(64 days)
The Barco MediCal Display Conformity and Consistency Software device is intended to be used as a tool in displaying and viewing digital images for review and analysis by trained medical practitioners.
The MediCal device is image consistency and calibration software package.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, test study details (sample size, data provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone algorithm performance, ground truth types, or training set specifics. The document is a 510(k) summary for a medical device called "Barco MediCal Display Conformity and Consistency Software," which is image consistency and calibration software. It describes the manufacturer, contact information, classification, intended use, and technological characteristics, as well as the FDA's clearance letter. However, it lacks the detailed performance study information you've requested.
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510(k) SUMMARY
A. Manufacturer: Barco NV/Display Systems Theodoor Sevenslaan 106 8500 Kortrijk Belgium
Submitted By:
Ferguson Medical Consultant to Barco NV
B. Contact Information: Phone: +32(0)56 23 32 11 FAX: +32(0)56 23 3 74
- C. Classification Name: System, digital image communication
Common/usual Name: Consistency software, image conformity software, and others.
Proprietary Name: Barco MediCal Display Conformity and Consistency Software
- D. Classification Number: 90LMD
- E. Substantial Equivalence: Barco NV/Display Systems, Barco MWD 321 Medical Workstation Display (K972701), and Barco NV/Display Systems, Barco MGD 521 5 MegaPixel Diagnostic Display.
- F. Device Description: The MediCal device is image consistency and calibration software package.
- ে. Intended Use: The Barco MediCal Display Conformity and Consistency Software device is intended to be used a tool in displaying and viewing digital images વડ for review by trained medical practitioners.
- Characteristics: H . Technological The Barco MediCal Display Conformity and Consistency Software device is a software tool for use in providing consistency in softcopy images.
OCT 6 1998
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 6 1998
Barco NV Display Systems c/o Frank Ferguson Official Correspondent Ferguson Medical 3407 Bay Avenue Chico, CA 95973
Re:
K982690 Barco Medical Display Conformity and Consistency Software Dated: May 15, 1998 Received: August 3, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Ferguson:
We have reviewed your Section 510(s) notification of intention market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Drue, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/edrh/dsmain.html".
Sincerely yours,
Kilian Yi
Lillian Yin. Ph.D Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and . Radiological Health
Enclosure
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510(k) Number (If known): K982690
Barco MediCal Display Conformity and Consistency bevice Name: Software
Indications For Use:
The Barco MediCal Display Conformity and Consistency Software device is intended to be used as a tool in displaying and viewing digital 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)
Daniel C. Syverson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Device 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use _
(Optional Format 1-2-96)
OR
§ 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).