(32 days)
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No
The summary describes a medical flat panel display system for viewing digital images and does not mention any AI or ML capabilities.
No
The device is a medical display system, which shows images for review but does not directly treat or diagnose conditions.
No
This device is a display system used for viewing digital images, not for making a diagnosis itself. The text explicitly states, "These devices must not be used in primary image diagnosis in mammography."
No
The device description explicitly states it is a "Medical Flat Panel Display System," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "displaying and viewing digital images for review by trained medical practitioners." This describes a device used for visualizing medical images, not for performing tests on biological samples (which is the core function of an IVD).
- Device Description: It's a "Medical Flat Panel Display System." This is a hardware component for displaying images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device's function is solely to display images, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The MDNC-3121 Medical Flat Panel Display System 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. The MDNC-3121, which is part of the Nio Color 3MP system, will be marketed separately.
Product codes
LLZ
Device Description
Nio Color 3MP (MDNC-3121)
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained medical practitioners
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 2009
Mr. Lieven De Wandel Regulatory Affairs Officer Barco N.V., Medical Imaging Division 35 president kennedypark Kortrijk, B-8500 BELGIUM
Re: K090732 .
Trade/Device Name: Nio Color 3MP (MDNC-3121) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 17, 2009 Received: March 26, 2009
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 o 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 (OS) 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) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
[signature]
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
KC90732
510(k) Number (if known): Unknown
Device Name:
Nio Color 3MP (MDNC-3121)
Indications For Use:
The MDNC-3121 Medical Flat Panel Display System 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. The MDNC-3121, which is part of the Nio Color 3MP system, will be marketed separately.
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)
Hula Lemen
(Division Sign-Off) Division of Reproductive. Abdomi Radiological De 510(k) Number
Nio Color 3MP (MDNC-3121) Special 510(k) - Page F1