(147 days)
Not Found
No
The summary describes a radiological review station with standard image processing, comparison, and measurement tools. There is no mention of AI, ML, or related terms, nor any description of training or test sets typically associated with AI/ML device submissions.
No.
AZE Phoenix is a radiological review station used for displaying and comparing medical images for diagnosis, not for providing therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "When interpreted by a trained radiologist the images displayed in Phoenix may be used as a basis for diagnosis." This directly indicates its role in the diagnostic process.
Yes
The device description explicitly states "AZE Phoenix software" and describes its functions as software-based operations on DICOM images. While it interacts with hardware (imaging systems, PACS, monitors), the device itself, as described, is the software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The AZE Phoenix software is a radiological review station that processes and displays medical images (CT, MRI, etc.) acquired from imaging modalities. It does not analyze samples taken from the body.
- Intended Use: The intended use is for the review and comparison of medical images by trained radiologists for diagnosis. This is based on visual interpretation of images, not analysis of biological samples.
The device is clearly focused on the processing and display of medical images obtained through imaging techniques, which falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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 layouts; and the ability to push specific image series to AZE VirtualPlace™ workstation (cleared under K060453) for in depth series specific analysis.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM compliant radiological images, CT, MR, US, PET, SPECT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing (Bench):
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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: 1-617-588-1889 karl.diedrich@azetech.com
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
1
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
2
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.
. .
and the comments of the country
..
,
3
echnological Comparison of Phoenix vs Predicate Devices
| Feature | Phoenix
(K133521) | VirtualPlace
(K060453) | Syngo.PET & CT Oncology
(K093621) | Syngo.Via
(K123375) |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
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 | AZE VirtualPlace is an image
processing workstation that
accepts, transfers, displays,
stores, and digitally processes
DICOM medical images from a
variety of diagnostic imaging
systems (such as CT, MRI, or
from image archives) for viewing,
image manipulation,
communication, printing, and
quantification. When interpreted
by a trained physician, filmed or
displayed images on the
VirtualPlace monitor may be
used as a basis for diagnosis,
except in the case of
mammography images. 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 5M pixel resolution and
meets other technical
specifications reviewed and
accepted by FDA. | Syngo.PET & CT Oncology is a
medical diagnostic application
for viewing, manipulation, 3D-
visualization and comparison of
medical images from multiple
imaging modalities and/or time-
points. The application supports
functional data, such as PET or
SPECT as well as anatomical
datasets, such as CT or MR.
Syngo.PET & CT Oncology
enables visualization of
information that would
otherwise have to be visually
compared disjointly. Syngo.PET
& CT Oncology provides
analytical tools to help the user
assess, and document changes in
morphological or functional
activity at diagnostic and therapy
follow-up examinations.
Syngo.PET & CT Oncology is
designed to support the
oncological workflow including
interpretation and evaluation of
examination, and follow up
documentation of findings. | Syngo.via is a software solution
intended to be used for viewing,
manipulation, communication,
and storage of medical images. It
can be used as a stand-alone
device or together with a variety
of cleared and unmodified syngo
based software options.
Syngo.via supports
interpretation and evaluation of
examinations within healthcare
institutions, for example, in
Radiology, Nuclear Medicine,
and Cardiology environments.
The system is not intended for
the displaying of digital
mammography images for
diagnosis in the U.S. |
| Feature | Phoenix
(K133521) | VirtualPlace
(K060453) | Syngo.PET & CT Oncology
(K093621) | Syngo.Via
(K123375) |
| | 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. | | | |
| Input Image | DICOM compliant radiological
images | DICOM compliant radiological
images | DICOM compliant radiological
images | DICOM compliant radiological
images |
| Image Modality(s) | CT, MR, US, PET, SPECT | CT, MR, US, PET, SPECT | CT, PET, SPECT | CT, MR, US, PET, SPECT |
| Phoenix
(K133521) | VirtualPlace
(K060453) | Syngo.PET & CT Oncology
(K093621) | Syngo.Via
(K123375) | |
| Multiplanar reconstruction
(MPR) | Multiplanar reconstruction
(MPR) | [Not specified] | Multiplanar reconstruction
(MPR) | |
| Reslice images using
interpolation | Reslice images using
interpolation | [Not specified] | Reslice images using
interpolation | |
| Segmentation | | | Segmentation | |
| Image Registration | | | Image Registration | |
| Change slab thickness by
intensity averaging | Change slab thickness by
intensity averaging | | Change slab thickness by
intensity averaging | |
| Anatomical line measurements
• Diameter
• Angle
• Ratio | Anatomical line measurements
• Diameter
• Angle
• Ratio | | | |
| Region of interest (ROI)
• Area
• Mean intensity
• Intensity histogram | Region of interest (ROI)
• Area
• Mean intensity
• Intensity histogram | | Region of interest (ROI)
• Area
• Mean intensity
• Intensity histogram | |
| Tumor time-point comparison | | | Tumor time-point comparison | |
・
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4
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.
4
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5
・
6
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.
7
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
8
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) | |
|---|---|
| ------------------------------------------------------------------------------ | -------------------------------------------- |
9
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