DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I

{0}------------------------------------------------ КОНО443 #### JUN 1 6 2004 400 Fifth Avenue, Waltham, MA 02451-8738, USA Phone: +1-781-895-1155 Fax: +1-781-895-1133 www.planar.com ## 510(k) Summary of Safety and Effectiveness This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990. Date Prepared: January 19, 2004 Submitter's Information: 21 CFR 807.92(a)(1) Planar Systems, Inc. 400 Fifth Ave. Waltham, MA 02451-8738 USA Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) | Trade Name: | DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM | |-----------------|--------------------------------------------| | | Model C5i™ | | Common Name: | Mammographic X-ray System | | Classification: | 892.1710 | | Name: | System, Image Processing | Predicate Devices: 21 CFR 807. 92(a)(3) | Device | SYSTEM, IMAGE | |-------------------|-----------------------------------------------------------------| | Classification | PROCESSING, | | Name | RADIOLOGICAL | | Regulation Number | 892.2050 | | 510(k) Number | K032202 | | Device Name | DOME CX™ DIGITAL FLAT-<br>PANEL DISPLAY SYSTEM™,<br>Model C5i™ | | Applicant | Planar Systems, Inc.<br>400 Fifth Ave<br>Waltham, MA 02451-8738 | | Product Code | 90 LLZ | Device Description: 21 CFR 807 92(a)(4) The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Model C5i™ is a flat panel hi-resolution LCD monitor system for displaying gray scale medical images for diagnostic and referral use. The Displays use active matrix liquid-crystal display (AMLCD) panels that generate lower The Displays use active maths liquit aryonal and consume less power than traditional CRT displays. The Displays use a common internal interface controller that connects directly displays - The Dioplay controller via a Digital Visual Interface (DVI) 1.0 interface. to a common graphios arepray stors (TFTs) control transmissive liquid-crystal elements {1}------------------------------------------------ and use integrated Cold Cathode Fluorescent Tube (CCFT) backlight systems The and use miegrated Cold Cathodo Flabroom 7 Section 1 Section of 2018 DOME CSI uisplays five megapixolo of cattle LCD display panel, integrated drive x 2500 o-bit pixers. The system mora an external power supply. Optional connections to electronics, megrated backlight, and an oxlority, including keyboard, mouse, and calibration technology. #### Indications for Use: 21 CFR 807 92(a)(5) The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Model C5i™ is intended to be displaying and viewing radiographs of the breast for review and analysis by trained medical practitioners. #### Technological Characteristics: 21 CFR 807 92(a)(6) oglour one is an image display system consisting of computer software and components. The device is an image uisplay byotont bonoloing or control any life sustaining devices. A The device does not contact the pation, nor ides ample opportunity for competent human intervention to interpret images and information being displayed. Conclusion: 21 CFR 807 92(b)(1) - John 21 OF C OF C OF C ( ) DIGITAL FLAT-PANEL DISPLAY SYSTEM, Model . C5i™ is substantially equivalent to the predicate device, DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM, Model C5i™. - The new and predicate devices are both 5Million Pixel Medical Flat Panel Display . The hew and predicate do need in be displaying and viewing radiographs for review and Systems intendod to be acou in title new device and predicate devices are analysis by trainou mot in the areas of technical characteristics, general function, substantially cquivalent in the arous ofference between the two devices does not affect safety or efficacy. - The 510(k) Pre-Market Notification for the DOME CX™ DIGITAL FLAT-PANEL DISPLAY . SYSTEM™, Model C5i™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate devices. - The Planar Systems, Inc., DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, . 11:01 tarar e your be manufactured by in accordance with voluntary and safety standards. - The submission contains the results of a hazard analysis and the potential hazards have . been classified as Minor. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### JUN 1 6 2004 Dome Imaging Systems, Inc. % Mr. Ned Devine Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548 Re: K040443 18-16-11-15 Trade/Device Name: DOME™ CX Digital Flat-Panel Display System™ Model C5iTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: May 27, 2004 Received: June 1, 2004 Dear Mr. Devine: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > Po(x) premainted in equivalent (for the indications referenced above and nave uctering a the actived predicate devices marketed in interstate for use stated in the encrosure, to regally manatiment date of the Medical Device Amendments, or to commerce prof 10 May 28, 1976, the enactined with the provisions of the Federal Food, Drug, devices that have been reclassined in according approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a premarket af the and Cosment Act (Act) that do not require appro the general controls provisions of the Act. The You may, therefore, market the device, subject to include registration, listing of general controls provisions of the Act include requirements for any and general controls provisions of the rice nellations against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classined (see above) mio existing major regulations affecting your device can may be subject to such additional controls. Existing major regulation FDA mo may be subject to such additional controller Litter & Parts 800 to 898. In addition, FDA may be found in the Code of Poderal England Stages in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a saccession of the requirements of the Act of the Act one mate agempl that FDA has made a determination had your do to received agencies. You must comply or any Federal statutes and regulations administered by other Federal and CEP Pat or any Federal statures and regulations administration and listing (2) CFR Patt (2) CFR Patt with all the Act STequirements, melaaning, out her man and manufacturing as set forth in the 807), labeling (21 CFR Part 001), good handler and if applicable, the electronic product quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1000-1060 quality Systems (QS) regalation (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) In a legally This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The PDA inding of subsition 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 Part 801), please r the same of the same of a to a transmall on the same on the regulation If you desire specific advice for your device on our last ling ages on the regulation number at the top of the letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotive and the regulation entitled, "Misbranding Office of Compliance at (301) 594-4639. Also, please of their . Other accepted Office of Compliance at (301) 374-1057. This, pressed 377) you may obtain. Other general by reference to premarket nonmeanon - (Dr of Act may be obtained from the Division of Shall information on your responsionities and its toll-free number (800) 638-2041 or Manufacturers, International and Ochounter one of the courted.html dsmamain.html. Sincerely yours, Nancy C. Brydon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K040443 Device Name: Device Name. DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Model C5i™ from Planar Systems, Inc. Indications For Use: The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Model C5¡™ is The DOME OX - Dictirite Feing and viewing radiographs of the breast for intended to be boos by trained medical practitioners. Prescription Use __________________ ANB/OR Over-The-Counter Use ______________________________________________________________________________________________________________ | Tooonption 01 Subpart D) (21 CFF 807 Subpart C) (Part 21 CFR 801 Subparto) (21 OF Froof Subjar 0) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concyrrence of CDRH, Office of Device Evaluation (ODE) Luvila Segura Page 1 of 1 (Division Sign-Cit) Division of Reproductive, Abdominal, and Radiological Device 510(k) ! Number