(257 days)
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.
Not Found
This FDA 510(k) clearance letter dated June 23, 2010, for the Coronis Fusion 10MP (MDCG-10130) display device does not contain the detailed information needed to answer the specific questions about acceptance criteria and the study proving device performance as requested.
The letter primarily:
- Confirms review of the 510(k) premarket notification.
- States the device is substantially equivalent to legally marketed predicate devices.
- Classifies the device as Class II (Picture archiving and communications system, Product Code LLZ).
- Outlines general regulatory requirements the manufacturer must adhere to.
- Includes an "Indications For Use" statement which specifies the device "is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners."
Crucially, this document does not elaborate on:
- Acceptance criteria (e.g., luminance, uniformity, calibration accuracy, spatial resolution, bit depth conformance for image display) that Barco NV had to meet for their device.
- Reported device performance against any specific criteria.
- Details of any studies conducted (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) to demonstrate the device meets those criteria.
Such details would typically be found in the original 510(k) submission document itself, which is a much more extensive technical dossier provided by the manufacturer to the FDA for review, rather than in the FDA's clearance letter. The clearance letter only announces the outcome of that review.
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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
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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 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
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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
§ 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).