(52 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on image display and processing, not AI/ML-driven analysis or interpretation.
No.
The device is a display system for medical images, not a device that directly treats a condition or disease.
No
The device is a display system, not a diagnostic device. It's intended for viewing and analyzing digital images, but it does not perform any diagnostic functions itself. It's a tool for medical practitioners, but the diagnosis is made by the practitioner, not the display.
No
The device description explicitly states it is a "digital image display system" and "consists of components to provide high resolution visualization of digital images," indicating it includes hardware components (the display panel and associated electronics) in addition to any potential software.
Based on the provided information, the Nio 2MP Medical Flat Panel Display System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: IVDs are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This is typically done in vitro (outside the body).
- Nio 2MP's intended use: The Nio 2MP is clearly described as a system for displaying and viewing digital images for review and analysis by medical practitioners. These images are generated by imaging modalities (like X-ray, CT, MRI, etc.), not from analyzing biological specimens.
- Device description: The description focuses on the display system and its components for visualizing images.
- Lack of mention of biological specimens or analysis: There is no mention of the device interacting with or analyzing biological samples.
Therefore, the Nio 2MP falls under the category of medical imaging display systems, not IVDs.
N/A
Intended Use / Indications for Use
The Nio 2MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images, excluding digital mammography, for review by trained medical practitioners.
The Nio 2MP Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
The Nio 2MP device is a digital image display system
Mentions image processing
System, image processing
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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
510(K) SUMMARY
NOV 19 2004
:
| Manufacturer: | Barco NV Barcoview
Theodoor Sevenslaan 106
8500 Kortrijk
Belgium |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Ferguson Medical
Consultant to Barco NV |
| Contact Information: | Phone: +32(0) 56 23 32 11
FAX: +32(0) 56 23 3 74 |
| Classification Name: | System, image processing |
| Common/Usual Name: | Image display system, medical image
workstation, image monitor/display, and others |
| Proprietary Name: | Nio 2MP Medical Flat Panel Display System |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Nio 2MP Medical Grayscale Display System
(K040039) |
| Device Description: | The Nio 2MP device is a digital image display
system |
| Intended Use: | The Nio 2MP Medical Flat Panel Display System
is intended to be used in displaying and
viewing digital images, excluding digital
mammography, for review by trained medical
practitioners. |
| Technological Characteristics: | The Nio 2MP device consists of components to
provide high resolution visualization of digital
images. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2004
Barco NV Barcoview % Mr. Frank Ferguson Official Correspondent FERGUSON MEDICAL 12200 Academy Road NE #931 ALBUQUERQUE NM 87111
Re: K042660 Trade/Device Name: Nio 2MP Medical Flat Panel Display System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: September 23, 2004 Received: October 4, 2004
Dear Mr. Ferguson:
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); labeling (21 CFR Part 801); 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.
2
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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number (If known):
Device Name: Nio 2MP Medical Flat Panel Display System
Indications For Use:
The Nio 2MP Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE. ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Swanson
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________