DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I

K032202 · Planar Systems, Inc. · LLZ · Aug 1, 2003 · Radiology

Device Facts

• Record ID: K032202
• Device Name: DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I
• Applicant: Planar Systems, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Aug 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™ are intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.

Device Story

DOME CX™ Digital Flat-Panel Display System (Models C2™ and C5i™) consists of high-resolution active matrix liquid-crystal display (AMLCD) monitors. Input received via Digital Visual Interface (DVI) 1.0 from a graphics display controller. System utilizes thin film transistors (TFTs) and cold cathode fluorescent tube (CCFT) backlights to render grayscale medical images. C2 model provides 1200 x 1600 resolution; C5i model provides 2048 x 2560 resolution. Used in clinical environments by physicians or trained medical practitioners for diagnostic and referral review. Optional USB connectivity supports peripherals like keyboards, mice, and calibration tools. Output allows practitioners to visualize digital medical images to support clinical decision-making and patient diagnosis.

Clinical Evidence

Bench testing only. Hazard analysis performed and classified as Minor.

Technological Characteristics

AMLCD panels with TFTs and CCFT backlights. DVI 1.0 interface. C2: 1200 x 1600 resolution; C5i: 2048 x 2560 resolution. External power supply. USB connectivity for peripherals. Non-patient contacting. No life-sustaining function.

Indications for Use

Indicated for trained medical practitioners to display and view medical images for review and analysis.

Regulatory Classification

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

• CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K023341)
• CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K023322)

Submission Summary (Full Text)

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AUG - 1 2003
K032202

PLANAR

## 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:

June 24, 2003

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™<br>Models C2™ and C5i™ |
|-----------------|--------------------------------------------------------------------|
| Common Name: | Picture Archiving Communications System |
| Classification: | 892.2050 |
| Name: | System, Image Processing |

## Predicate Devices: 21 CFR 807. 92(a)(3)

| Device<br>Classification<br>Name | SYSTEM, IMAGE<br>PROCESSING,<br>RADIOLOGICAL | SYSTEM, IMAGE<br>PROCESSING,<br>RADIOLOGICAL |
|----------------------------------|-------------------------------------------------------|-------------------------------------------------------|
| Regulation Number | 892.2050 | 892.2050 |
| 510(k) Number | K023341 | K023322 |
| Device Name | CORONIS 5MP MEDICAL<br>FLAT PANEL DISPLAY<br>SYSTEM | CORONIS 2MP MEDICAL<br>FLAT PANEL DISPLAY<br>SYSTEM |
| Applicant | BARCO NV<br>P.O. BOX 12038<br>LA JOLLA, CA 92039 2038 | BARCO NV<br>P.O. BOX 12038<br>LA JOLLA, CA 92039 2038 |
| Product Code | LLZ | LLZ |

## Device Description: 21 CFR 807 92(a)(4)

The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™ are flat panel hi-resolution LCD monitor systems for displaying gray scale medical images for diagnostic and referral use.

The Displays use active matrix liquid-crystal display (AMLCD) panels that generate lower electro-magnetic emissions and heat, and consume less power than traditional CRT displays. The Displays use a common internal interface controller that connects directly to a common graphics display controller via a Digital Visual Interface (DVI) 1.0 interface. The Displays' Thin Film Transistors (TFTs) control transmissive liquid-crystal elements and use intedrated Cold Cathode Fluorescent Tube (CCFT) backlight systems. The DOME C2 displays two megapixels of data in a portrait or landscape orientation of 1200 x 1600 8-bit pixels. The DOME C5i displays five megapixels of data in a portrait or landscape orientation of 2048 x 2560 8-bit pixels. Both display systems include the LCD

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PLAVAR

display panel, integrated drive electronics, integrated backlight, and an external power supply. Optional connections to USB can provide enhanced system functionality, including kevboard, mouse, and calibration technology.

## Indications for Use: 21 CFR 807 92(a)(5)

The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™ are intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.

Technological Characteristics: 21 CFR 807 92(a)(6)

The device is an image display system consisting of computer software and components. The device does not contact the patient, nor does it control any life sustaining devices. A physician or trained medical practitioner provides ample opportunity for competent human intervention to interpret images and information being displayed.

Conclusion: 21 CFR 807 92(b)(1)

- The new Planar, Inc. DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM, Models . C2™ and C5i™ is substantially equivalent to the predicate devices BARCO NV, CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM™ (K023341) and BARCO NV, CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K023322)
- The new and predicate devices are both 2/5Million Pixel Medical Flat Panel Display . Systems intended to be used in displaying and viewing digital images for review by trained medical practitioners. The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. Any difference 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™, Models C2™ and C5i™ contain 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™, Models C2™ and C5i™ will 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures. The figures are connected and appear to be moving forward.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2003

Planar Systems, Inc.. c/o Ned E. Devine, Jr. Entela®, Inc 3033 Madison Ave., S.E. GRAND RAPIDS MI 49548

Re: K032202

Trade/Device Name: DOME CX" DIGITAL FLAT-PANEL DISPLAY SYSTEM
Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: 90 LLZ Dated: June 24, 2003 Received: July 18, 2003

Dear Mr. Devine:

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 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); 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.

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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103228

Page 1 of -1

(Indications for Use Form)

510(k) Number:

K632202

Device Name:

DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™ from Planar Systems, Inc.

Indications for Use:

The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C2™ and C5i™ are intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF

OR

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ 1:

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

- Nancy C Brogdon

and Radiological Dev 510(k) Number