(15 days)
Not Found
No
The document describes a medical display monitor and its associated control board, which are used for displaying digital medical images. There is no mention of AI, ML, or any algorithms that would process or analyze the images beyond simple display functions. The device is a passive display system.
No
The device is a monitor system for displaying medical images, not for treating conditions or diseases.
No
The device is a monitor system used for displaying medical images; it does not perform any diagnostic analysis itself.
No
The device description explicitly states the system consists of a "state-of-the-art LCD monitor and a high-resolution graphic control board," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "display and view digital medical images for review and analysis by trained medical practitioners." This describes a device used for visualizing medical images, not for testing samples taken from the human body (like blood, urine, tissue, etc.) to diagnose or monitor a condition.
- Device Description: The description focuses on the hardware (LCD monitor, graphic control board) used for displaying images from a PACS workstation. It doesn't mention any components or processes related to analyzing biological samples.
- Mentions image processing: While it mentions "IMAGE PROCESSING," this is in the context of displaying radiological images, which is different from the processing of biological samples for diagnostic purposes.
- Input Imaging Modality: The input is "digital medical images," not biological samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is solely to display pre-existing medical images.
N/A
Intended Use / Indications for Use
The 2MP TFT LCD Monitor System IF1902A ™ is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners.
Product codes
LLZ, 90 LLZ
Device Description
The WIDE 2MP TFT LCD Monitor System IF1902A ™ is a flat panel hi-resolution LCD monitor system for displaying digital medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale image display. The WIDE controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.
Mentions image processing
Yes
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)
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 2003
Image /page/0/Picture/1 description: The image shows the word "WIDE" in large, bold, white letters against a black background. Below the word "WIDE" is smaller text that reads "World Innovative Display Engineering". The text is also in white. The image has a slightly grainy or textured appearance.
K$\phi$329 b$\phi$
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared: August 4, 2003
Submitter's Information: 21 CFR 807.92(a)(1) WIDE Corporation Mr. YS Lim, President & CEO 576-5 Miwon-Ri, Miwon-Myun, Cheongwon-Gun Chung, Korea 363-874
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) WIDE 2MP TFT LCD Monitor System IF1902A ™ Trade Name: Picture Archiving Communications System Common Name: Device Classification: 892.2050 System, Image Processing Name:
Predicate Device: 21 CFR 807. 92(a)(3)
| Device Classification Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
|---|---|
| Regulation Number | 892.2050 |
| 510(k) Number | K023322 |
| Device Name | CORNIS 2MP MEDICAL FLAT PANEL DISPLAY |
| SYSTEM | |
| Applicant | BARCO NV |
| P.O. BOX 12038 | |
| LA JOLLA, CA 92039 2038 | |
| Product Code | LLZ |
Device Description: 21 CFR 807 92(a)(4)
The WIDE 2MP TFT LCD Monitor System IF1902A ™ is a flat panel hi-resolution LCD monitor system for displaying digital medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale image display. The WIDE controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.
Indications for Use: 21 CFR 807 92(a)(5)
The WIDE 2MP TFT LCD Monitor System IF1902A ™s intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners.
1
Image /page/1/Picture/0 description: The image shows the word "WIDE" in large, bold, white letters against a black background. Below the word "WIDE" is smaller text that reads "World Innovative Leading Engineering". The text is also white against the black background. The image appears to be a logo or branding element.
K$\phi$3296$\phi$
Technological Characteristics: 21 CFR 807 92(a)(6)
The device is an image display system consisting of computer software and components. The device does not contact the patient, nor does it control any life sustaining devices. A physician or trained medical practitioner provides ample opportunity for competent human intervention to interpret images and information being displayed.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for the WIDE 2MP TFT LCD Monitor System IF1902A ™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
The WIDE 2MP TFT LCD Monitor System IF1902A ™will be manufactured by WIDE Corporation in accordance with the voluntary and safety standards, i.e. Safety / Immunity UL2601-1/EN60601-1 / IEC601-1, FCC Class B, CE, VCC, UL 950, cUL2601-1, CE Mark EMC/IEC = VCCI, CE, MIC FCC Class B digital device, pursuant to Part 15.
The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor.
2
Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 8 2003
WIDE Corporation % Mr. Ned Devine Responsible Third Party Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548 Re: K032960
Trade/Device Name: WIDE 2MP TFT LCD Monitor Systems IF 1902A™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: August 25, 2003
Received: September 23, 2003
Dear Mr. Devine:
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.
3
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 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/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
4
Page 1 of -1
(Indications for Use Form)
510(k) Number:
K∅3296∅
Device Name: WIDE 2MP TFT LCD Monitor System IF1902A ™
Indications for Use:
The 2MP TFT LCD Monitor System IF1902A ™ is intended to be used in displaying and viewing digital medical 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)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Narieyt Brogdon
(Division Sign Off)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K032960