(67 days)
Not Found
None
No
The summary describes a display device for medical images, not a device that processes or analyzes images using AI/ML.
No.
The device is described as displaying digital images for review, analysis, and diagnosis, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as being used for "review, analysis, and diagnosis by trained medical practitioners," which explicitly states its role in the diagnostic process.
No
The summary describes a device intended for displaying digital images, specifically for mammography and breast tomosynthesis. While it processes digital images, the description focuses on the display function, which typically involves hardware (a monitor or display system). There is no explicit mention of the device being solely software, and the name "Barco Mammo Tomosynthesis (MDMG-5221)" suggests a hardware component (Barco is a known display manufacturer).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to obtain information about a person's health.
- This device is used to display and analyze medical images (digital mammography and tomosynthesis) that are generated from within the body.
The device's function is to present visual information derived from imaging modalities, not to perform tests on biological samples.
N/A
Intended Use / Indications for Use
The Barco Mammo Tomosynthesis (MDMG-5221) device is intended to be used in displaying digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners.
It is specially designed for breast tomosynthesis applications.
Product codes
LLZ
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
digital images, including standard and multi-frame digital mammography, breast tomosynthesis
Anatomical Site
breast
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 Regulatory Affairs Officer Barco N.V., Medical Imaging Division 35 President Kennedypark Kortrijk, 85000 BELGIUM
MAR - 4 2011
Re: K103792
Trade/Device Name: Braco Mammo Tomosynthesis (MDMG-5221) Regulation Number: 21 CFR 892.2050 . Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 22, 2010 Received: December 27, 2010
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
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.
Mary S Pastel
Mary Pastel. ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K103792
Unknown
Device Name:
Barco Mammo Tomosynthesis (MDMG-5221)
Indications For Use:
The Barco Mammo Tomosynthesis (MDMG-5221) device is intended to be used in displaying digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners.
It is specially designed for breast tomosynthesis applications.
Prescription Use X (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 (OBE) OLD T
Mary S. Pastel
(Division Dir. or)
sion Sign Division of Radiological Office of In Vitro Diagnostic Diagnostic D
510K. K103292
510(k) Submission Page D1
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