(135 days)
Not Found
No
The document describes a medical display system and does not mention AI, ML, or any related technologies in its description, intended use, or performance studies. The focus is on image display and processing, which are standard functions of such devices.
No.
This device is a display system for medical images, intended for review and analysis by medical practitioners, and does not directly provide therapy.
No
The device is a display system for medical images, not a tool that performs a diagnosis itself. It is intended for review and analysis by trained medical practitioners, who would then make the diagnosis.
No
The device description explicitly states it "consists of components to provide high resolution visualization of digital images," indicating it includes hardware (a flat panel display system).
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.
- Device Function: The Coronis 5MP Medical Flat Panel Display System is a display system used for viewing digital images. It does not perform any tests on biological samples.
- Intended Use: The intended use is to display and view digital images for review and analysis by medical practitioners. This is a display function, not a diagnostic test performed on a sample.
Therefore, the Coronis 5MP Medical Flat Panel Display System falls under the category of a medical image display device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Coronis 5MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images, including digital mammography, for review by trained medical practitioners.
The Coronis 5MP Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
Product codes (comma separated list FDA assigned to the subject device)
90LLZ, LLZ
Device Description
The Coronis 5MP device is a digital image display system.
The Coronis 5MP device consists of components to provide high resolution visualization of digital images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
digital images, including digital mammography
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).
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DEC 3 0 2004
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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: | Image display system, medical image
workstation, image monitor/display, and others |
| Proprietary Name: | Coronis 5MP Medical Flat Panel Display System |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Coronis 5MP Medical Flat Panel Display System
(K013922), Dome CX Digital Flat Panel Display
System, Model C5i (K040443) and others |
| Device Description: | The Coronis 5MP device is a digital image
display system |
| Intended Use: | The Coronis 5MP Medical Flat Panel Display
System is intended to be used in displaying
and viewing digital images, including digital
mammography, for review by trained medical
practitioners. |
| Technological Characteristics: | The Coronis 5MP device consists of
components to provide high resolution
visualization of digital 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 caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2004
Barco NV Barcoview c/o Mr. Frank Ferguson Ferguson Medical 12200 Academy Road NE #931 ALBUQUERQUE NM 87111
K042221 Device Name: Coronis 5MP Medical Flat Panel Display System Regulation Number: 21 CFR 892.2050 Regulatory Class: Class II Product Code: LLZ Dated: December 14, 2004 Received: December 16, 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 (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) 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/cdrb/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
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510(k) Number (If known): K042221
Device Name: Coronis 5MP Medical Flat Panel Display System
Indications For Use:
The Coronis 5MP Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images, including 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)
Nancy C. Brogdon
Prescription Use _ ్ల (Per 21 CFR 801.109)
OR
Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________