Beyondlmage Workstation is a software application that is used for viewing medical images, BeyondImage 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. Tasks 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 Reformation (MPR) views and 3D views of Volume Rendering for digital images from CT, MR, and PET unit. In addition, using BeyondImage 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.

Device Description

Beyondlmage 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.

BeyondImage Workstation cannot receive, display and process the images with non-DICOM3.0 format.

Beyondlmage Workstation cannot display and process mammograms.

AI/ML Overview

The provided 510(k) summary (K092235) for the Neusoft BeyondImage Workstation does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

This 510(k) is a Traditional 510(k), which aims to demonstrate substantial equivalence to a legally marketed predicate device. In such cases, the primary focus is on comparing the new device's intended use, technological characteristics, and performance data (if any) to those of the predicate device(s). The document explicitly states: "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... to legally marketed predicate devices."

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to existing PACS workstations (eFilm Workstation K012211 and Omni-Vue System K073062) rather than presenting a performance study with specific acceptance criteria for the BeyondImage Workstation itself.

To directly answer your questions based only on the provided text, the response would be as follows:

A table of acceptance criteria and the reported device performance:
- Not found in the provided document. The document does not specify quantitative acceptance criteria or report specific performance metrics for the BeyondImage Workstation. It focuses on functional equivalence to predicate devices.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not found. The document does not describe a performance study with a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not found. The document does not describe a performance study with a test set where ground truth was established by experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not found. The document does not describe a performance study with a test set.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a PACS workstation for viewing and manipulating images, not an AI-assisted diagnostic tool. No MRMC study is mentioned or relevant for this type of device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not found. This is a workstation software, not an autonomous algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable/Not found. The document does not describe a performance study requiring ground truth.
The sample size for the training set:
- Not applicable/Not found. This device is a PACS workstation for displaying and manipulating images. It is not an AI/ML device that requires a training set in the typical sense for clinical performance.
How the ground truth for the training set was established:
- Not applicable/Not found. As above, no training set or ground truth establishment is described.

In summary, the provided 510(k) documentation focuses entirely on demonstrating substantial equivalence through a comparison of intended use and technological characteristics with predicate devices, as is common for PACS systems. It does not include information on specific performance acceptance criteria or a dedicated study to meet such criteria.

Summary

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K092235

510(k)

Attachment 1

AUG 0 6 2009

Summary of Safety and Effectiveness

Page 1 of 3

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:

Neusoft

Trade Name:	BeyondImage Workstation
Version Number:	1.0
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
Applicable Standard:	NEMA PS 3.1 - 3.18 (2004), Digital Imaging andCommunications in Medicine (DICOM)
Manufacturer andDistributor:	Neusoft Medical Systems Co., Ltd.No.16,Shiji Road, Hunnan Industrial Area,Shenyang, Liaoning, ChinaPost Code : 110179
Submitter:	Contact : Tian YuehuiTitle : Manager of Quality Management DepartmentTel : 86-24-83660646Fax : 86-24-83660563E-Mail : Tianyh@neusoft.com
Summary prepared : July. 30. 2009

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Page 2 of 3

Safety and Effectiveness Information

Intended Uses:

Beyondlmage Workstation is a software application that is used for viewing medical images. BeyondImage 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. Tasks 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 Reformation (MPR) views and 3D views of Volume Rendering for digital images from CT, MR, and PET unit. In addition, using BeyondImage Workstation, users can edit and print report. BeyondImage 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 cannot receive, display and process the images with non-DICOM3.0 format.

Beyondlmage Workstation cannot display and process mammograms.

Predicate Device:

K012211 : eFilm Workstation K073062 : Omni-Vue System

Statement of Substantial Equivalence:

The Beyondlmage Workstation is comparable and substantially equivalent to the eFilm Workstation (K012211) and the Omni-Vue System (K073062).

Beyondlmage Workstation, eFilm Workstation and Omni-Vue System 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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Page 3 of 3

The BeyondImage Workstation and the eFilm Workstation 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 has the similar technological characteristics with the Omni-Vue System. 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 functions to edit and print report.

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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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

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

Neusoft Medical Systems Co., Ltd. % Mr. Tamas Borsai Division Manager TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

AUG 0 6 2009

Re: K092235

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: July 21, 2009 Received: July 23, 2009

Dear Mr. Borsai:

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. Iisting 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 (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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm fars the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Lamme M. Monul

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k)

Attachment 2

Indications for Use Statement

092235 510(k) Number:

Device Name: BeyondImage Workstation

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) Over-The-Counter Use NO

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

ten

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number

Regulation Number and Section

§ 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).