E-2320 PA S

K052529 · Barcoview · LLZ · Sep 30, 2005 · Radiology

Device Facts

• Record ID: K052529
• Device Name: E-2320 PA S
• Applicant: Barcoview
• Product Code: LLZ · Radiology
• Decision Date: Sep 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The E-2320 PA S 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

E-2320 PA S is a 20.1-inch grayscale medical flat panel display; resolution 1600x1200 pixels. Used by trained medical practitioners in clinical settings for viewing digital images. Device includes NioWatch software for display calibration, test pattern generation, and viewing controller information to ensure DICOM-compliant viewing. Operates in landscape or portrait mode. Does not contact patients; does not control life-sustaining equipment. Output is visual display of medical images for clinical review; assists practitioners in diagnostic or review workflows.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

20.1-inch grayscale flat panel display; 1600x1200 pixel resolution. Includes NioWatch software for calibration and DICOM-compliant viewing. Supports landscape and portrait orientation. Non-contact device.

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

• E 2621 (K051902)

Submission Summary (Full Text)

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K05229

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

### 1. Date of preparation

September 09, 2005

SEP 3 0 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: E-2320 PA S .
- . Common name: Medical flat panel display
- . Classification name: System, Image Processing
- . Classification number: 21 CFR 892.2050 / Procode 90LLZ

#### 5. Predicate device

- . Name: E 2621
- . 510(k) number: K051902
- . Manufacturer: Barco NV

## 6. Device description

E-2320 PA S is a display for medical viewing. It consists of 2 components: E-2320 PA S is a 20.1″ grayscale display. NioWatch is user-friendly software that allows to optimize the display for DICOM-compliant viewing.

## 7. Intended use

"The E-2320 PA S 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 two components:

- One 2-megapixel flat panel display (E-2320 PA S) .
- . NioWatch software

The flat panel display has a resolution of 1600x1200 pixels. It can be used in landscape and portrait mode.

The NioWatch software allows to set the display test patterns, calibrate the display and view additional display and display controller information.

Compared to the predicate device, the E-2320 PA S display has a different LCD panel with a smaller 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 E-2320 PA S is substantially equivalent to the predicate device, E 2621.

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 E-2320 PA S contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract human figures, represented by curved lines, facing to the right. The figures are stacked vertically, with the top figure being the largest and the bottom figure being the smallest.

Public Health Service

SEP 3 0 2005

Food and Drug Administrati 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052529 Trade/Device Name: E-2320 PA S Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 9, 2005 Received: September 15, 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) vilaling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality of your (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

Enclosure

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### INDICATIONS FOR USE

0(k) Number (if known): _ڀيڪي 529

Device Name: E-2320 PA S

Indications for Use:

*The E-2320 PA S is intended to be used in displaying digital images for review t trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

Prescription Use __XX_

(Part 21 CFR 801 Subpart D) AND/OR

(21 CFR 801 Subpart C)

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)

Daniel R. Leggson

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