(270 days)
MFCD 118 (K000291)
Not Found
No
The summary describes a display monitor and mentions "image processing" but does not contain any terms or descriptions indicative of AI or ML technology.
No
The device is described as a diagnostic display for viewing and analyzing medical images, which are typically used for diagnosis rather than therapy. Its intended use as a "tool in displaying and viewing digital images" does not involve treating or alleviating a condition.
No
The 'Intended Use' section states it's "intended to be used as a tool in displaying and viewing digital images... for review and analysis," indicating it's a display device rather than a diagnostic device that performs analysis itself. While the 'Device Description' calls it a "diagnostic display," its function is solely to show images for practitioners to analyze.
No
The device description explicitly states it is a "high resolution monitor," which is a hardware component.
Based on the provided information, the MIVD 1218 18 Inch Grayscale Display Module is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to display and view digital images for review and analysis by medical practitioners. This is a function related to medical imaging, not the analysis of biological samples (which is the core of IVD).
- Device Description: It's described as a "diagnostic display" and a "high resolution monitor." These are terms associated with medical imaging displays, not IVD devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD testing.
In summary, the MIVD 1218 is a medical imaging display, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MIVD 1218 device is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
The MIVD 1218 18 Inch Grayscale Display Module 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 MIVD 1218 is a diagnostic display
The MIVD 1218 device is a high resolution monitor with electronic capabilities for evaluation of high resolution medical images.
Mentions image processing
System, image processing
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)
MFCD 118 (K000291)
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 2 0 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: | MIVD 1218 |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | MFCD 118 (K000291) |
| Device Description: | The MIVD 1218 is a diagnostic display |
| Intended Use: | The MIVD 1218 device is intended to be used
in displaying and viewing digital images for
review by trained medical practitioners. |
| Technological Characteristics: | The MIVD 1218 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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an eagle with its wings spread, with three lines above it. The eagle is facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 2004
Barco NV BarcoView c/o Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road NE, #931 ALBUQUERQUE NM 87111
Re: K033006
Trade/Device Name: MIVD 1218 18 Inch Grayscale Display Module Regulation Number: 21 CFR §892.2050 Regulation Namc: 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 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 (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 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 (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.
2
This letter will allow you to begin marketing your device as described in your Section 510(k)
. I a legally This letter will allow you to begin marketing your artial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivaleries and the premarket notification. The FDA inding of substantial of arrants of 5-5
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
r the could be and on and of the first of the sumbers, becad on the requira If you desire specific advice for your device on our his may be 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 promotion in the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. 1979, 2017 97 Other of Compliance at (501) 594-1057. FL00, percessor.97) you may obtain. Other geceeral by reference to prematical (21 of 1 x 1 x 1 x 1 x 1 x 8 x 4 x 4 x 4 x 4 x 4 x 4 x 4 x 1 x 1 x 1 x 1 x 1 x 1 information on your responsibilities under the Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-d (11 may Manufacturers, International and Consumer i Issionw.ida.gov/cdrh/dsma/dsmamain.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
Page 2
3
510(k) Number (If known): K033006
Device Name: MIVD 1218
Indications For Use:
The MIVD 1218 18 Inch Grayscale Display Module 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 R. Lymm
(Division Sign-Off)
Division of Reproductive, Abdominal, ane Padiological Devices 1550 5 11)(k) Number ______________________________________________________________________________________________________________________________________________________________
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR
Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________