(28 days)
Not Found
No
The summary only describes a digital image display system for viewing images and does not mention any AI/ML capabilities or performance metrics typically associated with such technologies.
No
The device is described as a display system for viewing and analyzing digital images, primarily serving as a tool for review rather than providing therapy itself.
No
The device is described as a display and viewing tool for digital images, intended for review and analysis by medical practitioners. It does not perform diagnostic functions itself, but rather presents images for the practitioner to diagnose.
Unknown
The summary describes a "digital image display system" consisting of "components to provide high resolution visualization of digital images." While it mentions "image processing," it doesn't explicitly state that the device is only software and doesn't include any dedicated hardware components beyond a standard display. The description of "components" is ambiguous and could include hardware.
Based on the provided information, the MGP 15 Dicom Theater device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "displaying and viewing digital images for review and analysis by trained medical practitioners." This describes a device used for visualizing existing medical images, not for performing tests on biological samples to diagnose or monitor a condition.
- Device Description: The description focuses on it being a "digital image display system" for "high resolution visualization of digital images." This aligns with image viewing, not in vitro testing.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Using reagents or assays
- Providing diagnostic results based on laboratory analysis
The device's function is to present medical images (likely from modalities like X-ray, CT, MRI, etc.) for interpretation by a medical professional. This falls under the category of medical image display systems, which are distinct from IVDs.
N/A
Intended Use / Indications for Use
The MGP 15 Dicom Theater device is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
The MGP 15 Dicom Theater is intended to be used as a tool in displaying and viewing digital images for review and analysis by trained medical practitioners.
Product codes
90LLZ
Device Description
The MGP 15 Dicom Theater device is a digital image display system
The MGP 15 Dicom Theater consists of components to provide high resolution visualization of digital images.
Mentions image processing
System, image processing
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
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
NOV 2 2 2004
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: | Dicom compliant projection system, medical
projector and others |
| Proprietary Name: | MGP 15 Dicom Theater |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Dicom Theater (K033153) and others |
| Device Description: | The MGP 15 Dicom Theater device is a digital
image display system |
| Intended Use: | The MGP 15 Dicom Theater device is intended
to be used in displaying and viewing digital
images for review by trained medical
practitioners. |
| Technological Characteristics: | The MGP 15 Dicom Theater consists of
components to provide high resolution
visualization of digital images. |
1
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 2 2004
Barco NV Barcoview % Mr. Frank Ferguson Official Correspondent FERGUSON MEDICAL 12200 Academy Road NE #931 ALBUQUERQUE NM 87111
Re: K042942
Trade/Device Name: MGP 15 Dicom Theater Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: October 10, 2004 Received: October 25, 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 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 (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 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 this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 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
Page 1 of 1
510(k) Number (If known):
Device Name: MGP 15 Dicom Theater
Indications For Use:
The MGP 15 Dicom Theater 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)
Prescription Use_ XX (Per 21 CFR 801.109)
OR
Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________
Nancy C. brordon
(Division Sign-Off)()
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042942