(58 days)
Not Found
No
The summary describes a medical display system and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
This device is a medical diagnostic display system used by medical practitioners for viewing and analyzing digital images; it does not directly treat or alleviate a medical condition.
No
The device is a display system for viewing digital images, not a tool that performs a diagnosis itself. Its function is to facilitate the review and analysis of images by trained medical practitioners, who then make the diagnosis.
No
The device description explicitly states it "consists of components to provide high resolution visualization of digital images," implying hardware components are included. The intended use also describes a "Display System," which inherently involves hardware.
Based on the provided information, the Barco MeDis 5MP 5 MegaPixel Medical Diagnostic Display System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: IVDs are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. They perform tests in vitro (outside the body).
- Device Function: The Barco MeDis 5MP is a display system. Its function is to display and view digital images. It does not perform any tests on biological specimens.
- 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 specimen.
- Lack of IVD Characteristics: The description does not mention any components or processes related to handling or analyzing biological samples.
Therefore, the Barco MeDis 5MP falls under the category of a medical image display device, not an IVD.
N/A
Intended Use / Indications for Use
The Barco MeDis 5MP 5 MegaPixel Medical Diagnostic Display System is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.
Product codes
LLZ
Device Description
The MeDis 5MP device is a digital image display system.
Mentions image processing
Not Found
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
OCT 8 1038
510(k) SUMMARY
Barco NV/Display Systems A. Manufacturer : Theodoor Sevenslaan 106 8500 Kortrijk Belgium
Ferguson Medical Submitted By: Consultant to Barco NV
+32(0)56 23 32 11 Contact Information: Phone: B. +32(0)56 23 3 74 FAX:
- System, digital image ر Classification Name: communication
Image display system, medical image Common/usual Name: workstation, image monitor/display, and others
Barco MeDis 5MP 5 MegaPixel Medical Proprietary Name: Diagnostic Display System
- D. Classification Number: 90LMD
- Barco NV/Display E. Substantial Equivalence: Systems, MWD 321 Medical Workstation Display Barco Barco NV/Display Systems, Barco MGD 521 (K972701), 5 MegaPixel Diagnostic Display, and others.
- The MeDis 5MP device is a digital F. Device Description: image display system.
- 5MP 5 MegaPixel Medical G. Intended Use: The Barco MeDis Diagnostic Display System device is intended to be displaying and viewing digital images for in used review by trained medical practitioners.
- H . Technological Characteristics: The Barco MeDis 5MP 5 MegaPixel Medical Diagnostic Display System device of components to provide high resolution consists visualization of digital images.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 8 1998
Barco NV Display Systems c/o Frank Ferguson Ferguson Medical 2581 California Park Drive, Suite 269 Chico. CA 95928
Re:
K982820 Barco MeDis 5MP 5 MegaPixel Medical Diagnostic Display System Dated: May 20, 1998 Received: August 11, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Ferguson:
We have reviewed your Section 510(k) and intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for usestated in the enclosure) to 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 Federal Pood Drug, and Cosmetic Actor Your may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, abblings 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 maior regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medicals Devices: «Generalregulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition; FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in yitn diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odri/dsmaldsmamain.html".
Sincerely yours,
William Yu
Lillian Yin, Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
)510(k) Number (If known): 【(982820
Barco MeDis 5MP 5 MegaPixel Medical Diagnostic Device Name: Display System
Indications For Use:
The Barco MeDis 5MP 5 MegaPixel Medical Diagnostic Display System is intended to be used in displaying and viewing digital images 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. Segerson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological L 510(k) Number
Prescription Use ้ (Per 21 CFR 801.109)
Over-The-Counter Use _
(Optional Format 1-2-96)
OR