(184 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on image quality management, which is typically a rule-based or algorithmic process, not necessarily AI/ML.
No.
The device is described as a tool for medical practitioners to manage image softcopy quality, not to diagnose, treat, or prevent a disease or condition. It is an image quality management system rather than a direct therapeutic intervention.
No
The device is described as a tool for managing image softcopy quality, not for diagnosing medical conditions.
Unknown
The summary describes a digital image quality management system and mentions "image processing," which could be software-based. However, it doesn't explicitly state that the device is only software and provides no details about hardware components or their absence. The predicate device is described as "Display Conformity and Consistency Software," which leans towards software, but the summary for the subject device is not definitive.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "manage total image softcopy quality from a central location" for trained medical practitioners. This focuses on the quality of medical images themselves, not on analyzing biological samples or providing diagnostic information based on those samples.
- Device Description: It's described as a "digital image quality management system." This reinforces its role in managing image quality, not performing in vitro tests.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information derived from such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device's function is clearly related to managing the quality of medical images, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The Barco MediCal Administrator device is intended to be used as a tool for trained medical practitioners to manage total image softcopy quality from a central location.
Product codes
90 LLZ
Device Description
The MediCal Administrator device is a digital image quality management system
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(K) SUMMARY
K020073
ه
| Manufacturer: | Barco NV Display Systems
Theodoor Sevenslaan 106
8500 Kortrijk
Belgium |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Ferguson Medical
Consultant to Barco NV |
| Contact Information: | Phone: +32(0) 56 23 32 11
FAX: +32(0) 56 23 3 74 |
| Classification Name: | System, image processing |
| Common/Usual Name: | Image quality management system, hospital-
wide image quality management system,
client-server QA management system, and
others |
| Proprietary Name: | MediCal Administrator |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Barco NV Display Systems MediCal Display
Conformity and Consistency Software
(K982690) |
| Device Description: | The MediCal Administrator device is a digital
image quality management system |
| Intended Use: | The Barco MediCal Administrator device is
intended to be used as a tool for trained
medical practitioners to manage total image
softcopy quality from a central location |
| Technological Characteristics: | The MediCal Administrator device is a hospital-
wide system that tracks the consistency of
individual displays and keeps the data in a
central database |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2 2002
Barco NV Display Systems % Mr. Frank Ferguson Official Correspondent Ferguson Medical P.O. Box 12038 LA JOLLA CA 92039-2038 Re: K020073
Trade/Device Name: MediCal Administrator Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: April 20, 2002 Received: April 25, 2002
Dear Mr. Ferguson:
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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion 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 Part 807.97). Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy. C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
.
.
510(k) Number (If known):
Device Name: MediCal Administrator
Indications For Use:
The MediCal Administrator device is intended to be used as a tool for trained medical practitioners to manage total image softcopy quality from a central location.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seymour
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Prescription Use __ XX (Per 21 CFR 801.109)
OR
Over-The- Counter Use __________