NIO 5MP

K121788 · Barco N.V. · LLZ · Jul 23, 2012 · Radiology

Device Facts

• Record ID: K121788
• Device Name: NIO 5MP
• Applicant: Barco N.V.
• Product Code: LLZ · Radiology
• Decision Date: Jul 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The Nio 5MP (MDNG-6121) display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.

Device Story

Nio 5MP (MDNG-6121) is a high-resolution medical display system. It receives digital image data from a Picture Archiving and Communication System (PACS) or similar medical imaging source. The device transforms these digital signals into high-fidelity visual representations on a 5MP screen, optimized for diagnostic review of medical images, including digital mammography. Used in clinical environments (radiology departments, clinics) by trained medical practitioners (radiologists, clinicians). The display allows for precise visualization of anatomical structures and pathologies, facilitating accurate clinical decision-making and diagnosis. It serves as the primary interface for viewing diagnostic-quality images.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

5MP resolution medical-grade display. Designed for digital mammography and general radiology. Operates as a peripheral display unit for PACS. Complies with 21 CFR 892.2050 (Picture archiving and communications system).

Indications for Use

Indicated for trained medical practitioners to display and view digital images, including 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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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 lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.

## 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 NV Healthcare Division 35 President Kennedy Park KORTRIJK 8500 BELGIUM

JUL 2 3 2012

Re: K121788

Trade/Device Name: Nio 5MP (MDNG-6121) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 4, 2012 Received: June 18, 2012

Dear Mr. De Wandel:

We have reviewed your Section 510(k) premarket notification of intent to market the device w onave a sowe 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 for use stated in the enerobate) to 16gms actment date of the Medical Device Amendments, or to conniner of the ro 114) 20, 2011 11:11 in accordance with the provisions of the Federal Food, Drug, de vices that mave been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dicrerer, mains 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 11 your device is exassified (ooo 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Drimal statutes and regulations administered by other Federal agencies. You must or ury 1 outer statutes and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 GBR-Patiss®01 and 809);amedical 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,

Janine M. Morris

Acting 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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## Indications for Use

510(k) Number (if known): K121788

Device Name: Nio 5MP (MDNG-6121)

Indications for Use: The Nio 5MP (MDNG-6121) display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number_K121788

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