(148 days)
Not Found
No
The description focuses on the display technology and graphic control board, with no mention of AI or ML capabilities for image analysis or processing beyond simple display.
No
The device is a display system for viewing medical images, not for treating any medical condition.
No
The device is a display system (monitor) for viewing digital medical images, not a diagnostic device itself. Its purpose is to present images for review and analysis by medical practitioners, who then perform the diagnostic task.
No
The device description explicitly states it consists of a "flat panel hiresolution LCD monitor system" and a "high-resolution graphic control board," which are hardware components.
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 medical images for review and analysis. This is a function related to medical imaging interpretation, not the analysis of biological samples (like blood, urine, or tissue) outside the body.
- Device Description: The device is a monitor system for displaying images. It does not involve reagents, calibrators, or other components typically associated with in vitro diagnostic tests.
- Lack of IVD-Specific Information: The document does not mention any aspects related to analyzing biological samples, detecting specific analytes, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to present existing medical images to a practitioner.
N/A
Intended Use / Indications for Use
The Lumimed Series 5MP Digital Flat Panel Display System ™ is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.
Product codes
LLZ
Device Description
Lumimed Series 5MP Digital Flat Panel Display System™ is a flat panel hiresolution LCD monitor system for displaying medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale and color 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
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital medical 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 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
510{k} Summary of Safety and Effectiveness
APR 2 5 2008
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared: November 25, 2007
Submitter's Information: 21 CFR 807.92(a)(1) Mr. K.S. Yun General Manager HeeYoung Co., Ltd. 048-8, Shin-Dong, Danwon-gu, Ansan City, Kyunggi-do 425-839 Korea Email: ykss@wooyoung.com.kr
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) Trade Name: Lumimed Series 5MP Digital Flat Panel Display System™ Common Name: Picture Archiving Communications System Device Classification: 892.2050 - LLZ Name: System, Image Processing
Predicate Device: 21 CFR 807. 92(a)(3)
| 510(k) Number | K031929 |
|---|---|
| Device Classification Name | system, image processing, radiological |
| Device Name | 5MP TFT LCD MONITOR SYSTEM |
| IF2105A | |
| Applicant | WIDE Corporation |
| Regulation Number | 892.2050 |
| Classification Product Code | LLZ |
| Decision Date | 07/08/2003 |
| Decision | substantially equivalent (SE) |
| Classification Advisory Committee | Radiology |
Device Description: 21 CFR 807 92(a)(4)
Lumimed Series 5MP Digital Flat Panel Display System™ is a flat panel hiresolution LCD monitor system for displaying medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale and color image display. The controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.
1
510(k) Summary of Safety and Effectiveness
Indications for Use: 21 CFR 807 92(a)(5)
The Lumimed Series 5MP Digital Flat Panel Display System ™ is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.
Technological Characteristics: 21 CFR 807 92(a)(6)
The device is an image 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 Lumimed Series 5MP Digital Flat Panel Display System ™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
The Lumimed Series 5MP Digital Flat Panel Display System ™ will be manufactured by HeeYoung Co., Ltd. in accordance with the voluntary and safety standards, i.e. Safety / Immunity UL2601-1/EN60601-1 / IEC601-1, FCC Class B. CE, VCC, UL 950, cUL2601-1, CE Mark EMC/IEC = VCCI, CE, MIC FCC Class B digital device, pursuant to Part 15.
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 logo for the Department of Health & Human Services (USA). The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three abstract shapes resembling an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
HeeYoung Co., Ltd. % Mr. Carl Alletto Consultant OTech, Inc. 1600 Manchester Way CORINTH TX 76210
Re: K073358
Trade/Device Name: Lumimed Series 5MP Digital Flat Panel Display System™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 19, 2008 Received: April 22, 2008
Dear Mr. Alletto:
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 vour 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.
3
Page 2
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.
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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.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
4
(Indications for Use Form)
510(k) Number:
Device Name: Lumimed Series 5MP Digital Flat Panel Display System™
Indications for Use:
The Lumimed Series 5MP Digital Flat Panel Display System ™ is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) X
OR
Over-The-Counter Use (Optional Format 1-2-96)
Division Sign-(Division of Reproductive, Abdominal, an Radiological Devices 510(k) Number
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