← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K083910 # VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER (K083910) _Vidistar, LLC · LLZ · Apr 15, 2009 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K083910 ## Device Facts - **Applicant:** Vidistar, LLC - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Apr 15, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device ## Intended Use The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard "off-the-shelf" personal computers, business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet. All quantitative data ranges are derived from the clinical experience of laboratories and are included in observation libraries for VidiStar users. VidiStar strongly recommends that users review these ranges with their individual diagnostic needs in mind prior to using the VidiStar PACS & DICOM Viewer Software system for clinical reporting. The VidiStar PACS & DICOM Viewer Software system should not be used for reviewing full-field digital mammograms. ## Device Story VidiStar PACS & DICOM Viewer is a software-based system for managing, displaying, and analyzing medical images. It accepts DICOM and non-DICOM data from various OEM imaging modalities. The system operates on standard off-the-shelf PCs and servers, enabling remote access via the Internet. Physicians and clinicians use the software to organize images, perform digital manipulations, conduct quantitative measurements, and generate DICOM structured reports. Quantitative data ranges are sourced from laboratory clinical experience and stored in observation libraries. The device facilitates clinical decision-making by providing centralized access to diagnostic images and reports. It benefits patients by enabling efficient image management and remote clinical review. ## Clinical Evidence No clinical data. The submission relies on bench testing, including validation planning, alpha testing, and beta testing to demonstrate software performance and safety. ## Technological Characteristics Software-based PACS running on standard off-the-shelf PCs and servers (Windows/Linux). Supports DICOM and non-DICOM data formats. Connectivity via TCP/IP over the Internet. Features include image manipulation, quantitative measurement, and structured reporting. Designed in accordance with DICOM standards. ## Regulatory 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 - Heartlab, Inc Ascentia (formally Encompass) - Agfa Corp. Impax - Philips Inturis Suite ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 16083910 7 #### Section E: 510K Summary ## Submitter VidiStar, LLC P.O. Box 8539 Greenville, SC 29604 Phone: 864.979.1767 Fax: 864.232.1218 (call prior to transmission) ## Contact Person Craig A. Walker, MHA VidiStar, LLC Tel: 512.797.1910 Tel: 864.979.1767 Fax: 864.232.1218 (call prior to transmission) #### Date Prepared 28 November 2008 ## Software Information | Trade Name: | VidiStar PACS & DICOM Viewer Software | |----------------------|---------------------------------------------------------------------------------------------------------------------------| | Common Name: | - Picture Archiving and Communications Software System
- Digital Imaging and Communications in Medicine (DICOM) Viewer | | Classification Name: | - System, Image Processing, Radiological
- Computer, Diagnostic, Programmable | - System, Digital Image Communications, Radiological ## Device Description The VidiStar PACS & DICOM Viewer Software System is a picture archiving and communications system software used to process, display, transfer, enable reports, communicate, store and archive digital medical images using Transmission Control Protocol/Internet Protocol (TCP/IP). It supports DICOM structured reports for creating, rendering, storage and archiving. ## Indications For Use: The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard "off-the-shelf" personal computers, {1}------------------------------------------------ business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet. All quantitative data ranges are derived from the clinical experience of laboratories and are included in observation libraries for VidiStar users. VidiStar strongly recommends that users review these ranges with their individual diagnostic needs in mind prior to using the VidiStar PACS & DICOM Viewer Software system for clinical reporting. The VidiStar PACS & DICOM Viewer Software system should not be used for reviewing full-field digital mammograms. ### General Safety and Effectiveness Concerns The device labeling and manual provide operating instructions for the safe and effective use of VidiStar PACS & DICOM Viewer Software. The display, storage, retrieval, and analysis of information provide a minor level of hazard concern. #### Standard: The VidiStar PACS & DICOM Viewer Software system is designed in accordance with product safety and performance requirements set forth in the following standard: - 1. Digital Imaging and Communications in Medicine (DICOM) ## Summary of Design Control Activities: The design control activities used by VidiStar for software design and testing included the following quality assurance design control measures applied to the development of the VidiStar PACS & DICOM Viewer Software product: - 7. Validation Planning - 8. Testing Phase - 9. ALPHA Testing - 10. BETA Testing - 11. Software Enhancements - 12. Software Release Version Number #### Substantial Equivalence VidiStar PACS & DICOM Viewer Software is substantially equivalent to the 510(k) PACS products that are currently on the market. While there are some feature differences between the VidiStar device and the equivalent devices, these differences do not affect the safety or effectiveness of the new device. The VidiStar PACS & DICOM Viewer Software product includes additional medical disciplines which utilize DICOM and non-DICOM medical imaging standards. The VidiStar PACS & DICOM Viewer Software image viewer is a generic DICOM viewer that can operate over the Internet. This flexibility contributes to the effectiveness of the device, without compromising the safety. The VidiStar PACS & {2}------------------------------------------------ DICOM Viewer Software is substantially equivalent to the following picture archiving and communications devices: | Feature | Heartlab, Inc
Ascentia
(formally
Encompass) | Agfa Corp.
