(15 days)
Not Found
No
The document describes a medical display monitor with standard features for image display and calibration, and there is no mention of AI or ML capabilities.
No
The device is a display monitor used for reviewing and analyzing images, not for directly treating or diagnosing medical conditions. It serves as a tool for medical practitioners to aid in diagnosis but does not perform therapeutic functions itself.
Yes
The device is a medical display intended for review and analysis of images by trained medical practitioners for "diagnose in CT, MRI, HIS and PACS," which are diagnostic imaging modalities and systems. While the display itself doesn't perform diagnosis, it is a crucial component in the diagnostic process.
No
The device description explicitly states it is a "19" color LCD monitor" and provides hardware specifications like resolution and screen size, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS." This describes a device used for viewing and interpreting medical images, which are typically generated from imaging modalities like CT and MRI.
- 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. This device does not perform any such tests on biological samples.
- Device Description: The device is described as a "color LCD monitor that displays image for medical use." This aligns with the function of a display device for medical imaging, not an IVD.
- Regulation Classification: The device is classified under "System, Image Processing, Radiological (CLASS II CFR 892.2050)". This classification is for devices used in processing and displaying radiological images, not for in vitro diagnostic tests.
Therefore, the primary function and intended use of this device are related to displaying medical images for diagnostic interpretation, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
Medical Display, MDC1900-1LG, Indications For Use; MDC1900-ILR is intended to use in displaying images for review and analysis by MDC1900-11LR Is intended to use in displaying anages and CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
Product codes
LLZ
Device Description
1.3MP Medical Color Reference Display, MDC1900-1LG (ILR) is a 19" color LCD monitor that displays image for medical use. It provides 1.3 mega pixel (1280 x 1024/1024 x 1280) resolution and enable the user to define desired DICOM GSDF Gamma settings such as 1.8, 2.0, 2.2 and 2.4 for more precise diagnose use in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
CT, MRI, HIS and PACS
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
displaying images for review and analysis by trained medical practitioner
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)
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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
MAY 2 5 2006
K06/305
510(K) Summary of Safety and Effectiveness
As required by 807.92
DEVICE ESTABLISHMENT AND CONTACT PERSON
Phil Chen CHILIN TECHNOLOGY CO. LTD No.71, Te Lun Road, Jen Te Hsian, Tainan County 717, Taiwan, R.O.C. Ph: +886-6-279 - 4113 ext. 533 Facsimile: +886-6-249 - 4751
DATE SUMMARY PREPARED
14 December 2005
DEVICE NAME
Trade Name: 1.3MP Medical Color Reference Display, MDC1900-1LG MDC1900-1LR Common Name: Color LCD Monitor, Color Diagnostic Display, etc. Classification Name: System, Image Processing, Radiological (CLASS II CFR 892.2050)
PREDICATE DEVICE
RadiForce R12 19" Class Color LCD Monitor by EIZO NANAO CORPORATION (K040982)
DEVICE DESCRIPTION
1.3MP Medical Color Reference Display, MDC1900-1LG (ILR) is a 19" color LCD monitor that displays image for medical use. It provides 1.3 mega pixel (1280 x 1024/1024 x 1280) resolution and enable the user to define desired DICOM GSDF Gamma settings such as 1.8, 2.0, 2.2 and 2.4 for more precise diagnose use in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
DEVICE OF INTEND USE
1.3MP Medical Color Reference Display, MDC1900-1LG (ILR) is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
1
CONCLUSION
1.3MP Medical Color Reference Display, MDC1900-1LG (1LR) has the same intended use as the predicate device R12, and they both share the similar characteristics except some minor differences which do not raise new questions of safety and effectiveness. The device does not contact with the patient nor does it control any life sustaining device. Therefore we concluded that it is substantially equivalent to R12 by EIZO NANAO CORPORATION (K040982).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings outstretched, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2006
Chilin Technology Co., LTD % Mr. Marc M. Mouser Senior Project Engineer, Program Reviewer Underwriters Laboratories, Inc. 2600 N.W Lake Road CAMAS WA 98607-8542
Re: K061305
Trade/Device Name: Medical Display, MDC1900-1LG (1LR) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 27, 2006 Received: May 10, 2006
Dear Mr. Mouser:
This letter corrects our substantially equivalent letter of May 25, 2006.
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 (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 may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/12 description: The image shows a circular logo with the letters 'FDA' in a stylized font at the center. Above the letters, there are some smaller words that are difficult to read due to the image quality. Below the letters, the word 'Centennial' is visible. The entire logo is surrounded by a dotted circle, and there are some words along the perimeter of the circle, but they are also difficult to read.
Protecting and Promoting Public Health
3
Page 2 - Mr. Mouser
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 continue 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 (240) 276-0120. 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 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/cdrh/dsma/dsmamain.html
Sincerely yours,
David A. Stegerson
fm
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
510(k) Number (if known):
Device Name: Medical Display, MDC1900-1LG (ILR)
1.3MP Medical Color Reference Display, MDC1900-1LG, Indications For Use; MDC1900-ILR is intended to use in displaying images for review and analysis by MDC1900-11LR Is intended to use in displaying anages and CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Gordon
(Division Sign-Off) 0
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061305