(15 days)
Not Found
No
The summary describes a medical display system (monitor and graphics card) and does not mention any AI or ML capabilities for image analysis or processing beyond standard display functions.
No
The device is a display system for medical images, not a device that directly treats or prevents a medical condition.
No.
Explanation: The device is a display system for viewing medical images, not for performing diagnosis itself. Its purpose is to present images for review and analysis by medical practitioners.
No
The device description explicitly states it consists of a "LCD monitor and a highresolution graphic control board," which are hardware components.
No, this 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.
- Device Function: The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™ is a display system for viewing medical images. It does not perform any tests on biological samples. Its function is to present images generated by other medical devices (like PACS workstations) for interpretation by medical practitioners.
The provided information clearly describes a display system for medical images, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C3 Color™ and C3 Gray™ are intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C3 Color™ and C3 Gray™ are flat panel hi-resolution LCD monitor systems for displaying medical images. The system consists of a LCD monitor and a highresolution graphic control board that connects to a PACS workstation for image display. The controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.
Mentions image processing
Not Found
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): 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
K03 263 8
SEP 1 1 2003
PLANAR
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
August 1, 2003
Submitter's Information: 21 CFR 807.92(a)(1)
Ms. Susan Hamann Planar Systems, Inc. 400 Fifth Ave. Waltham, MA 02451-8738 USA
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | DOME CXTM DIGITAL FLAT-PANEL DISPLAY
SYSTEMTM, Models C3 ColorTM and C3 GrayTM |
|-----------------|-----------------------------------------------------------------------------------|
| Common Name: | Picture Archiving Communications System |
| Classification: | 892.2050 |
| Name: | System, Image Processing |
Predicate Device: 21 CFR 807. 92(a)(3)
| Device Classification
| Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
|---|---|
| Regulation Number | 892.2050 |
| 510(k) Number | K013922 |
| Device Name | CORNIS 3MP MEDICAL FLAT PANEL DISPLAY |
| SYSTEM | |
| Applicant | BARCO NV |
| P.O. BOX 12038 | |
| LA JOLLA, CA 92039 2038 | |
| Product Code | LLZ |
| Decision Date | 01/28/2002 |
Device Description: 21 CFR 807 92(a)(4)
The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C3 Color™ and C3 Gray™ are flat panel hi-resolution LCD monitor systems for displaying medical images. The system consists of a LCD monitor and a highresolution graphic control board that connects to a PACS workstation for image display. The controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.
1
1
Image /page/1/Picture/0 description: The image shows the word "PLANAR" in a stylized, futuristic font. The letters are bold and angular, with sharp edges and diagonal lines giving it a modern and technological feel. The word appears to be a logo or brand name, possibly for a technology company or product.
Indications for Use: 21 CFR 807 92(a)(5)
The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C3 Color™ and C3 Gray™ are intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.
Technological Characteristics: 21 CFR 807 92(a)(6)
The device is an imaqe display system consisting of computer software and components. The device does not contact the patient, nor does it control any life sustaining devices. A physician or trained medical practitioner provides ample opportunity for competent human intervention to interpret images and information being displayed.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for the DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C3 Color™ and C3 Gray™ contain adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
The Planar Systems, Inc., DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™. Models C3 Color"M and C3 Gray™ will be manufactured by in accordance with voluntary and safety standards.
The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor.
2
Image /page/2/Picture/1 description: The image shows a black and white logo of the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing left and is enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written around the top half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 1 2003
Planar Systems, Inc. % Mr. Ned Devine, Jr. Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548
Re: K032638
Dated: August 1, 2003 Received: August 27, 2003
Trade/Device Name: DOME CXTM Digital Flat-Panel Display System™ Models C3 Color™ and C3 GrayTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ
Dear Mr. Devine:
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 adultcration.
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.
3
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
4
(Indications for Use Form)
510(k) Number: Ku3 2638
Device Name:
DOME CX™ DIGITAL FLAT-PANEL. DISPLAY SYSTEM™, Models C3 Color™ and C3 Gray™ from Planar Systems, Inc.
Indications for Use:
The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C3 Color™ and C3 Gray™ are intended to be used in displaying and viewing medical 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
--
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Manyc Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032638