(243 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 medical display monitor used for viewing and analyzing medical images. It does not directly treat or diagnose a disease or condition.
Yes
The device is a medical monitor intended for displaying, reviewing, and analyzing digital medical images, specifically for mammography applications, to aid trained medical practitioners in their review and analysis of images for diagnosis.
No
The device description clearly states "CX50N LCD Monitor System" and "CX50N LCD Monitor," indicating a hardware component (the monitor). While it includes calibration software (EzCal ver.2), the primary device being described and tested is the physical monitor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. The description of the CX50N LCD Monitor System clearly states its purpose is to display and view digital medical images for review and analysis. It does not interact with or analyze biological specimens.
- The intended use and device description focus on image display and calibration for medical imaging applications. This is a crucial distinction from the analytical function of an IVD.
- There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
The device is a medical image display system, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
CX50N 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.
Product codes
PGY
Device Description
CX50N 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.
CX50N 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
Digital medical images (Digital mammography, digital breast tomosynthesis).
Anatomical Site
Breast
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: Bench tests.
Sample Size: Not specified.
Key Results: The bench tests below were performed on the CX50N 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. The results of these tests demonstrate that CX50N meets the acceptance criteria and is adequate for this intended use.
No clinical studies were considered necessary and performed.
Key Metrics
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).
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Image /page/0/Picture/0 description: The image contains 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
WIDE Corporation % Mr. Josh Baker Consultant OT Consulting Inc. 33781 Bayside Lane DANA POINT CA 92629
Re: K222719
May 9, 2023
Trade/Device Name: CX50N Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: September 8, 2022 Received: September 8, 2022
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 Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222719
Device Name CX50N
Indications for Use (Describe)
CX50N 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 specifical mammography applications and digital breast tomosynthesis applications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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: K222719
[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
- Date Prepared [21 CFR 807.92(a) (1)]
- 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: | CX50N |
|---|---|
| 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: K170783 WIDE Corporation Applicant:
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| Model Name: | CX50N(CX50YQS) |
|---|---|
| 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)]
CX50N 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.
CX50N 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)]
CX50N 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 (CX50N) and the predicate device (K170783):
| Attributes | Predicate Device | Subject Device | Discussion of
Differences |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Product | CX50N(CX50YQS) | CX50N | - |
| Intended Use | The CX50N(CX50YQS)
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. | CX50N 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 | 1,150 cd/m² | Provided by the panel
manufacturers. |
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| Contrast Ratio | 1500 : 1 | 2000 : 1 | Provided by the panel
manufacturers. |
|-------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Input signal | DVI-I, DisplayPort | DVI-I, DisplayPort | - |
| Power Supply | 100240 VAC, 50/60Hz | 100240 VAC, 50/60Hz | - |
| Color/Monochrome | Color | Color | - |
| QC software | Lumical Advanced | EzCal | It is only a difference
in terms of each QC
software, but the
functions are similar. |
| Firmware | Version: N1220_221229 | Version: N1220_221229 | No change of the
firmware. |
| 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 CX50N device is an updated version of the predicate CX50N (CX50YQS) for the max luminance (from 1,200cd/m2 to 1,150cd/m2) with the improvement of the contrast ratio (from 1,500:1 to 2,000:1). The rest of design features, usability, safety and effectiveness are same.
-
- Summary of Non-Clinical Data
CX50N comply with the following international and FDA-recognized consensus standards:
- Summary of Non-Clinical Data
| 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 bench tests below were performed on the CX50N 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
No clinical studies were considered necessary and performed.
- Summary of Clinical Data
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10. 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 CX50N 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.