(15 days)
Not Found
No
The summary describes a standard image processing workstation with various modules, but there is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
The device is described as an image processing workstation for viewing, manipulating, and storing medical images for diagnosis, not for treating a disease or condition.
No
Explanation: The device is an image processing workstation that displays and processes images from diagnostic systems; it does not itself perform diagnosis. The document states that images "may be used as a basis for diagnosis, except in the case of mammography images," indicating that the diagnosis is made by a trained physician interpreting the images displayed by the device, not by the device itself.
No
The device description explicitly states that the AZE VirtualPlace "consists of workstation, monitor, keyboard and mouse," indicating it includes hardware components in addition to software.
Based on the provided information, the AZE VirtualPlace 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.
- AZE VirtualPlace function: The AZE VirtualPlace is an image processing workstation that works with medical images (DICOM) from imaging systems like CT and MRI. It processes, displays, and manipulates these images for interpretation by a physician.
- No sample analysis: The device does not analyze biological samples from the patient. Its input is image data, not biological material.
Therefore, the AZE VirtualPlace falls under the category of medical imaging software or a picture archiving and communication system (PACS) component, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
The AZE VirtualPlace utilizes DICOM images as it facilitates reviewing, printing, storing, communications, and transferring multi-modality images from a variety of diagnostic imaging systems, such as CT, MR. The AZE VirtualPlace consists of workstation, monitor, keyboard and mouse. The AZE VirtualPlace is provided as basic software with additional software modules available for various features/functions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI, or from image archives
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
The AZE VirtualPlace is substantially equivalent to the predicate devices based on the descriptive data, compliance with standards, software features and indications for use.
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.
K052995, K032096, K051528, K050703, K052467
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
2060453
AZE VirtualPlace Premarket Notification
2006 MAR 9
510(k) Summary
Submitter
Date Prepared 08 March 2006
AZE, Ltd. Ohtemachi-Nomura Bldg 10F, 2-1-1 Ohte-machi, Chiyoda-ku, Tokyo 100-0004, Japan Contact Person: Noriko Saitoh Telephone: +81-3-5255-7721 Fax: +81-3-5255-7722
Name of Device
PACS Workstation Common Name: AZE VirtualPlace Proprietary Name: Classification Name: Picture Archiving and Communications System Regulation: 892.2050 Class: II Product Code: 90 LLZ
Predicate Devices
The AZE VirtualPlace is substantially equivalent in intended use, function, and features to the currently marketed devices:
GE Advantage Workstation 4.3, K052995;
Philips Medical Systems ViewForum 2003, K032096;
1 mmpo Freated - System - Software from MeVis Technology GmbH & Co. KG. K051528;
QBrain software from Medis Medical Imaging Systems, B.V., K050703; BrainViewRx Viewer Version 1.0 from Kyron Clinical Imaging, Inc., K052467.
Device Description
The AZE VirtualPlace utilizes DICOM images as it facilitates reviewing, printing, storing, communications, and transferring multi-modality images from a variety of diagnostic imaging systems, such as CT, MR. The AZE VirtualPlace consists of workstation, monitor, keyboard and mouse. The AZE VirtualPlace is provided as basic software with additional software modules available for various features/functions.
Intended Use
AZE VirtualPlace is an image processing workstation that accepts, transfers, displays, stores, ALL vitally processes DICOM medical images from a variety of diagnostic imaging systems (such as CT, MRI, or from image archives) for viewing, image manipulation, (Such as CT) MTC, of Homnd 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. diffilized inin berein migges only be interpreted using an FDA approved monitor that offers
1
AZE VirtualPlace Premarket Notification
at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted bv FDA.
Technological Characteristics
The AZE VirtualPlace has similar technological characteristics to the currently marketed predicate devices listed above. The AZE VirtualPlace components meet the following standards:
IEC 60950:1994, Safety of Information Technology Equipment
IEC 60601-1-2:2001, Medical Electrical Equipment - PART 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
RFI Emission: EN 55022:1998 Class A: Product family standard
EN61000-3-2:2000 Class D: Limits for harmonic current emission EN61000-3-3; 1995+a1:2001: Limitation of voltage fluctuation and flicker
in low-voltage supply system
Immunity: EN 55024:1998 Product family standard Digital Imaging and Communications in Medicine (DICOM) Standard (2004)
Joint Photographic Experts Group (JPEG) images are in compliance with ISO/IEC 10918-1 standard
Performance Data (non-clinical or clinical)
The AZE VirtualPlace is substantially equivalent to the predicate devices based on the descriptive data, compliance with standards, software features and indications for use.
Conclusion
The technological characteristics and performance data for the AZE VirtualPlace demonstrates it is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 MAR 9
AZE, Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K060453 Trade/Device Name: AZE Virtual Place Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 20, 2006 Received: February 22, 2006
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
AZE VirtualPlace Premarket Notification
Indications for Use
1506 645 510(k) Number: Not assigned
Device Name: AZE VirtualPlace
Indications For Use:
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 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Prescription Use X X (21 CFR 801.Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David B. Lymm
Division Sign-Off Division of Reproductive, Abdomin and Radiological Devic 510(k) Number
Section 4
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