AZE PHOENIX SOFTWARE

K133521 · Aze, Ltd. · LLZ · Apr 11, 2014 · Radiology

Device Facts

• Record ID: K133521
• Device Name: AZE PHOENIX SOFTWARE
• Applicant: Aze, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Apr 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

AZE Phoenix software is intended as a radiological review station and for comparison of medical images from multiple imaging modalities and/or time-points. When interpreted by a trained radiologist the images displayed in Phoenix may be used as a basis for diagnosis. AZE Phoenix supports review and comparison by collecting all image data associated with a patient from disparate data servers, modalities, and time-points in a patient centric data list. Users select images from the patient data list for qualitative visual inspection of individual study images and comparison of aligned side-by-side studies or fused visualizations. Users can also make quantitative anatomical measurements in the images including RECIST guideline measurements and save measurements to track changes over time in graphical plots. After selection and comparison of time-series images, individual images may be loaded into AZE VirtualPlace™ workstation which is launched directly from Phoenix for series specific analysis. In summary, Phoenix enables medical image inspection and diagnosis along with qualitative and quantitative comparison of patient images over time followed by in depth analysis in AZE VirtualPlace™ workstation. AZE Phoenix is not indicated for mammography use. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Device Story

AZE Phoenix is a distributed client-server radiological review station; aggregates DICOM images from disparate servers/modalities (CT, MR, US, PET, SPECT) into patient-centric lists. Enables side-by-side display, fusion, and time-series comparison. Provides tools for 2D length/angle/size measurements, RECIST guideline quantification, and graphical tracking of changes. Allows image alignment via registration; supports launching AZE VirtualPlace workstation for in-depth analysis. Used by radiologists in clinical settings to facilitate diagnosis and monitor disease progression. Benefits include streamlined multi-modality review and longitudinal tracking of anatomical changes.

Clinical Evidence

Bench testing only. Validation included software verification, geometric/intensity measurement accuracy using phantom and clinical CT/MRI images, and image registration/fusion validation using human breath cycle CT time series. No clinical data presented.

Technological Characteristics

Distributed client-server software architecture. DICOM-compliant. Features: multiplanar reconstruction (MPR), interpolation-based reslicing, intensity-averaging slab thickness adjustment, image registration, and quantitative measurement tools (diameter, angle, ratio, ROI area, mean intensity, intensity histogram).

Indications for Use

Indicated for use by trained radiologists as a radiological review station for qualitative and quantitative comparison of multi-modality medical images (CT, MR, US, PET, SPECT) across time-points to assist in diagnosis. Not indicated for mammography.

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

• VirtualPlace (K060453)
• syngo.PET & CT Oncology (K093621)
• syngo.via (K123375)

Submission Summary (Full Text)

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K133521

# Traditional 510(k) Summary

APR 1 1 2014

Submitter: AZE Ltd. Marunouchi Trust Tower NORTH 13F 1-8-1 Marunouchi Chiyoda-ku Tokyo 100-0005, Japan

Contact: Karl Diedrich, Ph.D. Office: 1-617-475-1502 Fax: [phone] [e-mail]

Date Prepared: April 7, 2014

Establishment Registration 3005664732 Number:

| Trade Name: | AZE Phoenix |
|------------------------|----------------------------------------------|
| Common Name: | System, Image Processing, Radiology |
| Device Classification: | Picture, archiving, and communication system |
| Class: | II |
| Product Code: | LLZ |
| Classification Panel: | 892 2050 |

Predicate Device(s):

Predicate Device(s): K060453, VirtualPlace, AZE, Ltd. K093621, syngo.PET & CT Oncology, Siemens AG Healthcare SY K123375, syngo.via, Siemens AG Healthcare SY

Device Description:

AZE Phoenix is a distributed client-server radiological review station that allows easy selection, review, processing and time-series comparison of multi-modality DICOM-compliant radiological images of patients. The AZE Phoenix software accepts, transfers, displays, stores, and digitally processes DICOM medical images from a variety of diagnostic imaging systems (such as CT, MRI, or image archives) for viewing image manipulation, communication, printing, and quantification. AZE Phoenix queries, retrieves, and sends DICOM compliant radiological images of patients to and from any number of DICOM Picture Archiving and Communication Systems (PACS) images sources. Phoenix collects all retrieved image series from all time-points and imaging modalities associated with a patient in a single patient centric list. Phoenix capabilities include: side-by-side and fusion image display; two-dimensional length, size, and angle measurements; Response Evaluation Criteria in Solid Tumors (RECIST) guideline measurements; image alignment by registration; tagging images to rapidly query and display image; customizable hanging protocol display

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layouts; and the ability to push specific image series to AZE VirtualPlace™ workstation (cleared under K060453) for in depth series specific analysis.

