(14 days)
Not Found
No
The summary describes standard image viewing and manipulation functions typical of a PACS workstation and does not mention any AI or ML capabilities.
No
The device is a software application for viewing and manipulating medical images for diagnostic purposes, not for treating any condition or ailment.
Yes.
The device description states "Beyondlmage Workstation is a software application that provides image viewing and manipulation in a diagnostic imaging setting." Additionally, its users are "trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others," who would use it within a diagnostic workflow.
Yes
The device is explicitly described as a "software application" and its functions are applied to medical images. There is no mention of accompanying hardware that is part of the device itself.
Based on the provided information, the BeyondImage Workstation is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The BeyondImage Workstation's intended use is to view, process, and display medical images acquired from imaging modalities like CT, MR, US, etc. These are images of the body itself, not specimens taken from the body.
- The description focuses on image manipulation and display. The tasks listed (window adjustment, stacking, annotation, measurement, MPR, 3D views) are all related to the visual interpretation and analysis of medical images.
- There is no mention of analyzing biological samples or performing tests on bodily fluids or tissues.
Therefore, the BeyondImage Workstation falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, US, RF units, computed and digital radiographic devices, PET unit
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
:
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 and |
| Communications in Medicine (DICOM) | |
| Manufacturer and | |
| Distributor: | Neusoft Medical Systems Co., Ltd. |
| No.16,Shiji Road, Hunnan Industrial Area, | |
| Shenyang, Liaoning, China | |
| Post Code : 110179 | |
| Submitter: | Contact : Tian Yuehui |
| Title : Manager of Quality Management Department | |
| Tel : 86-24-83660646 | |
| Fax : 86-24-83660563 | |
| E-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:
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.
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.
3
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
4
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
5
510(k)
Attachment 2
Indications for Use Statement
092235 510(k) Number:
Device Name: BeyondImage Workstation
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.
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