lmpax | Philips
Inturis
Suite | VidiStar PACS &
DICOM Viewer
Software | |---------------------|------------------------------------------------------|---------------------|-----------------------------|---------------------------------------------| | Operating
System | Windows
NT/2000/2003/XP | Windows NT | Windows
NT | Linux and Windows
2000/XP | | lmage
Source | DICOM | DICOM | DICOM | DICOM | | Display
Rates | Over 30 fps | Over 30 fps | Over 30 fps | Over 30 fps | | Multiple
Windows | Yes | Yes | Yes | Yes | | lmage
Export | bmp, jpg, mpg | bmp,jpg,mpg | bmp,jpg,avi | bmp, jpg, png, avi | | Network
Access | Yes | Yes | Yes | Yes | | Analysis | Yes | Yes | Yes | Yes | | Reporting | Yes | Yes | Yes | Yes | # Conclusions With VidiStar PACS & DICOM Viewer Software digital medical images, from virtually any DICOM and non-DICOM digital imaging modality available today, can be processed, reviewed, measured, analyzed, reported, stored, and archived onto a server. The software can read DICOM images and most non-DICOM images, and allows for remote access to the PACS server's data via the Internet. {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 circular seal with the text "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 stylized lines. # DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # APR 1 5 2009 Mr. Craig A. Walker, MHA Partner VidiStar, LLC P.O. Box 8539 GREENVILLE SC 29604-8539 Re: K083910 · Trade/Device Name: VidiStar® PACS & DICOM Viewer Server Software System Regulation Number: - 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 9, 2009 Received: March 11, 2009 Dear Mr. Walker: 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. 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 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. {4}------------------------------------------------ Page 2 If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter. | 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 | |----------------|----------------------------------|----------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 | | 21 CFR 892.xxx | (Radiology) | (240) 276-0120 | | Other | | (240) 276-0100 | 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/. 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, Lois M. Morris Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Section D: Indications For Use Applicant: VidiStar, LLC K083910 510(k) Number (if known): Device Name: VidiStar® PACS & DICOM Viewer Server Software System #### Indications For Use: The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard "off-the-shelf" personal computers, business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet. All quantitative data ranges are derived from the clinical experience of laboratories and are included in observation libraries for VidiStar users. VidiStar strongly recommends that users review these ranges with their individual diagnostic needs in mind prior to using the VidiStar PACS & DICOM Viewer Software system for clinical reporting. The VidiStar PACS & DICOM Viewer Software system should not be used for reviewing full-field digital mammograms. |--|--|--| CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices | | | |----------------------------------------------------------------------------------|---------|--| | 510(k) Number | K083910 | | | Prescription Use X | Or | Over-the-counter Use | |--------------------|----|----------------------| |--------------------|----|----------------------| scription Use X (Per 21 CFR 801.109) 10 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K083910](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K083910) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com