Intended Use:

AZE Phoenix software is intended as a radiological review station and for comparison of medical images from multiple imaging modalities and/or time-points. When interpreted by a trained radiologist the images displayed in Phoenix may be used as a basis for diagnosis. AZE Phoenix supports review and comparison by collecting all image data associated with a patient from disparate data servers, modalities, and time-points in a patient centric data list. Users select images from the patient data list for qualitative visual inspection of individual study images and comparison of aligned side-by-side studies or fused visualizations. Users can also make quantitative anatomical measurements in the images including RECIST guideline measurements and save measurements to track changes over time in graphical plots. After selection and comparison of time-series images, individual images may be loaded into AZE VirtualPlace™ workstation which is launched directly from Phoenix for series specific analysis. In summary, Phoenix enables medical image inspection and diagnosis along with qualitative and quantitative comparison of patient images over time followed by in depth analysis in AZE VirtualPlace™ workstation.

AZE Phoenix is not indicated for mammography use. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

#### Technological Characteristics:

Performance Testing (Bench):

Similar technological characteristics to currently marketed predicate device listed above. See comparison table, below.

- Formal software verification and validation .
- Measurement validation using CD ROM phantom CT images, clinical CT and MRI images comparing subject and predicate (VirtualPlace) geometric measurements, intensity measurements and free drawing RECIST measurements showed no significant differences.
- Alignment and fusion image display validation using human breath cycle CT time series images comparing registration methods showed significant improvement in alignment from DICOM header patient orientation information to full registration to liver target registration.

## Performance Testing (Animal or Clinical):

### None

Substantial Equivalence Rationale:

The technological characteristics and performance data for the AZE Phoenix software demonstrates it is substantially equivalent to the predicate devices. See comparison table, below. The differences in

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indications for use for the subject and predicate devices are primarily in the degree of description and are not critical to the intended use of the devices and do not affect the safety or effectiveness of the device when used as labeled.

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echnological Comparison of Phoenix vs Predicate Devices

