(206 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on image display and visualization, not algorithmic analysis.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is described as a tool for displaying and viewing digital images for review and analysis, indicating a diagnostic or assistive function rather than a direct therapeutic one.
Yes
The device is described as a tool for displaying and viewing digital images for review and analysis by trained medical practitioners, which is a diagnostic activity.
No
The device description explicitly states it "consists of components to provide high resolution visualization of digital images," and the predicate device is a "Medical Flat Panel Display System," which is a hardware component. This indicates the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to display and view digital images for review and analysis by medical practitioners. This is a function related to medical imaging, not the analysis of biological samples (like blood, urine, tissue, etc.) which is the core of IVD devices.
- Device Description: The description focuses on displaying digital images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This device's function is purely related to the visualization of medical images.
N/A
Intended Use / Indications for Use
The DICOM Theater device is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
The DICOM Theater device 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 (comma separated list FDA assigned to the subject device)
90LLZ
Device Description
The DICOM Theater device is a digital image display system
The 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
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
APR 2 3 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: | DICOM Theater |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Coronis 1MP Medical Flat Panel Display System
(K023340) |
| Device Description: | The DICOM Theater device is a digital image
display system |
| Intended Use: | The DICOM Theater device is intended to be
used in displaying and viewing digital images
for review by trained medical practitioners. |
| Technological Characteristics: | The DICOM Theater consists of components to
provide high resolution visualization of digital
images. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
APR 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Barco NV Barcoview c/o Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road NE, #931 ALBUQUERQUE NM 87111
Rc: K033153
Trade/Device Name: DICOM Theater Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: August 14, 2003 Received: January 26, 2004
Dear Mr. Ferguson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon - 10(t) prelievice is substantially equivalent (for the indications felerenced above and nave doloring and marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1770, the encordance with the provisions of the Federal Food, Drug, devices ular have occh reciasinou in assess approval of a premarket approval application (PMA). and Cosmelle Act (Act) that to not require approvisions of the general controls provisions of the Act. The 1 ou may, ulcic.org, market the act include requirements for annual registration, listing of general controls provisions of the fleet labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classifica (300 above) into exist regulations affecting your device can be it may be subject to additional controllars, 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 Please be auvised that FDA 3 issualled of a baseaan in other requirements of the Act that FDA has made a decisimilation administered by other Federal agencies. You must or ally Federal Statutes and regulations and limited to: registration and listing comply with an the Act STEquirements, invally, good manufacturing practice requirements as sch (21 CFR Part 807), labelling (21 OFF Part 820); and if applicable, the electronic forth in the quality 355tons (Q5) rog (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) This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The PDA inding of substantial ogardevice and this, 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 If you desire spectific advice for your device on our lassing organism of
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 devices, please contact the Additionally, for questions of the pronotion and and the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Asso, please and tain Other general Othce of Compliance at (501) 594-4057. 7230, post 807.97) you may obtain. Other general by reference to premarket nonitation (21 or read on the Act may be obtained from the Division of Small information on your responsionities uncer assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free demanain Manutacturers, International and Collsumor Pissioners and consumers of the manain.html.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/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
Page 2
3
510(k) Number (If known); K033153
Device Name: DICOM Theater
Indications For Use:
The DICOM Theater device 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 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 ________________________________________________________________________________________________________________________________________________________
Daniel A. Lynn
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 5 ( ( l ( l ( l ) Number _