot print). The user is able to access patient images and study reports from a mobile device, such as iPad3, as well as personal computer using Microsoft Windows System, anywhere through a wireless and 3G, 4G network. miPlatform ZFP Viewer has a simple GUI for viewing and includes tools such as zoom, pan, windowing, basic measurement, and 3D visualization functions, including volume rendering and multi-planar reconstruction. Only FDA cleared monitors shall be used to review images for diagnostic use.

miPlatform ZFP Viewer provides wireless and portable access to medical images, in addition to standard intranet or internet access. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. When used on a mobile device, the miPlatform ZFP Viewer is not for diagnostic use.

For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by the FDA for mammography. MIP/MRP tools are not supported for mammography images for diagnostic use.

| 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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#### 7. 510(k) Summary

#### 7.1. Identification of Submitter

| Submitter: | Hinacom Software and Technology Ltd. Co. |
|------------|------------------------------------------------|
| Address: | Suite B-301, R&D Plaza, Tsinghua Science Park, |
| | Haidian District, Beijing, China 100084 |
| Phone: | [phone] |
| Fax: | [phone] |

| Contact: | Yi Isabelle Sun |
|----------|------------------|
| Title: | Executive VP |
| E-mail: | [e-mail] |
| Phone: | [phone] |
| Fax: | [phone] |

Summary Date: 11/08/2017

#### 7.2. Identification of Product

| Trade name: | miPlatform medical imaging suite v3.0 (miPlatform v3.0),<br>miPlatform ZFP Viewer |
|------------------------|-----------------------------------------------------------------------------------|
| Common/Usual Name: | Picture Archiving and Communications System |
| Classification Name: | System, Image Processing Radiological (21 C.F.R. 892.2050, LLZ) |
| Device Classification: | Class II |
| Manufacturer: | Hinacom Software and Technology, Ltd. |

Primary predicate device:

| Trade/Device Name: | miPlatform Medical Imaging Suite |
|----------------------|---------------------------------------------|
| Common/Usual Name: | Picture Archiving and Communications System |
| Classification Name: | LLZ, Class II, 21 CFR 892.2050 |
| 510(k) Number: | K131424 |

Secondary predicate device:

| Trade Name: | CARESTREAM Vue PACS v11.4 Vue Motion |
|----------------------|---------------------------------------------|
| Common/Usual Name: | Picture Archiving and Communications System |
| Classification Name: | LLZ, Class II, 21 CFR 892.2050 |
| 510(k) Number: | K132824 |

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#### 7.3. Indication for Use

miPlatform medical imaging suite v3.0 (miPlatform v3.0) is an upgrade of miPlatform medical imaging suite v2.0, previous cleared under K131424. miPlatform v3.0 is an internet-based image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package that is used with general purpose computing hardware to acquire, store, distribute, process and display images and associated patient data. The software supports and performs reviewing, communication and storage from the following modalities through DICOM 3.0 standard: CT, MR, NM, US, XA, PET, DX, CR/DR, RF, RT, MG, SC, VL, ES, OP, XC, PT, OT, as well as hospital/radiology information systems and any other information systems that support DICOM 3.0 standards. Non-radiology modalities are not for diagnostic use. For radiology modalities, only FDA cleared monitors shall be used to review images for diagnostic use.

miPlatform ZFP Viewer is offered as extension application to miPlatform medical imaging suite system. This software technology uses HTML5 which allows a browser-enabled device to run the software application, and thus requires no installation (zero foot print). The user is able to access patient images and study reports from a mobile device, such as iPad3, as well as personal computer using Microsoft Windows System, anywhere through a wireless and 3G, 4G network. miPlatform ZFP Viewer has a simple GUI for viewing and includes tools such as zoom, pan, windowing, basic measurement, and 3D visualization functions, including volume rendering and multi-planar reconstruction. Only FDA cleared monitors shall be used to review images for diagnostic use.

miPlatform ZFP Viewer provides wireless and portable access to medical images, in addition to standard intranet or internet access. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. When used on a mobile device, the miPlatform ZFP Viewer is not for diagnostic use.

For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by the FDA for mammography. MIP/MRP tools are not supported for mammography images for diagnostic use.

### 7.4.Device description

miPlatform v3.0 and miPlatform ZFP Viewer is the extension application software of miPlatform medical imaging information system. User can achieve mobile office through the software which is installed in PC, smart mobile phone and other mobile terminals.

