(242 days)
Not Found
No
The document describes a medical monitor and calibration software, with no mention of AI or ML capabilities for image analysis or processing beyond display and calibration.
No.
The device is a monitor system for displaying and analyzing medical images. It does not provide any treatment or therapy.
No
The device is a monitor system intended for displaying medical images for review and analysis, not for performing diagnostic analysis itself. It is a tool for diagnostic professionals, but does not provide diagnosis.
No
The device description clearly states that the primary device is an "MX50N LCD Monitor System," which is a hardware component (a monitor). While it includes calibration software (EzCal ver.2), the core device being cleared is the monitor itself, not just the software. The performance studies also focus on the physical characteristics of the monitor.
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.
- Device Function: The MX50N LCD Monitor System is a display device. Its purpose is to show digital medical images for review and analysis. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for "displaying digital medical images for review and analysis."
- Device Description: The description reinforces that it's a "high resolution color and grayscale medical imaging for PACS and Radiology system."
- Input: The input is "Digital medical images," not biological samples.
While the device is used in a medical context and is crucial for interpreting diagnostic images (which are often generated from IVD procedures or other diagnostic modalities), the monitor itself is not performing an in vitro diagnostic test. It's a tool for viewing the results of such tests or other imaging procedures.
N/A
Intended Use / Indications for Use
MX50N LCD Monitor System is intended to be used in displaying digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications and digital breast tomosynthesis applications.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
MX50N LCD Monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images.
EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.
MX50N is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Breast (for mammography and digital breast tomosynthesis applications)
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were performed on the MX50N following the instructions in 'Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017.
Test Item: Pixel Defects, Artifacts, Luminance, Reflection, Luminance Uniformity, Veiling Glare, Color Uniformity, Luminance Response, Luminance at 30° and 45° in horizontal, and vertical directions, Temporal Performance Test, Color Tracking, Gray Tracking, MTF.
No clinical studies were considered necessary and performed.
The results of these tests demonstrate that MX50N meets the acceptance criteria and is adequate for this intended use.
The effectiveness of the device was validated through bench tests.
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.
Not Found
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
WIDE Corporation % Mr. Josh Baker Consultant OT Consulting 33781 Bayside Lane DANA POINT CA 92629
Re: K222716
May 8, 2023
Trade/Device Name: MX50N Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: March 17, 2023 Received: March 20, 2023
Dear Mr. Baker:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality
Enclosure
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Indications for Use
510(k) Number (if known) K222716
Device Name MX50N
Indications for Use (Describe)
MX50N LCD Monitor System is intended to be used in displaying digital medical images for review and analysis by trained medical practitioners. It is specifical mammography applications and digital breast tomosynthesis applications.
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) |
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510(k) Summary Submission number: K222716
[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
- Date Prepared [21 CFR 807.92(a) (1)]
06/13/2022
- Submitter's Information [21 CFR 807.92(a) (1)]
| Name of Sponsor: | WIDE Corporation. | |
|---|---|---|
| Address: | 15F, The First Tower III, 602, Dongtangiheung-Ro, | |
| Hwaseong-Si, Gyeonggi-Do 18469, Republic of Korea | ||
| Contact Name: | YeoJin Yun | |
| Telephone #: +82-31-218-1675 | ||
| Fax #: +82-31-376-9600 | ||
| Email: yyjin@widecorp.com | ||
| Registration Number: | 3004082357 | |
| Name of Manufacturer: | Same as Sponsor | |
| 510(k) Contact Person | Josh Baker – Consultant, OT Consulting Inc. | |
| 33781 Bayside Lane, Dana Point, California 92629 USA | ||
| Tel: 714-788-8152 | ||
| Email: josh@otconsulting.tech |
- Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]
| Model Name: | MX50N |
|---|---|
| Common Name: | TFT LCD Medical Monitor System |
| Classification Name: | Medical image management and processing system |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | PGY |
| Device Class: | 2 |
| Review Panel: | Radiology |
- Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
510(k) Number: K170781 WIDE Corporation Applicant: Model Name: MX50N(MX50YQS)
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| Common Name: | TFT LCD Medical Monitor System |
|---|---|
| Classification Name: | Picture archiving and communications system |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | PGY |
| Device Class: | 2 |
- Description of the Device [21 CFR 807.92(a) (4)]
MX50N LCD Monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images.
EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.
MX50N is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.
- Intended Use [21 CFR 807.92(a) (5)]
MX50N 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 digital breast tomosynthesis applications.
- Technological Characteristics [21 CFR 807.92(a) (6)]
The table below presents comparisons between the subject device (MX50N) and the predicate device (K170781):
| Attributes | Predicate Device | Subject Device | Discussion of Differences |
|---|---|---|---|
| Product | MX50N(MX50YQS) | MX50N | - |
| Intended Use | The MX50N | ||
| (MX50YQS) 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 digital | |||
| breast tomosynthesis | |||
| applications. | MX50N 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 digital | |||
| breast tomosynthesis | |||
| applications. | - | ||
| Response Time (typical) | 25ms (On/Off) | 25ms (On/Off) | - |
| LCD Panel size | 21.3" | 21.3" | - |
| Resolution | 2560 x 2048 | 2560 x 2048 | - |
| Pixel pitch | 0.165 mm x 0.165mm | 0.165 mm x 0.165mm | - |
| Maximum luminance | 1,200 cd/m2 | 3,000 cd/m2 | Provided by the panel |
| manufacturers. |
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| Contrast Ratio | 1000 : 1 | 2000 : 1 | Provided by the panel manufacturers. |
|---|---|---|---|
| Input signal | DVI-I, DisplayPort | DVI-I, DisplayPort | - |
| Power Supply | 100~240 VAC, 50/60Hz | 100~240 VAC, 50/60Hz | - |
| Color/Monochrome | Monochrome | Monochrome | - |
| Firmware | Version: N1220_221229 | Version: N1220_221229 | No change of the firmware. |
| QC software | Lumical Advanced | EzCal | It is only a difference in terms of each QC software, but the functions are similar. |
| Luminance Non-uniformity compensation | Luminance Uniformity Correction | Luminance Uniformity Correction | - |
| Sensors | Backlight Sensor, | ||
| IQ Sensor, | |||
| Ambient Light Sensor | Backlight Sensor, | ||
| IQ Sensor, | |||
| Ambient Light Sensor | - | ||
| USB Ports / Standard | 1 upstream, | ||
| 3 downstream / Rev. 3.0 | 1 upstream, | ||
| 3 downstream / Rev. 3.0 | - | ||
| Dimensions (w stand) | |||
| (W x H x D) | 390.3 x 520.1 x 248.8 mm | 390.3 x 520.1 x 248.8 mm | - |
The subject monitor model MX50N device is an improved version of the predicate MX50N (MX50YQS) for the max luminance (from 1,200cd/m2) and the contrast ratio (from 1,000:1 to 2,000:1). The rest of design features, usability, safety and effectiveness are same.
- Summary of Non-Clinical Data
MX50N 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 Electrical Equipment - Part 1-2: General IEC 60601-1-2: Medical Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests
The bench tests below were performed on the MX50N following the instructions in 'Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017.
• Test Item
Pixel Defects, Artifacts, Luminance, Reflection, Luminance Uniformity, Veiling Glare, Color Uniformity, Luminance Response, Luminance at 30° and 45° in horizontal, and vertical directions, Temporal Performance Test, Color Tracking, Gray Tracking, MTF
- Summary of Clinical Data
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No clinical studies were considered necessary and performed.
- 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 bench tests.
The results of these tests demonstrate that MX50N 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.