BEYONDIMAGE WORKSTATION

K102435 · Neusoft Medical Systems Co., Ltd. · LLZ · Oct 15, 2010 · Radiology

Device Facts

• Record ID: K102435
• Device Name: BEYONDIMAGE WORKSTATION
• Applicant: Neusoft Medical Systems Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Oct 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

BeyondImage Workstation is a software application that is used for viewing medical images. Beyond mage Workstation receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and digital radiographic devices). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Taking that users may perform when viewing images include, but are not limited to adjustment of window width and center; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images, it also provides standard Multi-Planar Reconstruction (MPR) views, Curved-Planar Reconstruction (CPR) views and 3D views of Volume Rendering for digital images from CT, MR, and PET unit. In addition, using Beyondlmage Workstation, users can edit and print report. Beyondlmage Workstation cannot display and process mammograms.

Device Story

BeyondImage Workstation is a software-only PACS application for diagnostic imaging environments. It receives DICOM-formatted images from various modalities (CT, MR, US, RF, CR, DR, PET) via network or local storage. Trained medical professionals (radiologists, clinicians, technologists) operate the workstation on standard Windows hardware. The software provides tools for image manipulation, including window/level adjustment, stacking, annotation, measurement, rotation, and flipping. It performs advanced visualization, including Multi-Planar Reconstruction (MPR), Curved-Planar Reconstruction (CPR), and 3D Volume Rendering. Users can also edit and print clinical reports. The device facilitates diagnostic decision-making by enabling efficient review and analysis of medical imaging studies across distributed clinical networks.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics and functional specifications to predicate devices.

Technological Characteristics

Software-only application; runs on standard Windows-based computer hardware. Supports DICOM 3.0 protocol for image communication, storage, and Query/Retrieve. Features include window/level adjustment, image stacking, annotation, measurement, rotation, flipping, MPR, CPR, and 3D Volume Rendering. Not for mammography.

Indications for Use

Indicated for trained medical professionals (radiologists, clinicians, technologists) to view, process, and manipulate digital medical images (CT, MR, US, RF, CR, DR, PET) for diagnostic purposes. Contraindicated for mammography imaging.

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

• BeyondImage Workstation 1.0 (K092235)
• Barco Voxar 3D 6.1 (K060505)

Submission Summary (Full Text)

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510(k)

#### Summary of Safety and Effectiveness K102438

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This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)

## General Information:

| Trade Name: | BeyondImage Workstation |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Version Number: | 2.0 |
| Common Name: | Picture Archiving and Communication System (PACS) |
| CFR Section: | 21 CFR Part 892.2050 |
| Classification Name: | Picture Archiving and Communication System (PACS). |
| Product Code: | LLZ |
| Device Class: | Class II |
| Manufacturer and<br>Distributor: | Neusoft Medical Systems Co., Ltd.<br>No.16, Shiji Road, Hunnan Industrial Area,<br>Shenyang, Liaoning, China<br>Post Code : 110179 |
| Submitter: | Contact : Tian Yuehui<br>Title : Manager of Quality Management Department<br>Tel : [phone]<br>Fax : [phone]<br>E-Mail : [e-mail] |

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### Safety and Effectiveness Information

Intended Uses:

BeyondImage Workstation is a software application that is used for viewing medical images. Bevondlmage Workstation receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and digital radiographic devices). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Taking that users may perform when viewing images include, but are not limited to adjustment of window width and center; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images, it also provides standard Multi-Planar Reconstruction (MPR) views Curved-Planar Reconstruction (CPR) views and 3D views of Volume Rendering for digital images from CT, MR, and PET unit. In addition, using BevondImage Workstation, users can edit and print report.

Beyondlmage Workstation cannot display and process mammograms.

Typical users of BeyondImage Workstation are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

Device Description:

BeyondImage Workstation is a software application that provides image viewing and manipulation in a diagnostic imaging setting. The functions of this application are applied to medical images that are acquired and stored on an image server in DICOM format. Beyondlmage Workstation can also transfer images in DICOM 3.0 format over a medical imaging network, as well as exporting images to applications in other proprietary formats.

Predicate Device:

K092235 : BeyondImage Workstation 1. 0 K060505 : Barco Voxar 3D 6.1

> . ::: .

Statement of Substantial Equivalence:

The BeyondImage Workstation 2.0is comparable and substantially equivalent to the Beyondlmage Workstation 1.0(K092235) and the Barco Voxar 3D 6.1 (K060505).

BeyondImage Workstation 2.0, BeyondImage Workstation 1.0and Barco Voxar 3D 6.1 are all available as "software only" application that run under Microsoft Windows operating systems on readily available computer hardware. All applications include image and report viewing and a set of imaging measurements and manipulation tools. All three are DICOM compliant systems capable of receiving and storing images and moving imaging studies using DICOM Query/Retrieve.

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The Beyondlmage Workstation 2.0 and the Beyondlmage Workstation 1.0 share similar technological specifications. Both of them support DICOM protocol for communication of images with other medical imaging devices, and they both provide the functions such as adjustment of window width and center; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images etc. Furthermore, they both provide standard Multi-Planar Reformation (MPR) views and 3D views of Volume Rendering.

The Beyondlmage Workstation 2.0has the similar technological characteristics with the Barco Voxar 3D 6.1. Both of them support DICOM protocol for communication of images with other medical imaging devices, and they both provide the functions such as adjustment of window width and center, scout line, annotation and measurement of regions of interest; and inversion, rotation, and flips of images etc. Furthermore, they both provide function ofCurved-Planar Recontruction(CPR) ..

According to the comparison based on the requirements of 21.CFR 807.87, we state that these devices are substantially equivalent.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Tian Yuehui Manager of Q&R Department Neusoft Medical Systems, Co., Ltd. No 16, Shiji Road, Hunnan Industrial Area Shenyang, Liaoning, 110179 CHINA

OCT 1 5 2010

Re: K102435

Trade/Device Name: BeyondImage Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 16, 2010 Received: August 26, 2010

Dear Mr. Yuehui:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 dovice 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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/ReportalProblem/default.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/cdrh/industry/support/index.html.

Sincerely yours,

signature

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k)

# Indications for Use Statement

OCT 1 5 2010

510(k) Number: K102435

Device Name: BeyondImage Workstation

Beyondlmage Workstation is a software application that is used for viewing medical images. Beyond mage Workstation receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and digital radiographic devices). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Taking that users may perform when viewing images include, but are not limited to adjustment of window width and center; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images, it also provides standard Multi-Planar Reconstruction (MPR) views, Curved-Planar Reconstruction (CPR) views and 3D views of Volume Rendering for digital images from CT, MR, and PET unit. In addition, using Beyondlmage Workstation, users can edit and print report.

Beyondlmage Workstation cannot display and process mammograms.

Typical users of Beyondlmage Workstation are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

Prescription Use YES (Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

Over-The-Counter Use NO

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF DEEDED)

Concurrence of CDRH, @ffice of Bevice Evan

(Division Sign Off)

510K K102435