(15 days)
Not Found
No
The document describes a medical display monitor and does not mention any AI or ML capabilities.
No
This device is a display monitor for medical images, not a device that provides therapeutic treatment. Its purpose is for review and analysis by practitioners for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" states that the device is "intended to use in displaying images for review and analysis by trained medical practitioner for diagnose". This directly indicates its role in the diagnostic process.
No
The device description explicitly states it is a "2MP Medical Monochrome Reference Display," which is a hardware component (a monitor). The intended use also describes displaying images, which is the function of a display device.
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 medical images (CT, MRI, HIS, PACS) for review and analysis by trained medical practitioners for diagnosis. This is a function related to medical imaging and interpretation, not the analysis of biological samples or substances from the human body.
- Device Description: It's described as a "Medical Monochrome Reference Display," which is a display device for viewing images.
- Input Imaging Modality: The input modalities are imaging systems (CT, MRI, PACS), not laboratory tests or biological sample analysis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to display images generated by other medical imaging equipment.
N/A
Intended Use / Indications for Use
2 MP Medical Monochrome Reference Display, MDM2130-2NC 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 Mammography Digital System.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
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Mentions image processing
System, Image Processing, Radiological
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioner
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
MDM1900-1NG 19" Monochrome Medical Display by CHI LIN Technology CO., LTD. (K061303).
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.
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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
Koco 3289
1.0 General Information
NOV 1 6 2006
:
.
| Name and address of manufacturer: | CHI LIN Technology CO., LTD.
No.71, Te Lun Road, Jen Te Hsian,
Tainan County 717, Taiwan, R.O.C. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Registration Number: | Unknown (still under processing) |
| Contact Person: | Mr. Phil Chen
Ph: +886-6-279 - 4113 ext. 533
Facsimile: +886-6-249 - 4751 |
| Device Trade Name: | 2MP Medical
Monochrome Reference Display -
MDM2130-2NC. |
| Device Common Name: | Monochrome LCD Monitor, Monochrome
Diagnostic Display, etc. |
| Classification of the Device: | System, Image Processing, Radiological
(CLASS II CFR 892.2050) |
| Intended Use: | 2 MP Medical Monochrome Reference
Display, MDM2130-2NC 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
Mammography Digital System. |
| Predicate SE Device: | MDM1900-1NG 19" Monochrome
Medical Display by CHI LIN Technology
CO., LTD. (K061303). |
1
Standards:
2 MP Medical Monochrome Reference Display, MDM2130-2NC has met the following standards: Safety 60601-1, EMC - EN 60601-1-2, ITE Safety/EMC – EN 60950-1, CE, FCC. It also meets CDRH recognized voluntary standard – DICOM (please refer to Appendix A for DICOM conformance statement and certificates, and Appendix B for other certificates and reports of other standards).
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 stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three vertical lines that curve and resemble a stylized bird or wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
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
NOV 1 6 2006
Re: K063289
Trade/Device Name: Medical Display, MDM2130-2NC Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 25, 2006 Received: November 1, 2006
Dear Mr. Mouser:
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image is a circular logo or seal. The text "1906-2006" is at the top of the circle. The letters "FDA" are in the center of the circle in a stylized font. Below the letters, the word "Centennial" is written in cursive. Three stars are at the bottom of the logo.
Protecting and Promoting Public Health
3
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C.Bogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Medical Display, MDM2130-2NC
Indications For Use: 2MP Medical Monochrome Reference Display, MDM2130-2NC 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.
Prescription Use (Part 21 CFR 801 Subpart D)
ANDIOR
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)
David h. Stenson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .