(257 days)
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Not Found
No
The summary does not mention AI, ML, or any related terms, nor does it describe features or studies typically associated with AI/ML-powered devices.
No
The device is strictly for displaying and viewing digital images for review and analysis, not for treatment or therapy.
No
The device is described as a display and viewing tool for digital images, including mammography, intended for review and analysis by medical practitioners. It does not perform diagnostic functions itself, but rather presents images for human interpretation.
No
The description explicitly states the device is for "displaying and viewing digital images," which strongly implies a hardware component (a display monitor) is the primary device, with software likely running on or controlling it. The lack of a "Device Description" section prevents confirmation, but the intended use points away from a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "displaying and viewing digital images... for review and analysis by trained medical practitioners." This describes a device used to present medical images, not a device that performs tests on biological samples to diagnose conditions.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information about a patient's health status based on laboratory tests
The device described is a medical display monitor used for viewing medical images, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Coronis Fusion 10MP (MDCG-10130) is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
Product codes
LLZ
Device Description
Coronis Fusion 10MP (MDCG-10130)
Mentions image processing
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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
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Description of the test set, sample size, data source, and annotation protocol
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake winding around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Roon1 - WO66-G609 Silver Spring, MD 20993-0002
Mr. Lieven De Wandel Officer Regulatory & Environmental Affairs Barco NV, Medical Imaging Division 35 President Kennedypark Kortrijk, B-8500 BELGIUM
JUN 2 3 2010
Re: K093197
Trade/Device Name: Coronis Fusion 10MP (MDCG-10130) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 11, 2010 Received: June 14, 2010
Dear Mr. De Wandel:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because 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). and Cosmetic real (110.) him to nevice, subject to the general controls provisions of the Act. The r ou may, aron's 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 class II (Special Controls), it may be subject to such 11 your device to trols. Existing major regulations affecting your device can be found in Title 21, additional occasions (CFR), Parts 800 to 895. 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 1 touse of actived that Frentination that your device complies with other requirements of the Act that I Dr Has Intact a and regulations administered by other Federal agencies. You must or any 1 could statutes and regarments, including, but not limited to: registration and listing (21 comply with an the rece orequently and 809); medical device reporting (reporting of
1
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Donald J. Trump
Donald J. St.Pierre Acting Director . Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications For Use
510(k) Number (if known):
Device Name: Coronis Fusion 10MP (MDCG-10130)
Indications For Use:
. - - - - - - - -
. .
The Coronis Fusion 10MP (MDCG-10130) is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
Prescription Use × (Part 21 CFR 801 Subpart D) OR
Over-The-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH; @ffice of Device Evaluation (QBE)
Robert J. Becker
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K093197