← Product Code [LLZ](/productcode/LLZ) · K133609 # THE DOME S6C (K133609) _Nds Surgical Imaging · LLZ · Feb 28, 2014 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K133609 ## Device Facts - **Applicant:** Nds Surgical Imaging - **Product Code:** [LLZ](/productcode/LLZ.md) - **Decision Date:** Feb 28, 2014 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use The Dome Sx line, model S6c is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners. Model Dome S6c is not intended for mammography use. ## Device Story The Dome S6c is a 30-inch, 6-megapixel widescreen color monitor designed for clinical review and analysis of medical images from multiple modalities. It functions as a single-unit replacement for dual 3MP display configurations. The device receives digital video input via a DVI dual-channel connector from a workstation. It features an integrated 'RightLight' controller that monitors and stabilizes backlight luminance, and a 'RightCheck' front sensor for automated quality assurance. The monitor is intended for use by trained medical practitioners in clinical environments. By providing a bezel-free, high-resolution, high-brightness display, it facilitates the viewing of complex medical imagery, aiding clinicians in diagnostic review and decision-making. ## Clinical Evidence Bench testing only. The device was evaluated for safety and performance against IEC/EN 60601-1 and 60601-1-2 standards. No clinical data was required or provided. ## Technological Characteristics 30-inch diagonal, 6MP (3280 x 2048) color LCD; pixel pitch 0.197mm; 1000:1 contrast ratio; 800 cd/m² brightness. Features integrated RightLight backlight stabilization and RightCheck front sensor for QA. Includes PCI Express graphics board for dual-link connectivity. Supports 10/12-bit look-up tables. Connectivity via DVI dual-channel. Power: 100-240 VAC. Standards: IEC 60601-1:2005, EN 60601-1-2:2007. ## 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 - Dome C3 color ([K032638](/device/K032638.md)) ## 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}------------------------------------------------ NDS SURGICAL · IMAGING K133609 Page 1 of 3 # 510(K) SUMMARY - A. Manufacturer: NDS Surgical Imaging, LLC 5750 Hellyer Avenue San Jose, CA 95138 USA - B. Submitted By: Jim Leng Regulatory Engineer/NDS Surgical Imaging, LLC November 15, 2013 Revision: January 29, 2014 Revision: February 20, 2014 > 408-776-0085 408-776-9878 The Dome® S6c monitor Picture Archiving Communication System System, Image Processing, Radiological Bl, Address: NDS Surgical Imaging, LLC 5750 Hellyer Avenue San Jose, CA 95138 USA C. Date of Preparation: - D. Contact Information: E. Classification: F. Common Name: G. Proprietary Name: - H. Classification Number: 21 CFR 892.2050 - I Product Code: LLZ Tel: Fax: Dome model S6c is substantial equivalent to the predicate device K032638 J. Substantial Equivalence: Dome model C3 color. Both devices have the same indication for use with the same characteristics. Dome model S6c series is a 6MP display device, equivalent to the resolution of dual 3MP radiology displays. Both devices have the same viewing angle, number of colors and utilize the same backlight stabilization and calibration technologies. The physical size difference does not impact display information and viewing. - K. Device Description: The Dome model S6c is a widescreen 30-inch 6 megapixel color monitor. Its sleek design, high brightness and bezel free separation between two 3MP displays makes Dome model S6c ideal for read of patient images acquired from multiple medical imaging modalities. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for NDS Surgical Imaging. The logo consists of a grid of squares on the left, followed by the letters "NDS" in bold, sans-serif font. Below the letters, the words "SURGICAL IMAGING" are printed in a smaller font size. | L. Intended Use: | The Dome Sx line, model S6c is intended to be used in displaying and
viewing medical images for review and analysis by trained medical
practitioners. | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Model Dome S6c is not intended for mammography use. | | M. Technological Characteristics: | Bezel-free framing of 6 megapixels of data is presented in a 30 inch
diagonal display landscape format with resolution of 3280 x 2048 and a
pixel pitch of 0.197mm. The integrated Dome RightLight Controller
monitors and stabilizes backlight luminance. The display unit includes a
PCI Express graphics board to support the required dual-link connectivity
for the display. | | Characteristic Items | Predicate device K032638 | Specification K 133609 | |----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The DOME CX ™DIGITAL FLAT-
PANEL DISPLAY SYSTEM™,
Model C3 Color™ and C3 Gray are
intended to be used in displaying and
viewing medical images for review
and analysis by trained medical
practitioners. | Dome Sx line, model Dome S6c is
intended to be used in displaying and
viewing medical images for review
and analysis by trained medical
practitioners. | | Screen | | | | Screen diagonal | 20.8" Diagonal (528 mm) | 30" Diagonal (762 mm) | | Resolution | 1536 x 2048 pixels (portrait)
2048 x 1536 pixels (landscape) | Dual 1536 x 2048 pixels (portrait)
(Note: future implementation)
Dual 1640 x 2048 pixels (portrait)
3280 x 2048 pixels (landscape) | | Pixel pitch | 0.207 mm | 0.197 mm | | Contrast ratio | 600:1 - typical | 1000:1 - typical | | Brightness | 235 cd/m² typical | 800 cd/m² typical | | Pixel rise/fall time | 50 ms | 30 ms typical | | Viewing angle (CR
10:1) | +/- 85° (170°) horizontal
+/- 85° (170°) vertical | +/- 85° (170°) horizontal
+/- 85° (170°) vertical | | Viewing
Characteristics | | | | Stabilization,
calibration, and
automated QA | Built in RightLight rear sensor for
backlight stabilization.
