AZE VIRTUALPLACE

K060453 · Aze, Ltd. · LLZ · Mar 9, 2006 · Radiology

Device Facts

• Record ID: K060453
• Device Name: AZE VIRTUALPLACE
• Applicant: Aze, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Mar 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended 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.

Device Story

AZE VirtualPlace is a PACS workstation for reviewing, printing, storing, and processing multi-modality DICOM images (CT, MRI). System comprises workstation, monitor, keyboard, and mouse. Software modules provide various image manipulation and quantification features. Used in clinical settings by physicians to interpret images for diagnostic purposes. Output consists of displayed or printed images used to support clinical decision-making. Benefits include centralized image management and advanced visualization tools for diagnostic review.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on descriptive data, compliance with international safety and performance standards (IEC, ISO), and software feature comparison to predicate devices.

Technological Characteristics

Workstation-based PACS system. Components: workstation, monitor, keyboard, mouse. Standards: IEC 60950 (Safety), IEC 60601-1-2 (EMC), EN 55022/55024 (RFI/Immunity), DICOM 2004, ISO/IEC 10918-1 (JPEG). Connectivity: DICOM-compliant. Software: Modular architecture for image processing and quantification.

Indications for Use

Indicated for use by trained physicians to view, manipulate, communicate, print, and quantify DICOM medical images from diagnostic imaging systems (e.g., CT, MRI). Contraindicated for primary interpretation of lossy compressed mammographic images and digitized film screen images. Mammography interpretation requires an FDA-approved monitor with at least 5 Mpixel resolution.

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

• 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)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

#### 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

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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.

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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.

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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 [phone] or [phone] 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

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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

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