- . Understanding and analyzing patient's information and medical image in real time.
- . Processing, diagnosing and sharing images in real time. Note that when used on a mobile device, the miPlatform ZFP Viewer is not for diagnostic use.
- . Support three-dimensional image viewing and processing.

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- Support image analysis and real-time data synchronization exchange in real-time conference.
Detail description of functionalities and technical characteristics can be found in Section 7.6 of this document.

# 7.5. Software Development

Hinacom certifies that the miPlatform v3.0 and miPlatform ZFP Viewer software are designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. The software developed for this product is used to provide diagnostic quality images and associated information to the intended users.

| | Device being submitted for<br>510(k) | Predicate device | Predicate device |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | miPlatform Medical<br>Imaging Suite v3.0,<br>miPlatform ZFP Viewer | miPlatform Medical<br>Imaging Suite v2.0 | CARESTREAM<br>Vue PACS v11.4<br>Vue Motion |
| 510(k)<br>number | K171977 | K131424 | K132824 |
| Manufact<br>urer | Hinacom Software and<br>Technology, Ltd | Hinacom Software and<br>Technology, Ltd | Carestream<br>Health, Inc. |
| Class | Class II | Class II | Class II |
| Product<br>code | LLZ | LLZ | LLZ |
| Indication<br>for Use | miPlatform medical imaging<br>suite v3.0 (miPlatform v3.0)<br>is an upgrade of miPlatform<br>medical imaging suite v2.0,<br>previous cleared under<br>K131424. miPlatform v3.0<br>is an internet-based image<br>management system<br>intended to be used by<br>trained professionals,<br>including but not limited to | miPlatform is an internet-<br>based image<br>management system<br>intended to be used by<br>trained professionals,<br>including but not limited<br>to physicians, nurses and<br>medical technicians.<br>The system is a software<br>package that is used with | The<br>CarestreamVue<br>PACS is an image<br>management<br>system whose<br>intended use is to<br>provide completely<br>scalable local and<br>wide area PACS<br>solution for<br>hospital and related |
| physicians, nurses and<br>medical technicians. The<br>system is a software package<br>that is used with general<br>purpose computing<br>hardware to acquire, store,<br>distribute, process and<br>display images and<br>associated patient data. The<br>software supports and<br>performs reviewing,<br>communication and storage<br>from the following<br>modalities through DICOM<br>3.0 standard: CT, MR, NM,<br>US, XA, PET, DX, CR/DR,<br>RF, RT, MG, SC, VL, ES,<br>OP, XC, PT, OT, as well as<br>hospital/radiology<br>information systems and any<br>other information systems<br>that support DICOM 3.0<br>standards. Non-radiology<br>modalities are not for<br>diagnostic use. For<br>radiology modalities, only<br>FDA cleared monitors shall<br>be used to review images for<br>diagnostic use. | general purpose<br>computing hardware to<br>acquire, store, distribute,<br>process and display<br>images and associated<br>data. The software<br>performs digital image<br>processing, analysis,<br>reviewing,<br>communication and<br>storage.<br><br>miPlatform supports<br>receiving, sending,<br>printing, storing and<br>displaying studies<br>received from the<br>following modality types<br>via DICOM: CT, MR,<br>NM, US, XA, PET, DX,<br>DR, RF, RT, MG, SC,<br>VL, as well as<br>hospital/radiology<br>information systems and<br>any other information<br>systems that support<br>DICOM 3.0 standard.<br><br>miPlatform also supports<br>multidimensional image<br>visualization,<br>measurement and<br>analysis tools, and<br>reporting algorithms. The<br>user interface is designed<br>to follow typical clinical<br>workflow patterns to<br>process, review,<br>validate/edit and analyze<br>digital images. The<br>software supports the | institutions/ sites<br>which will archive,<br>distribute, retrieve<br>and display images<br>and data from all<br>hospital modalities<br>and information<br>systems.<br><br>The system<br>contains interactive<br>tools in order to<br>ease the process of<br>analyzing and<br>comparing three<br>dimensional (3D)<br>images. It is a<br>single system that<br>integrates review,<br>dictation and<br>reporting tools to<br>create a productive<br>work environment<br>for the radiologists<br>and physicians.<br><br>The<br>CarestreamVue<br>motion software<br>program is used for<br>patient<br>management by<br>clinicians in order<br>to access and<br>display patient<br>data, medical<br>reports, and<br>medical images for<br>diagnosis from<br>different modalities<br>including CR, DR | |