Factory calibrated.
QA through manual external
photometer | Built in RightLight rear sensor for
backlight stabilization.
Factory calibrated.
QA through embedded RightCheck
front sensor and manual external
photometer | | Characteristics | | | | Look up table | 10/12 bit | 10/12 bit | {2}------------------------------------------------ Image /page/2/Picture/6 description: The image shows the logo for NDS Surgical Imaging. The logo consists of a grid of circles and squares on the left, followed by the letters "NDS" in bold, sans-serif font. Below the letters, the words "SURGICAL - IMAGING" are written in a smaller, sans-serif font. Image /page/2/Picture/1 description: The image shows handwritten text on a white background. The text "K133609" is at the top, followed by "Page 3 of 3" below it. The handwriting is cursive and slightly stylized, with the numbers and letters clearly legible. | Interface | | | |-----------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------| | Digital Video Input | 1x DVI Revision 1.0 single channel
connector | 1x DVI Revision 1.0 digital dual-
channel connector | | Input Formats | | | | Landscape Orientation | 2048x1536 (8 bits per pixel, 24 bit
color) | 3280x2048 (8 or 10 bit per pixel, 24
bit or 30 bit color) | | Portrait Orientation | 1536x2048 (8 bits per pixel, 24 bit
color) | 2x 1536x2560 or 2x 1640x2048 (8 or
10 bit per pixel, 24 bit or 30 bit color) | | Power Requirements | | | | Power Supply | 100~240 VAC 50~60Hz | 100~240 VAC 50~60Hz Universal
Auto Switching with Medical
Approvals and PFC | | Regulatory Approvals | | | | Safety | EN 60601-1 Part 1. General requirements
for safety | IEC 60601-1: 2005 | | EMI | EN 55011 Class B | EN 60601-1-2: 2007 | # N. Conclusion: Based upon our test results, the Dome model S6c radiology display meets IEC/EN60601-1 and 60601-1-2 standards which establish its safe design and operation. The Dome model S6c and the predicate device model C3 color are identical in terms of indication for use, characteristics, specifications and performance. The difference is Dome model S6c is one package that replaces two Dome model C3 color side by side displays in use. {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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized lines representing its wings and body. The logo is black and white. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 28, 2014 NDS Surgical Imaging, LLC % Mr. Jim Leng Regulatory Engineer 5750 Hellyer Avenue SAN JOSE CA 95138 Re: K133609 Trade/Device Name: The Dome® S6c Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 5, 2014 Received: February 6, 2014 Dear Mr. Leng: 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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 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-Mr. Leng If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm. 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/MedicalDevices/Safety/ReportaProblem/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/MedicalDevices/ResourcesforYou/Industry/default.bum. Sincerely yours, ொ Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K133609 Device Name The Dome S6c Color Monitor Indications for Use (Describe) Dome Sx line, model Dome S6c is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners. Model Dome Soc is not intended for mammography use. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) لـ Over-The-Counter Use (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ## FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Sm.h.7) This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." --- **Source:** [https://fda.innolitics.com/device/K133609](https://fda.innolitics.com/device/K133609) **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