(207 days)
Not Found
No
The summary describes a medical display monitor and does not mention any AI or ML capabilities.
No
The device is described as a diagnostic display for viewing and analyzing medical images, not for treating conditions.
No
Explanation: The device is a display monitor used to view and display digital images for review and analysis by medical practitioners. While it aids in the diagnostic process by displaying images, it does not perform diagnostic functions itself. The "Device Description" states it is a "diagnostic display," but this term refers to its purpose in a diagnostic setting, not its functionality as a diagnostic tool that analyzes or processes data to generate a diagnosis.
No
The device description explicitly states it is a "high resolution monitor" and a "diagnostic display," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The MFGD 1318 is a display device. Its function is to display and view digital images. It does not perform any tests on biological samples.
- Intended Use: The intended use is for displaying and viewing digital images for review and analysis by medical practitioners. This is a display function, not a diagnostic test performed on a sample.
- Device Description: It is described as a "diagnostic display" and a "high resolution monitor." While it's used in a diagnostic context, the device itself is a display, not a diagnostic test.
Therefore, the MFGD 1318 falls under the category of a medical device used in the diagnostic process, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MFGD 1318 18 Inch 1 Megapixel Grayscale LCD Display 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
90LLZ
Device Description
The MFGD 1318 is a diagnostic display. The MFGD 1318 device is a high resolution monitor with electronic capabilities for evaluation of high resolution medical images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital images
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APR 1 9 2004
. . . . .
510(K) SUMMARY
| 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: | Medical flat panel grayscale display, monitor,
display and others |
| Proprietary Name: | MFGD 1318 |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Coronis 1MP Medical Flat Panel Display System
(K023340) |
| Device Description: | The MFGD 1318 is a diagnostic display |
| Intended Use: | The MFGD 1318 device is intended to be used
in displaying and viewing digital images for
review by trained medical practitioners. |
| Technological Characteristics: | The MFGD 1318 device is a high resolution
monitor with electronic capabilities for
evaluation of high resolution medical images. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle, with the eagle figure in the center.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2004
Barco NV Barcoview c/o Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road NE, #931 ALBUQUERQUE NM 87111
Re: K033005
Trade/Device Namc: MFGD 1318 18 Inch 1 Megapixel Grayscale LCD Display Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: July 14, 2003 Received: January 26, 2004
Dear Mr. Ferguson:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviews your been wined 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 encreament date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, do froos mat have 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 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 cither class II (Special Controls) or class III (PMA), it may be subject to 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 r rouse of a nove 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 sct forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (scctions 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) i his lefter will anow you to ocgainmanteang your antial equivalence of your device to a legally premarket notincation. The PDA momg or easing 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 If you desire specific advice for your dones to to.
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the president on the regulation entitled, "Misbranding Office of Compliance at (301) 57 - 1057.97) you may obtain. Other general by relerence to premarked notimoditors (r the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octorss http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincercly 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): K033005
Device Name: MFGD 1318
Indications For Use:
The MFGD 1318 18 Inch 1 Megapixel Grayscale LCD Display 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)
Emil G. Syverson
(Divison Sign-Off) Distrion of Reproductive, Abdorninal, anu Radiologica. Devices KO33005 510(k) Number ________
Prescription Use __ XX (Per 21 CFR 801.109)
Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________
OR