BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM

K041508 · Barco NV Barcoview · LLZ · Aug 27, 2004 · Radiology

Device Facts

• Record ID: K041508
• Device Name: BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM
• Applicant: Barco NV Barcoview
• Product Code: LLZ · Radiology
• Decision Date: Aug 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The Coronis 5MP HD device is intended to be used in displaying and viewing digital images for review by trained medical practitioners. It is especially designed for digital mammography applications.

Device Story

Coronis 5MP HD is a high-resolution diagnostic display system. It receives digital image data from medical imaging systems; transforms data into visual output for clinical review. Used in clinical settings by trained medical practitioners; output facilitates diagnostic decision-making for digital mammography. Device provides high-resolution visualization of medical images to support clinical assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

High-resolution medical flat panel display system; electronic capabilities for high-resolution image evaluation; intended for diagnostic use.

Indications for Use

Indicated for trained medical practitioners to display and view digital images, specifically for digital mammography applications.

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)

Submission Summary (Full Text)

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KD4-1508

AUG 2 7 2004

## 510(K) SUMMARY

| Manufacturer: | Barco NV Barcoview<br>Theodoor Sevenslaan 106<br>8500 Kortriik<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, monitor, display and others |
| Proprietary Name: | Coronis 5MP HD |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Coronis 5MP Medical Flat Panel Display System<br>(K023341) |
| Device Description: | The Coronis 5MP HD is a diagnostic display |
| Intended Use: | The Coronis 5MP HD device is intended to be<br>used in displaying and viewing digital images<br>for review by trained medical practitioners. It<br>is especially designed for digital mammography<br>applications |
| Technological Characteristics: | The Coronis 5MP HD device is a high resolution<br>monitor with electronic capabilities for<br>evaluation of high resolution medical images |

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Image /page/1/Picture/13 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized image of an eagle. The eagle is depicted with its wings spread, symbolizing protection and care. The seal is printed in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 27 2004

Barco NV Barcoview % Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road NE #931 ALBUQUERQUE NM 87111

Re: K041508

Trade/Device Name: CORONIS 5MP HD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: July 20, 2004 Received: July 30, 2004

Dear Mr. Ferguson:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cherosary to regary activent date of the Medical Device Aments, or to conimeres prior to may 20, 1976, the example with the provisions of the Federal Food, Drug, devices that have occh reculise in accoreapproval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of gencrar controls provisions proctice, 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 If your device is bassilled (100 to 10) mls. Existing major regulations affecting your device can inay be subject to subli additional oblines, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obas acements 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 that I 1771 has made a decertres and regulations administered by other Federal agencies. You must comply or any i cocrar statures and regalations and limited to: registration and listing (21 CFR Part with an the Act 3 requirements, measurements as set for the requirements as set forth in the our); abounding (IT CFR Part 820); and if applicable, the electronic product qualiny Bysents (Sections (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) Frass lotter than will your to FDA finding of substantial equivalence of your device to a legally promance noticated 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 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

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510(k) Number (If known):

Device Name: Coronis 5MP HD

Indications For Use:

The Coronis 5MP HD display is intended to be used in displaying and viewing digital images for review and displaying and viewing argical practitioners. It is specifically designed for digital mammography applications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Legarra

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

Prescription Use _ XX (Per 21 CFR 801.109)