CORONIS 3MP-21 AND MFGD 3621

K052429 · Barcoview · LLZ · Sep 15, 2005 · Radiology

Device Facts

• Record ID: K052429
• Device Name: CORONIS 3MP-21 AND MFGD 3621
• Applicant: Barcoview
• Product Code: LLZ · Radiology
• Decision Date: Sep 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The Coronis 3MP-21" is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

Device Story

Coronis 3MP-21" is a medical display system for viewing digital images; consists of 21.3" grayscale LCD (MFGD 3621), high-resolution display controller board (BarcoMed Coronis), and MediCal Pro QA software. System operates as single or multi-head configuration; connects to PACS workstation. MediCal Pro software automates image quality assurance, logs performance, and manages calibration. Used by trained medical practitioners in clinical environments for image review; not for primary mammography diagnosis. System provides 10-bit grayscale output for diagnostic viewing. Benefits include standardized image quality and automated maintenance of display performance.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

21.3" grayscale LCD display (MFGD 3621); 2048 x 1536 pixel resolution; 10-bit display controller board with 10-bit LUT (1024 gray levels); MediCal Pro software for automated QA/calibration; landscape/portrait orientation support.

Indications for Use

Indicated for trained medical practitioners to display and view digital images for review. Contraindicated for primary image diagnosis in mammography.

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 3MP Medical flat panel display system (K013922)
• MFGD 2320 20-inch 2 Megapixel grayscale display (K033004)

Submission Summary (Full Text)

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#### 510(k) Summary In accordance with 21 CFR 807.92

K052429

# 1. Date of preparation

SEP 1 5 2005

September 01, 2005

# 2. Company information

BarcoView 35 President Kennedypark B-8500 Kortrijk, Belgium Tel. [phone] Fax [phone]

# 3. Contact person

Lieven De Wandel Official correspondent

#### 4. Device information

- Trade name: Coronis 3MP-21" .
- Common name: Display system, medical image workstation, and others ●
- Classification name: System, Image Processing .
- Classification number: 21 CFR 892.2050 / Procode 90LLZ .

#### 5. Predicate device

- Name: Coronis 3MP Medical flat panel display system .
- 510(k) number: K013922 .
- Manufacturer: Barco NV .

#### 6. Device description

Coronis 3MP-21" is a display system for medical viewing. It consists of 3 components:

MFGD 3621 is a 21.3" grayscale LCD display. BarcoMed Coronis is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal Pro is user-friendly softcopy QA software.

The display system can be a single-head system or multi-head system. In the last case it -ontains multiple displays and display controller boards.

# 7. Intended use

"The Coronis 3MP-21" is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

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# 8. Summary of technological characteristics

The device consists of three components:

- One 3-megapixel flat panel display (MFGD 3621) .
- One 10-bit display controller board (BarcoMed Coronis) .
- MediCal Pro software .

The flat panel display has a resolution of 2048 x 1536 pixels. It can be used in landscape and portrait mode.

The display controller board is an ultra-high speed board with a 10-bit in, 10-bit out look-up table, providing 1024 simultaneous levels of gray.

The MediCal Pro software provides fully automated image quality assurance. It maintains and logs display viewing performance, automates QA tasks and sets up system calibration.

Compared to the predicate device, the display of the Coronis 3MP-21" system has a different LCD panel with somewhat larger screen size. The other components of the system are the same.

The device does not come into contact with the patient. It does not control any life sustaining devices either.

# 9. Conclusion:

The Barco Coronis 3MP-21" is substantially equivalent to the predicate device, Coronis 3MP Medical flat panel display system.

The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use.

Any difference between both devices does not affect safety or efficacy.

The 510(k) Pre-Market Notification for the Barco Coronis 3MP-21" contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

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#### 510(k) Summarv In accordance with 21 CFR 807.92

# 1. Date of preparation

September 01, 2005

# 2. Company information

BarcoView 35 President Kennedypark B-8500 Kortrijk, Belgium Tel. [phone] Fax [phone]

# 3. Contact person

Lieven De Wandel Official correspondent

# 4. Device information

- . Trade name: MFGD 3621
- . Common name: Display system, medical image workstation, and others
- Classification name: System, Image Processing .
- . Classification number: 21 CFR 892.2050 / Procode 90LLZ

# 5. Predicate device

- Name: MFGD 2320 20-inch 2 Megapixel grayscale display .
- . 510(k) number: K033004
- . Manufacturer: Barco NV

# 6. Device description

MFGD 3621 is a 21.3" grayscale LCD display for medical viewing. It is combined with MediCal Pro, a user-friendly softcopy QA software.

# 7. Intended use

The MFGD 3621 is intended to be used in displaying and viewing digital images for review by crained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

# 8. Summary of technological characteristics

The flat panel display has a resolution of 2048 x 1536 pixels. It can be used in landscape or

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The MediCal Pro software provides fully automated image quality assurance. It maintains and logs display viewing performance, automates QA tasks and sets up system calibration.

Compared to the predicate device, the MFGD 3621 display has a different LCD panel with larger screen size and higher resolution.

The device does not come into contact with the patient. It does not control any life sustaining devices either.

# 9. Conclusion:

The Barco MFGD 3621 is substantially equivalent to the predicate device, MFGD 2320 20-inch 2 Megapixel grayscale display.

The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use.

Any difference between both devices does not affect safety or efficacy.

The 510(k) Pre-Market Notification for the Barco MFGD 3621 contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines.

#### Public Health Service

# SEP 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Lieven De Wandel Official Correspondent BarcoView - Medical Imaging Systems President Kennedypark 35 B-8500 Kortrijk BELGIUM

Re: K052429 Trade/Device Name: Coronis 3MP-21" and MFGD 3621 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 1, 2005 Received: September 8, 2005

#### Dear Mr. De Wandel:

.

. .

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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

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

2 Enclosures

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# INDICATIONS FOR USE

-10(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Coronis 3MP-21"

Indications for Use:

"The Coronis 3MP-21" is intended to be used in displaying and viewing digital images for review The Coronis SF15 15 meenage to se sevices must not be used in primary image diagnosis in mammography.

Prescription Use __XX__

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Braydon

(Division Sign Division of Reproduc and Radiological Devic 510(k) Number

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# INDICATIONS FOR USE

10(k) Number (if known): קבע 52429 -----------------------------------------------------------------------------------------------------------------------------------------

Device Name: MFGD 3621

Indications for Use:

"The MFGD 3621 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _

(21 CFR 801 Subpart C)

.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Boydon
(Division Sign-Off)

Division of Reproduc and Radiological Devices 510(k) Number