| miPlatform ZFP Viewer is<br>offered as extension<br>application to miPlatform<br>medical imaging suite<br>system. This software<br>technology uses HTML5<br>which allows a browser-<br>enabled device to run the<br>software application, and<br>thus requires no installation<br>(zero foot print). The user is | | | |
| able to access patient images | following image analysis options: | CT, MR, NM and US. | |
| and study reports from a<br>mobile device, such as<br>iPad3, as well as personal<br>computer using Microsoft<br>Windows System, anywhere<br>through a wireless and 3G,<br>4G network. miPlatform<br>ZFP Viewer has a simple<br>GUI for viewing and<br>includes tools such as zoom,<br>pan, windowing, basic<br>measurement, and 3D<br>visualization functions,<br>including volume rendering<br>and multi-planar<br>reconstruction. Only FDA<br>cleared monitors shall be<br>used to review images for<br>diagnostic use. | Vessel Analysis is an<br>option intended for<br>determining the presence<br>and extent of vascular<br>obstructive disease by<br>providing a non-invasive<br>survey of a patient's<br>coronary or peripheral<br>arteries. Physicians can<br>select any artery to view<br>the following anatomical<br>references: the<br>highlighted vessel in 3D,<br>two rotate-able curved<br>MPR vessel views<br>displayed at angles<br>orthogonal to each other,<br>and cross sections of the<br>vessel. Physicians can<br>manually measure the<br>lumen width to obtain<br>percentage stenosis<br>calculations. In addition,<br>clinicians can manually<br>measure vessel length<br>along the centerline in<br>standard curved MPR<br>views and examine<br>Hounsfield unit or signal<br>intensity statistics. | Carestream Vue<br>Motion provides<br>wireless and<br>portable access to<br>medical images for<br>remote reading or<br>referral purposes<br>from browsers<br>including usage<br>with validated<br>mobile devices.<br><br>This device is not<br>intended to replace<br>full workstations<br>and should be used<br>only when there is<br>no access to a<br>workstation. For<br>primary<br>interpretation and<br>review of<br>mammography<br>images, only use<br>display hardware<br>that is specifically<br>designed for and<br>cleared by the FDA<br>for mammography. | |
| miPlatform ZFP Viewer<br>provides wireless and<br>portable access to medical<br>images, addition to standard<br>intranet or internet access.<br>This device is not intended to<br>replace full workstations and<br>should be used only when<br>there is no access to a<br>workstation. When used<br>on a mobile device, the<br>miPlatform ZFP Viewer is<br>not for diagnostic use. | Coronary Calcium<br>Scoring is an option<br>intended for cardiac<br>scoring from CT image<br>derived measurements,<br>including non-invasive<br>detection and | | |
| For primary interpretation<br>and review | of mammography images, only<br>use display hardware that is<br>specifically designed for and<br>cleared by the FDA for | | |
| | | | |
| | mammography. MIP/MRP<br>tools are not supported for<br>mammography images for<br>diagnostic use. | quantification of<br>atherosclerotic plaque.<br>Physicians can use semi-<br>automatic tools in<br>Coronary Calcium<br>Scoring to mark calcified<br>lesions of coronary<br>arteries, and automated<br>computation of Agatston<br>scoring will be<br>performed and presented<br>in a report.<br><br>miPlatform supports a<br>real-time image-based<br>conference option with<br>integrated audio/video<br>capability. Multiple users<br>may log into the system<br>and participate in the<br>conference from different<br>locations via internet<br>connection. | |
| Graphical<br>UI | Yes | Yes | Yes |
| Window<br>O.S. -<br>Client | Yes | Yes | Yes |
| Image<br>input<br>DICOM<br>3.0 | Yes | Yes | Yes |
| Images<br>stored on<br>remote<br>server | Yes | Yes | Yes |
| Network<br>Protocol:<br>TCP-IP | Yes | Yes | Yes |
| Query,<br>retrieve | Yes | Yes | Yes |
| | | | |
| display, store and process digital medical images | | | |
| Display of patient data | Yes…