BARCO 5MP MAMMO, MODEL MDMG-5221

K090603 · Barco N.V. · LLZ · Apr 22, 2009 · Radiology

Device Facts

• Record ID: K090603
• Device Name: BARCO 5MP MAMMO, MODEL MDMG-5221
• Applicant: Barco N.V.
• Product Code: LLZ · Radiology
• Decision Date: Apr 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The Barco 5MP Mammo device is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review and analysis by trained medical practitioners.

Device Story

Barco 5MP Mammo is a medical display system designed for viewing digital mammography images. It functions as a high-resolution monitor for radiologists and trained medical practitioners in clinical settings. The device receives digital image data from a Picture Archiving and Communication System (PACS) or similar imaging modality. It transforms these digital inputs into high-fidelity visual outputs, allowing clinicians to perform diagnostic review and analysis of mammographic images. The device supports standard and multi-frame digital mammography. By providing high-resolution visualization, it assists healthcare providers in interpreting diagnostic images, thereby supporting clinical decision-making and patient care.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

High-resolution medical display monitor for digital mammography. Operates as a component of a Picture Archiving and Communications System (PACS).

Indications for Use

Indicated for trained medical practitioners to display and view digital images, including standard and multi-frame digital mammography, for clinical 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).

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

APR 9 2 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Albert Xthona Product Manager Digital Mammography Barco NV Medical Imaging Division 15425 SW Beaverton Creek Court BEAVERTON OR 97006-5168

Re: K090603 .

Trade/Device Name: Barco 5MP Mammo Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 19, 2009 Received: March 5, 2009

Dear Mr. Xthona:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Laurence M. Marsh

Janine M. Morris Acting 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

K090603

510(k) Number (if known): Unknown

Device Name: Barco 5MP Mammo

## Indications For Use:

. .

. .

IThe Barco 5MP Mammo device is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review and analysis by trained medical practitioners.

Prescription Use × (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, Office of Device Evaluation (ODE) .

Arzum Khan

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

## 510(k) Submission Page D1

Barco 5MP Mammo Traditional 510(k) Appendix D1