(85 days)
Not Found
No
The summary describes a digital image display system for viewing images, with no mention of AI, ML, or related concepts like algorithms for analysis or interpretation beyond simple display.
No
The device is described as a display system for viewing and analyzing digital images, which facilitates diagnosis rather than directly preventing, treating, or mitigating a disease or condition.
Yes
The "Intended Use / Indications for Use" states the device is "intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners," and it lists a "Medical Diagnostic Display System" as a predicate device, which indicates its use in diagnostics.
Unknown
The summary describes a "digital image display system" consisting of "components to provide high resolution visualization." While it mentions "image processing," it doesn't explicitly state that the device is solely software and doesn't include dedicated hardware components beyond a standard display. The predicate device is a "Medical Diagnostic Display System," which is typically a hardware device. Without a clear statement that the device is software-only, it's impossible to definitively classify it as such based on this summary.
Based on the provided information, the ImageDesk device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- ImageDesk Function: The ImageDesk device is described as a "digital image display system" intended for "displaying and viewing digital images for review and analysis." It processes and displays images, but it does not perform tests on biological samples.
- Lack of Biological Sample Interaction: There is no mention of the device interacting with or analyzing biological samples. Its function is solely related to the visualization of pre-existing digital images.
Therefore, the ImageDesk device falls under the category of medical imaging display systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ImageDesk device is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.
Product codes
90 LLZ
Device Description
The ImageDesk device is a digital image display system
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
APR 0 3 2002
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1
510(K) SUMMARY
:
| 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: | ImageDesk 2W 2MP, ImageDesk 4W 2MP,
ImageDesk 2W 5MP, ImageDesk 4W 5MP,
Radiology Display System, and others |
| Proprietary Name: | ImageDesk |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Barco NV Display Systems MeDis 5MP2 Dual-
Head Medical Diagnostic Display System
(K001753) |
| Device Description: | The ImageDesk device is a digital image
display system |
| Intended Use: | The Barco ImageDesk device is intended to be
used in displaying and viewing digital images
for review and analysis by trained medical
practitioners |
| Technological Characteristics: | The ImageDesk device is a system consisting
of components to provide high resolution
visualization of digital images |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 3 2002
Barco NV Display Systems % Mr. Frank Ferguson Official Correspondent Ferguson Medical P.O. Box 12038 LA JOLLA CA 92039-2038 Re: K020061
Trade/Device Name: ImageDesk Radiology Display System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 20, 2001 Received: January 8, 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 mav 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 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
3
510(k) Number (If known):
Device Name: ImageDesk
Indications For Use:
The ImageDesk device is intended to be used 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)
David A. Simpson
Prescription Use __ XX -(Per 21 CFR 801.109)
OR
Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________