| Feature | Phoenix<br>(K133521) | VirtualPlace<br>(K060453) | Syngo.PET & CT Oncology<br>(K093621) | Syngo.Via<br>(K123375) |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | AZE Phoenix software is<br>intended as a radiological<br>review station and for<br>comparison of medical images<br>from multiple imaging<br>modalities and/or time-points.<br>When interpreted by a trained<br>radiologist the images<br>displayed in Phoenix may be<br>used as a basis for diagnosis.<br>AZE Phoenix supports review<br>and comparison by collecting<br>all image data associated with<br>a patient from disparate data<br>servers, modalities, and time-<br>points in a patient centric data<br>list. Users select images from<br>the patient data list for<br>qualitative visual inspection of<br>individual study images and<br>comparison of aligned side-by-<br>side studies or fused<br>visualizations. Users can also<br>make quantitative anatomical<br>measurements in the images<br>including RECIST guideline<br>measurements and save<br>measurements to track<br>changes over time in graphical<br>plots. After selection and<br>comparison of time-series<br>images, individual images may<br>be loaded into AZE | AZE VirtualPlace is an image<br>processing workstation that<br>accepts, transfers, displays,<br>stores, and digitally processes<br>DICOM medical images from a<br>variety of diagnostic imaging<br>systems (such as CT, MRI, or<br>from image archives) for viewing,<br>image manipulation,<br>communication, printing, and<br>quantification. When interpreted<br>by a trained physician, filmed or<br>displayed images on the<br>VirtualPlace monitor may be<br>used as a basis for diagnosis,<br>except in the case of<br>mammography images. Lossy<br>compressed mammographic<br>images and digitized film screen<br>images must not be reviewed for<br>primary image interpretations.<br>Mammographic images may only<br>be interpreted using an FDA<br>approved monitor that offers at<br>least 5M pixel resolution and<br>meets other technical<br>specifications reviewed and<br>accepted by FDA. | Syngo.PET & CT Oncology is a<br>medical diagnostic application<br>for viewing, manipulation, 3D-<br>visualization and comparison of<br>medical images from multiple<br>imaging modalities and/or time-<br>points. The application supports<br>functional data, such as PET or<br>SPECT as well as anatomical<br>datasets, such as CT or MR.<br>Syngo.PET & CT Oncology<br>enables visualization of<br>information that would<br>otherwise have to be visually<br>compared disjointly. Syngo.PET<br>& CT Oncology provides<br>analytical tools to help the user<br>assess, and document changes in<br>morphological or functional<br>activity at diagnostic and therapy<br>follow-up examinations.<br>Syngo.PET & CT Oncology is<br>designed to support the<br>oncological workflow including<br>interpretation and evaluation of<br>examination, and follow up<br>documentation of findings. | Syngo.via is a software solution<br>intended to be used for viewing,<br>manipulation, communication,<br>and storage of medical images. It<br>can be used as a stand-alone<br>device or together with a variety<br>of cleared and unmodified syngo<br>based software options.<br>Syngo.via supports<br>interpretation and evaluation of<br>examinations within healthcare<br>institutions, for example, in<br>Radiology, Nuclear Medicine,<br>and Cardiology environments.<br>The system is not intended for<br>the displaying of digital<br>mammography images for<br>diagnosis in the U.S. |
| Feature | Phoenix<br>(K133521) | VirtualPlace<br>(K060453) | Syngo.PET & CT Oncology<br>(K093621) | Syngo.Via<br>(K123375) |
| | VirtualPlaceTM workstation<br>which is launched directly from<br>Phoenix for series specific<br>analysis. in summary Phoenix<br>enables medical image<br>inspection and diagnosis along<br>with qualitative and<br>quantitative comparison of<br>patient images over time<br>followed by in depth analysis<br>in AZE VirtualPlaceTM<br>workstation.<br>AZE Phoenix is not indicated<br>for mammography use. Lossy<br>compressed mammographic<br>images and digitized film<br>screen images must not be<br>reviewed for primary image<br>interpretations.<br>Mammographic images may<br>only be interpreted using an<br>FDA-approved monitor that<br>offers at least 5 Mpixel<br>resolution and meets other<br>technical specifications<br>reviewed and accepted by<br>FDA. | | | |
| Input Image | DICOM compliant radiological<br>images | DICOM compliant radiological<br>images | DICOM compliant radiological<br>images | DICOM compliant radiological<br>images |
| Image Modality(s) | CT, MR, US, PET, SPECT | CT, MR, US, PET, SPECT | CT, PET, SPECT | CT, MR, US, PET, SPECT |
| Phoenix<br>(K133521) | VirtualPlace<br>(K060453) | Syngo.PET & CT Oncology<br>(K093621) | Syngo.Via<br>(K123375) | |
| Multiplanar reconstruction<br>(MPR) | Multiplanar reconstruction<br>(MPR) | [Not specified] | Multiplanar reconstruction<br>(MPR) | |
| Reslice images using<br>interpolation | Reslice images using<br>interpolation | [Not specified] | Reslice images using<br>interpolation | |
| Segmentation | | | Segmentation | |
| Image Registration | | | Image Registration | |
| Change slab thickness by<br>intensity averaging | Change slab thickness by<br>intensity averaging | | Change slab thickness by<br>intensity averaging | |
| Anatomical line measurements<br>• Diameter<br>• Angle<br>• Ratio | Anatomical line measurements<br>• Diameter<br>• Angle<br>• Ratio | | | |
| Region of interest (ROI)<br>• Area<br>• Mean intensity<br>• Intensity histogram | Region of interest (ROI)<br>• Area<br>• Mean intensity<br>• Intensity histogram | | Region of interest (ROI)<br>• Area<br>• Mean intensity<br>• Intensity histogram | |
| Tumor time-point comparison | | | Tumor time-point comparison | |

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WObbi-G Silver Spring, MD 20993-0002

April 11, 2014

AZE, Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Service. LI.C 1394 25TH STREET NW BUFFAI.O MN 55313

Re: K133521

Trade/Device Name: AZE Phoenix Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 14, 2014 Received: March 18, 2014

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRFI does not cyaluate 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.

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Page 2-Mr. Job

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dcfault.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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Michael D. O'Hara . For

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133521

Device Name AZE Phoenix

#### Indications for Use (Describe)

AZE Phoenix software is intended as a radiological review station and for comparison of medical images from multiple imaging modalities and/or time-points. When interpreted by a trained radiologist the images displayed in Phoenix may be used as a basis for diagnosis. AZE Phoenix supports review and comparison by collecting all image data associated with a patient from disparate data servers, modalities, and time-points in a patient centric data list. Users select images from the patient data list for qualitative visual individual study images and comparison of aligned side-by-side studies or fused visualizations. Users can also make quantitative anatomical measurements in the images including RECIST guideline measurements and save measurements to track changes over time in graphical plots. After selection and comparison of time-series images may be loaded into AZE VirtualPlaceTM workstation which is launched directly from Phoenix for series specific analysis. In summary, Phoenix enables medical image inspection and diagnosis along with qualitative and quantitative comparison of patient images over time followed by in depth analysis in AZE VirtualPlaceTM workstation.

AZE Phoenix is not indicated for mammography use. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | <img alt="Signature" src="signature.png"/> |
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