(200 days)
Not Found
No
The summary describes a medical display monitor and does not mention any AI or ML capabilities.
No
The device is a display monitor for viewing medical images, which is a diagnostic tool, not a therapeutic one.
Yes
The "Device Description" explicitly states that "The MGD 2621L is a diagnostic display." Also, the "Intended Use" mentions it's for "review and analysis by trained medical practitioners," and the "Predicate Device" is also a "Diagnostic Display."
No
The device description explicitly states it is a "high resolution monitor" and a "diagnostic display," which are hardware components.
Based on the provided information, the MGD 2621L device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "displaying and viewing digital images for review by trained medical practitioners." This is a function related to image presentation and analysis, not the examination of specimens derived from the human body (which is the core of IVD).
- Device Description: It's described as a "diagnostic display" and a "high resolution monitor." These are hardware components for visual output, not devices that perform tests on biological samples.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances in biological samples.
- Providing information about a patient's health status based on laboratory tests.
The device's function is to present medical images (like X-rays, CT scans, etc.) for interpretation by a medical professional. This falls under the category of medical imaging display devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MGD 2621L device is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
The MGD 2621L Medical Grayscale Display is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
Product codes
90LLZ
Device Description
The MGD 2621L is a diagnostic display
The MGD 2621L device is a high resolution monitor with electronic capabilities for evaluation of high resolution medical images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital images
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
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
APR 1 6 2004
: 上一篇:
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510(K) SUMMARY
| Manufacturer: | Barco NV Barcoview
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: | Medical flat panel grayscale display, monitor,
display and others |
| Proprietary Name: | MGD 2621L |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Barco MGD 221 2 Megapixel Diagnostic Display
(K000293) |
| Device Description: | The MGD 2621L is a diagnostic display |
| Intended Use: | The MGD 2621L device is intended to be used
in displaying and viewing digital images for
review by trained medical practitioners. |
| Technological Characteristics: | The MGD 2621L device is a high resolution
monitor with electronic capabilities for
evaluation of high resolution medical images. |
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 2004
BARCO NV BARCOVIEW % Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road NE, # 931 ALBUQUERQUE NM 87111
Re: K033103 Trade/Device Name: MGD 2621L Medical Grayscale Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: July 14, 2003 Received: January 26, 2004
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 anproval 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 adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. Other general information on your 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
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510(k) Number (If known): K033103
Device Name: MGD 2621L
Indications For Use:
The MGD 2621L Medical Grayscale Display is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
please do not writte below this line - continue on another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ XX (Per 21 CFR 801.109)
OR
Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________
David A. Slyman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 5 ! O(k) Number ______________________________________________________________________________________________________________________________________________________________