(27 days)
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No
The document does not mention AI, ML, deep learning, or any related terms, nor does it describe features or functionalities typically associated with AI/ML in medical imaging displays. The description focuses on the display's technical specifications and intended use for viewing images.
No
The device is a display monitor used for viewing diagnostic images; it does not directly treat or prevent a disease or condition.
Yes
The device is intended for "displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners." This explicitly states its purpose in diagnostic activities.
No
The device description explicitly states it is a "30" monochrome/color LCD display for medical image viewing. 4 Mega pixel medical grade LCD monitor," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "displaying and viewing digital images for diagnosis of X-ray or MRI, etc." This describes a device used to present medical images to a trained medical practitioner for interpretation.
- Device Description: The device is described as a "30" monochrome/color LCD display for medical image viewing." This is a display device, not a device that performs tests on biological samples.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with biological samples in this way.
The device is a medical image display, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
PACSmate MMD-4300C/4300CX is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. PACSmate MMD-4300C/4300CX does not support the display of mammography images for diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The PACSmate MMD-4300C/4300CX is a 30" monochrome/color LCD display for medical image viewing.4 Mega pixel medical grade LCD monitor with high resolutions.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray or MRI
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained medical practitioners
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)
bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness.
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.
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).
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§ 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).
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JUL - 7 2009
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
1. Submitter's Name: IEI Technology Corp. Address: No.29,Jhong-Sing Road, Si-Jhih City, Taipei County, 221, Taiwan Phone: +886-2-26902098 EXT: 18853 Fax: +886-2-26902099 Mr. Tom Chen Contact:
2. Device Name :
| Trade Name: | PACSmate |
|---|---|
| Model no.: | MMD-4300C/MMD-4300CX |
| Common Name: | Image display system, medical image workstation, image |
| monitor/display, and others | |
| Classification name | System, image processing, radiological |
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- DEVICE CLASS
The PACSmate MMD-4300C/4300CX has been classified ક્ષક Regulatory Class: II Panel: Radiology
Product Code: LLZ Regulation Number: 21CFR 892.2050
- The predicate device is the COLOR LCD MONITOR, 4. Predicate Device: FLEXSCAN MX300W (K073340) marketed by EIZO NANAO CORPORATION.
- PACSmate MMD-4300C/4300CX is intended to be used in 5. Intended Use: displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. PACSmate MMD-4300C/4300CX does not support the display of mammography images for diagnosis.
Product: PACSmate MMD-4300C/4300CX Section 4 - 510(k) Summary
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Section 4 – 510(k) Summary
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6. Device Description: The PACSmate MMD-4300C/4300CX is a 30" monochrome/color LCD display for medical image viewing.4 Mega pixel medical grade LCD monitor with high resolutions.
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- Performance In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards Summary: included IEC 60601-1 and IEC 60601-1-2 requirements.
8. Conclusions:
The PACSmate MMD-4300C/4300CX has the same intended use and similar technological characteristics as the COLOR LCD MONITOR, FLEXSCAN MX300W (K073340) marketed by EIZO NANAO CORPORATION. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, The PACSmate MMD-4300C/4300CX is substantially equivalent to the predicate devices.
Product: PACSmate MMD-4300C/4300CX Section 4 - 510(k) Summary Page 2 of 2
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2009
IEI Technology Corp. % Ms. Jennifer Reich Senior Consultant Harvest Consulting Corp. (USA) 2904 N. Boldt Drive FLAGSTAFF AZ 86001
Re: K091687
Trade/Device Name: PACSmate, Model No .: MMD-4300C/MMD-4300CX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 5, 2009 Received: June 10, 2009
Dear Ms. Reich:
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 (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); medical device reporting of medical
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/industry/support/index.html.
Sincerely vours
Shurly M. Morris
Janine M. Morris Acting 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: PACSmate Model No.: MMD-4300C/MMD-4300CX IEI Technology Corp.
Indications For Use:
PACSmate MMD=4300C/4300CX is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. PACSmate MMD-4300C/4300CX does not support the display of mammography images for diagnosis.
Prescription Use V (Parl 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division Rign Off
(Division Sign-Off) Division of Reproductive, Abdominal an Radiological Devices 510(k) Number
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