CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM

K042221 · Barco NV Barcoview · LLZ · Dec 30, 2004 · Radiology

Device Facts

• Record ID: K042221
• Device Name: CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
• Applicant: Barco NV Barcoview
• Product Code: LLZ · Radiology
• Decision Date: Dec 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The Coronis 5MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images, including digital mammography, for review by trained medical practitioners.

Device Story

Coronis 5MP is a digital image display system; provides high-resolution visualization of medical images. Used by trained medical practitioners in clinical settings for review and analysis of digital images, including digital mammography. Device functions as a workstation monitor to display diagnostic-quality images; assists practitioners in clinical decision-making by providing clear visual representation of patient data. Benefits include improved visualization of complex medical imagery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital flat panel display system designed for high-resolution visualization of medical images. Specific materials, energy sources, and software architecture details are not provided in the source document.

Indications for Use

Indicated for trained medical practitioners to display and view digital images, including digital mammography, 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 (K013922)
• Dome CX Digital Flat Panel Display System, Model C5i (K040443)

Submission Summary (Full Text)

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DEC 3 0 2004

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## 510(K) SUMMARY

| Manufacturer: | Barco NV Barcoview<br>Theodoor Sevenslaan 106<br>8500 Kortrijk<br>Belgium |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Ferguson Medical<br>Consultant to Barco NV |
| Contact Information: | Phone: [phone]<br>FAX: [phone] |
| Classification Name: | System, image processing |
| Common/Usual Name: | Image display system, medical image<br>workstation, image monitor/display, and others |
| Proprietary Name: | Coronis 5MP Medical Flat Panel Display System |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Coronis 5MP Medical Flat Panel Display System<br>(K013922), Dome CX Digital Flat Panel Display<br>System, Model C5i (K040443) and others |
| Device Description: | The Coronis 5MP device is a digital image<br>display system |
| Intended Use: | The Coronis 5MP Medical Flat Panel Display<br>System is intended to be used in displaying<br>and viewing digital images, including digital<br>mammography, for review by trained medical<br>practitioners. |
| Technological Characteristics: | The Coronis 5MP device consists of<br>components to provide high resolution<br>visualization of digital images. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 0 2004

Barco NV Barcoview c/o Mr. Frank Ferguson Ferguson Medical 12200 Academy Road NE #931 ALBUQUERQUE NM 87111

K042221 Device Name: Coronis 5MP Medical Flat Panel Display System Regulation Number: 21 CFR 892.2050 Regulatory Class: Class II Product Code: LLZ Dated: December 14, 2004 Received: December 16, 2004

Dear Mr. Ferguson:

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 (Premarket Approval), it may be subject to such 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 this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/dsmaldsmamain.html

Sincerely yours,

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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510(k) Number (If known): K042221

Device Name: Coronis 5MP Medical Flat Panel Display System

Indications For Use:

The Coronis 5MP Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

Prescription Use _ ్ల (Per 21 CFR 801.109)

OR

Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________