(66 days)
Not Found
No
The summary describes a monitor system for displaying medical images and mentions standard display performance metrics, with no indication of AI/ML processing or analysis of the images themselves.
No
The product is described as a monitor system used for displaying and viewing medical images. It does not perform any therapeutic function.
No
The device is a monitor system intended for displaying and viewing digital medical images, not for performing diagnostic analysis itself. It displays images for review by medical practitioners, but it does not process or interpret the images to provide a diagnosis.
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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The MX30N(MX30TQS) LCD Monitor System is described as a display system for viewing and analyzing digital medical images. It does not perform any tests on biological samples.
- Intended Use: The intended use is for displaying and viewing medical images for review and analysis by medical practitioners. This is a display and visualization function, not an in vitro diagnostic test.
- Device Description: The description focuses on the monitor and graphic control board for displaying images from a PACS workstation.
- Performance Studies: The performance studies mentioned are related to image display quality (resolution, luminance, contrast, noise), not the accuracy of a diagnostic test on a biological sample.
Therefore, the MX30N(MX30TQS) LCD Monitor System falls under the category of a medical image display device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MX30N(MX30TQS) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. The display is not intended for mammography.
Product codes
PGY
Device Description
MX30N(MX30TQS) 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
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)
No clinical studies were considered necessary and performed.
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 MX30N(MX30TQS) 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.
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 image of three human profiles facing to the right, with flowing lines connecting them, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2016
WIDE Corporation % Mr. YeoJin Yun RA Manager 12 Wongomae-ro, Giheung-gu Yongin-si, Gyeonggi-do 17086 REPUBLIC OF KOREA
Re: K160346
Trade/Device Name: MX30N(MX30TOS) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: February 5, 2016 Received: February 8, 2016
Dear Mr. Yun:
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 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.
1
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.
Michael D.'Hara
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) K160346
Device Name MX30N(MX30TQS)
Indications for Use (Describe)
The MX30N(MX30TQS) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. The display is not intended for mammography.
Type of Use (Select one or both, as applicable)
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)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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: | MX30N(MX30TQS) |
|---|---|
| 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: K032174 |
|---|
| Applicant: WIDE Corporation. |
| Model Name: WIDE 3MP TFT LCD MONITOR |
| 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)]
MX30N(MX30TQS) 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)]
MX30N(MX30TQS) is intended to be used to display and view digital medical images for review and analysis by trained medical practitioners. The display is not intended for mammography.
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 | K032174 |
| Model Name | MX30N(MX30TQS) | WIDE 3MP TFT LCD |
| MONITOR | ||
| Manufacturer | WIDE Corporation. | |
| 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 | MX30N(MX30TQS) is intended | |
| to be used in displaying and | ||
| viewing digital medical images for | ||
| review and analysis by trained | ||
| medical practitioners. The display | ||
| is not intended for mammography. | The WIDE 3MP TFT LCD | |
| monitor intended to be used in | ||
| displaying and viewing digital | ||
| medical images for review and | ||
| analysis by trained | ||
| medical practitioners | ||
| LCD Panel Size | 21.3" | 21.3" |
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
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| Parameter | Subject Device | Predicate Device |
|---|---|---|
| Resolution | $2048\times1536$ | $2048\times1536$ |
| Pixel pitch | 0.21075mm x 0.21075mm | 0.21mm x 0.21mm |
| Brightness | 1700cd/m² | 800 cd/m² |
| Contrast Ratio | 1400 : 1 | 600:1 |
| Input Signal | DVI-I, DisplayPort | DVI-D |
| Power Supply | 100~240 VAC, 50/60Hz | 100~240 VAC, 50/60Hz |
| Color/Monochrome | Monochrome | Monochrome |
When compared to the predicate devices (K032174), the MX30N(MX30TQS) 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
- Input Signal
9. Summary of Non-Clinical Data
MX30N(MX30TQS) 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.
10. Summary of Clinical Data
No clinical studies were considered necessary and performed.
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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 MX30N(MX30TQS) 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.