(71 days)
The Coronis Fusion 4MP DL (MDCC-4130) is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
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This document is a 510(k) clearance letter for the Barco Coronis Fusion 4MP DL (MDCC-4130) display device. It is a regulatory approval, not a study report. Therefore, it does not contain the information requested about acceptance criteria and a study proving device performance in the context of an AI/algorithm-based medical device.
The requested information pertains to studies typically performed for AI/ML-driven medical devices to demonstrate their diagnostic performance. This document, however, is for a display device (a monitor) and its clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, primarily focusing on its ability to display digital images for review.
Therefore, I cannot extract the requested information as it is not present in the provided text.
To provide an answer to your request, I would need a different type of document, such as a clinical study report or a 510(k) submission summary for an AI/algorithm device that analyzes medical images.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Lieven De Wandel Officer Regulatory & Environmental Affairs Barco n.v. President Kennedypark 35 8500 Kortrijk BELGIUM
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Re: K111989
Trade/Device Name: 4MP DL (MDCC-4130) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: H Product Code: LLZ Dated: September 9. 2011 Received: September 12, 2011
Dear Mr. De Wandel:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (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 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Pari 820). This letter will allow you to begin marketing your device as described in vour 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 Viro 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/cdrl/industry/support/index.html.
Sincerely Yours,
Mary Patel
Mary S. Pastel, Sc.D. · Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Coronis Fusion 4MP DL (MDCC-4130)
Indications For Use:
.
The Coronis Fusion 4MP DL (MDCC-4130) is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
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, Office of Device Evaluation (ODE)
Mary Pastel
Division Sigr Division of Radiological Device Division of Statuation and Safety >f In
K111989
.10K
Special 510(k) Submission Coronis Fusion 4MP DL - MDCC-4130
§ 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).