(50 days)
Not Found
No
The summary describes standard medical image viewing and manipulation functions (windowing, stacking, annotation, MPR, CPR, 3D rendering) and does not mention any AI/ML specific capabilities or performance metrics.
No
The device is a software application for viewing and manipulating medical images for diagnostic purposes, not for applying therapy.
No.
The device is a software application for viewing and manipulating existing medical images, not for generating a diagnosis itself. It supports diagnostic imaging but does not perform the diagnostic function.
Yes
The device is explicitly described as a "software application" and its functions are applied to medical images acquired and stored on an image server. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, the BeyondImage Workstation is not an In Vitro Diagnostic (IVD) 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, as described, is a software application for viewing and manipulating medical images acquired from imaging modalities like CT, MR, US, etc. These images are representations of the internal structure of the body, not specimens taken from the body.
- The intended use and device description clearly focus on image processing and display for diagnostic imaging. The functions described (viewing, manipulation, reconstruction, reporting) are all related to interpreting 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 IVD device.
N/A
Intended Use / Indications for Use
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.
Product codes
LLZ
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.
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
Typically trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others. Diagnostic imaging setting.
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
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).
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Image /page/0/Picture/0 description: The image shows the word "Neusoft" in a bold, sans-serif font. The text is black against a white background. The word is positioned on the left side of the image.
510(k)
Summary of Safety and Effectiveness K102438
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:
| 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 | |
| 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 |
...
page 1 of 3
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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.
: 11. 1 1 .
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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 depiction of an eagle or bird in flight, with three curved lines representing its wings and tail feathers. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
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
4
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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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
5
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