(84 days)
Not Found
No
The summary describes a monitor system for displaying medical images and does not mention any AI/ML capabilities for image analysis or processing.
No
The device is described as an LCD monitor system for displaying images, not for treating a disease or condition.
No
The device is described as an LCD monitor system used for displaying and viewing digital medical images for review and analysis, not for directly performing diagnostic interpretations or generating diagnostic data itself. It displays the output of other diagnostic devices.
No
The device description explicitly states it consists of a "flat panel hi-resolution 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:
- 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The MX50T(MX50TQS) LCD Monitor System is a display device. Its purpose is to show digital medical images (specifically mammography and breast tomosynthesis) for review and analysis by medical practitioners. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for "displaying and viewing digital medical images." This is a function related to image presentation, not diagnostic testing of biological material.
Therefore, while it's a medical device used in the diagnostic process (by displaying images for interpretation), it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MX50TQS) LCD Monitor 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 and breast tomosynthesis applications.
Product codes
PGY
Device Description
MX50T(MX50TQS) is a flat panel hi-resolution LCD monitor system for displaying digital 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 image display. The WIDE controller board is installed into the PACS workstation computer or other computer system 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 / Not Found
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)
The safety of the subject device was validated through tests including IEC60601-1 and IEC 60601-1-2. The effectiveness of the device was validated through tests for resolution, luminance, contrast and noise. The tests conducted for resolution, luminance, contrast and noise all met the acceptance criteria specified in the standards.
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
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 graphic of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19th, 2016
WIDE Corporation % Mr. YeoJin Yun RA Manager 12 Wongomae-Ro, Giheung-Gu Yongin-Si. Gyeonggi-Do 17086 REPUBLIC OF KOREA
Re: K160354 Trade/Device Name: MX50T(MX50TQS) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: February 5, 2016 Received: April 7, 2016
Dear Mr. Yun:
This letter corrects our substantially equivalent letter of May 2, 20016.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jeff Rodriquez
for
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160354
Device Name MX50T(MX50TQS)
Indications for Use (Describe)
The MX50TQS) LCD Monitor 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 and breast tomosynthesis applications.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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510(k) Summary
[As required by 21 CFR 807.92]
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92
1. Date Prepared [21 CFR 807.92(a) (1)]
02/05//2016
2. Submitter's Information [21 CFR 807.92(a) (1)]
| Name of Sponsor: | WIDE Corporation. |
|---|---|
| Address: | 12 Wongomae-Ro, Giheung-Gu, Yongin-Si, Gyeonggi-Do |
| 17086, Republic of Korea | |
| Contact Name: | YeoJin Yun |
| Telephone #: | +82-31-218-1675 |
| Fax #: | +82-31-218-7400 |
| Email: | yyjin@widecorp.com |
| Registration Number: | 3004082357 |
| Name of Manufacturer: | Same as Sponsor |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]
| Model Name: | MX50T(MX50TQS) |
|---|---|
| Common Name: | TFT LCD Medical Monitor System |
| Classification Name: | Display, Diagnostic Radiology |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | PGY |
| Device Class: | 2 |
| Review Panel: | Radiology |
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
| 510(k) Number: | K103792 |
|---|---|
| Applicant: | BARCO NV. |
| Model Name: | BARCO MAMMO TOMOSYNTHESIS |
| Common Name: | TFT LCD Medical Monitor System |
| Classification Name: | System, Image Processing, Radiological |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Device Class: | 2 |
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5. Description of the Device [21 CFR 807.92(a) (4)]
MX50T(MX50TQS) is a flat panel hi-resolution LCD monitor system for displaying digital 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 image display. The WIDE controller board is installed into the PACS workstation computer or other computer system to display PACS medical images.
6. Intended Use [21 CFR 807.92(a) (5)]
The MX50TQS) LCD Monitor 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 and breast tomosynthesis applications.
7. Technological Characteristics [21 CFR 807.92(a) (6)]
The device is an image display system which consists 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.
| Parameter | Subject Device | Predicate Device |
|---|---|---|
| 510(k) Number | Unknown | K103792 |
| Model Name | MX50T(MX50TQS) | BARCO MAMMO |
| TOMOSYNTHESIS | ||
| Manufacturer | WIDE Corporation. | BARCO NV. |
| Common Name | TFT LCD Medical Monitor System | |
| Classification Name | Display, Diagnostic Radiology | System, Image Processing |
| Radiological | ||
| Classification Panel | Radiology | |
| Classification Regulation | 21 CFR 892.2050 | |
| Product Code | PGY | LLZ |
| Device Class | Class II | |
| Intended Use | The MX50T(MX50TQS) LCD | |
| Monitor 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 and | ||
| breast | ||
| tomosynthesis | The Barco Mammo | |
| Tomosynthesis (MIDMVG-5221) | ||
| device is intended to be used in | ||
| displaying and viewing digital | ||
| images, including standard and | ||
| multi-frame digital | ||
| mammography, for review, | ||
| analysis, and diagnosis by trained | ||
| medical practitioners. It is |
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
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| Parameter | Subject Device | Predicate Device |
|---|---|---|
| applications. | specially designed for breast | |
| tomosynthesis applications. | ||
| LCD Panel Size | 21.3" | 21.3" |
| Resolution | 2560 × 2048 | 2560 × 2048 |
| Pixel pitch | 0.165mm x 0. 165mm | 0.165mm x 0. 165mm |
| Brightness | 2000cd/m² | 2,100cd/m² |
| Contrast Ratio | 1000 : 1 | 950:1 |
| Input Signal | DVI-I, DisplayPort | DVI-I |
| Power Supply | 100~240 VAC, 50/60Hz | 100~240 VAC, 50/60Hz |
| Color/Monochrome | Monochrome | Monochrome |
When compared to the predicate devices (K103792), the MX50T(MX50TQS) presented in this submission has the same of the followings:
- Intended Use
- Technological characteristics
- LCD Panel Size
- Resolution
- Pixel pitch
The two devices share the similar performance as the following:
- · Brightness
- Contrast Ratio
9. Summary of Non-Clinical Data
MX50T(MX50TQS) comply with the following international and FDA-recognized consensus standards:
| IEC 60601-1: | Medical Electrical Equipment -- Part 1: General
Requirements For Basic Safety And Essential Performance |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2: | Medical Electrical Equipment - Part 1-2: General
Requirements For Basic Safety And Essential Performance -
Collateral Standard: Electromagnetic Compatibility -
Requirements And Tests |
The tests conducted for resolution, luminance, contrast and noise all met the acceptance criteria specified in the standards.
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10. Summary of Clinical Data
No clinical studies were considered necessary and performed.
11. Conclusion [21 CFR 807.92(b) (3)]
Subject Device is substantially equivalent to the currently marketed and predicate devices in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
Additionally, the safety of the subject device was validated through tests including IEC60601-1 and IEC 60601-1-2. The effectiveness of the device was validated through tests for resolution, luminance, contrast and noise.
The results of these tests demonstrate that MX50T(MX50TQS) meets the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, non-clinical performance data, safety testing demonstrates that the device is as safe and effective as the predicate device and performs as well as the predicate device.