BARCO MAMMO TOMOSYNTHESIS

K103792 · Barco N.V. · LLZ · Mar 4, 2011 · Radiology

Device Facts

• Record ID: K103792
• Device Name: BARCO MAMMO TOMOSYNTHESIS
• Applicant: Barco N.V.
• Product Code: LLZ · Radiology
• Decision Date: Mar 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The Barco Mammo Tomosynthesis (MDMG-5221) device is intended to be used in displaying digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

Device Story

Barco Mammo Tomosynthesis (MDMG-5221) is a medical display system designed for high-resolution visualization of digital mammography and breast tomosynthesis images. Device receives digital image data from PACS or imaging modalities; processes and renders images on a specialized high-resolution display monitor. Used in clinical environments (radiology departments, breast imaging centers) by radiologists and trained medical practitioners. Output allows clinicians to review, analyze, and interpret breast images for diagnostic purposes. Facilitates accurate assessment of breast tissue, aiding in detection and diagnosis of breast abnormalities. Device functions as a visualization tool within the diagnostic imaging workflow.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

High-resolution medical display monitor for digital mammography and tomosynthesis. Connectivity via standard digital imaging interfaces (e.g., DVI/DisplayPort). Designed for grayscale and/or color medical image rendering. Complies with DICOM Part 14 for grayscale display function. Software-based calibration and quality assurance tools included.

Indications for Use

Indicated for trained medical practitioners to display, review, analyze, and diagnose digital images, including standard and multi-frame digital mammography and breast tomosynthesis 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

• Barco Mammo Tomosynthesis (K103292)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Lieven De Wandel Regulatory Affairs Officer Barco N.V., Medical Imaging Division 35 President Kennedypark Kortrijk, 85000 BELGIUM

MAR - 4 2011

Re: K103792

Trade/Device Name: Braco Mammo Tomosynthesis (MDMG-5221) Regulation Number: 21 CFR 892.2050 . Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 22, 2010 Received: December 27, 2010

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Mary S Pastel

Mary Pastel. ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K103792

Unknown

## Device Name:

Barco Mammo Tomosynthesis (MDMG-5221)

## Indications For Use:

The Barco Mammo Tomosynthesis (MDMG-5221) device is intended to be used in displaying digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners.

It is specially designed for breast tomosynthesis applications.

Prescription Use X (Part 21 CFR 801 Subpart D) OR

Over-The-counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, @ffice of Device Evaluation (OBE) OLD T

Mary S. Pastel
(Division Dir. or)

sion Sign Division of Radiological Office of In Vitro Diagnostic Diagnostic D

510K. K103292

510(k) Submission Page D1

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