(54 days)
Not Found
No
The document describes a medical monitor and calibration software, with no mention of AI or ML capabilities. The performance studies focus on display characteristics.
No.
This device is an LCD monitor system intended for displaying and viewing digital medical images for review and analysis by trained medical practitioners, which falls under diagnostic imaging rather than therapy.
No
The device is a medical monitor designed for displaying and viewing digital medical images for review and analysis. While it is used by medical practitioners for analyzing images, it does not itself perform any diagnostic function; rather, it is a display tool. The 'Intended Use' specifically states it is for "displaying and viewing" images, and the 'Device Description' reiterates its purpose for "displaying, reviewing, and analysis of medical images." It facilitates the diagnostic process carried out by the medical practitioner, but it is not a diagnostic device in itself.
No
The device description clearly states it is a "Medical Monitor" (CX30N/CX30PQX), which is a hardware component. While it includes calibration software (EzCal ver.2), the primary device being cleared is the monitor itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this monitor is for displaying and viewing digital medical images for review and analysis. It does not interact with or analyze biological samples.
- The device's function is to display images. While it's used in a medical context for reviewing diagnostic images, its role is as a display device, not a tool for performing a diagnostic test on a biological sample.
- The performance studies focus on display characteristics. The tests performed (Pixel Defects, Luminance, Resolution, etc.) are related to the quality and performance of the display itself, not the accuracy of a diagnostic test on a biological specimen.
Therefore, the CX30N(CX30PQX) LCD Monitor System falls under the category of a medical image display device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CX30N(CX30PQX) 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
CX30N(CX30PQX) 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.
CX30N(CX30PQX) is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.
CX30N is basic model and CX30PQX is identical to CX30N, except model name.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital medical images
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
The bench tests below were performed on the CX30N(CX30PQX) 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, Resolution, Noise, Veiling Glare, Color Uniformity, Luminance Response, Luminance at 30° and 45° in diagonal, horizontal, and vertical directions, Temporal Performance test, Color Tracking, Gray Tracking. No clinical studies were considered necessary and performed. The effectiveness of the device was validated through bench tests. The results of these tests demonstrate that CX30N(CX30PQX) meets the acceptance criteria and is adequate for this intended use.
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).
0
April 14, 2021
Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Wide Corporation % Mr. YeoJin Yun RA Manager 15F, The First Tower III, 602, Dongtangiheung-Ro Hwaseong-Si. Gyeonggi-Do 18469 REPUBLIC OF KOREA
Re: K210493
Trade/Device Name: CX30N (CX30PQX) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: January 11, 2021 Received: February 19, 2021
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. 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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210493
Device Name CX30N(CX30PQX)
Indications for Use (Describe)
The CX30N(CX30PQX) 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) |
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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)]
03/16/2021
2. 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 |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)|
Model Name: CX30N(CX30PQX) TFT LCD Medical Monitor System Common Name: 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: | K153354 |
|---|---|
| Applicant: | EIZO CORPORATION |
| Model Name: | 3MP Color LCD Monitor, RadiForce RX350 |
| Common Name: | TFT LCD Medical Monitor System |
| Classification Name: | Display, Diagnostic Radiology |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | PGY |
| Device Class: | 2 |
510(k) Summary 1/4
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5. Description of the Device [21 CFR 807.92(a) (4)]
CX30N(CX30PQX) 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.
CX30N(CX30PQX) is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.
CX30N is basic model and CX30PQX is identical to CX30N, except model name.
6. Intended Use [21 CFR 807.92(a) (5)]
CX30N(CX30PQX) 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.
| Attributes | Predicate Device | Subject Device | Discussion
of
Differences |
|----------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------|
| Product | RadiForce RX340 | CX30N(CX30PQX) | - |
| Screen
technology | IPS TFT Color LCD
Panel | Dual domain IPS TFT
Color LCD Panel | - |
| Viewing
angle (H, V) | H: 170°, V: 170° | H: 178°, V: 178° | Provided by the panel
manufacturers. |
| Active screen
size | 323.7 mm x 431.6 mm | 324.86 mm x 433.15 mm | Provided by the panel
manufacturers. |
| Resolution | 3MP (1,536 x 2,048) | 3MP (1,536 x 2,048) | - |
| Aspect ratio | 3 : 4 | 3:4 | - |
| Pixel pitch | 0.21075 mm x 0.21075
mm | 0.2115 mm x 0.2115
mm | Provided by the panel
manufacturers. |
| Maximum
luminance | 1,000 cd/m² | 1,000 cd/m² | - |
| DICOM
calibrated
luminance | 400 cd/m² | 450 cd/m² | Differences by
manufacturers. |
| Contrast ratio | 1400 : 1 | 1500 : 1 | Provided by the panel
manufacturers. |
| Backlighting | LED | LED | - |
| Display
Colors | From a palette of 68
billion colors:
- 10-bit input
(DisplayPort): 1.07 | From a palette of 68
billion colors: - 10-bit input
(DisplayPort): 1.07 | - |
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
510(k) Summary 2/4
5
| | billion colors
(maximum)
- 8-bit input: 16.77
million colors | billion colors
(maximum) - 8-bit input: 16.77
million colors | |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Luminance
non-uniformity
compensation | Digital Uniformity
Equalizer | Luminance
Uniformity
Control | It is only a difference in
terms of each
manufacturer, but the
functions are similar. |
| Input video
signals | DVI-D (dual link) x 1,
DisplayPort x 1 | DVI-D (dual link) x 1,
DisplayPort x 1 | - |
| Scanning
Frequency
(H, V) | 31 - 127 kHz, 29 - 61
Hz
(VGA Text: 69 - 71 Hz)
Frame synchronous
mode: 29.5 - 30.5 Hz,
59 - 61 Hz | 96KHz, 60Hz | Differences by
manufacturers. |
| Power
Requirements | AC 100 - 120 V,
200 - 240 V: 50 / 60 Hz | AC 100~240 V: 50 / 60
Hz
DC +24V, 2.4A | Differences by
manufacturers. |
| Power
Consumption
/ Save Mode | 125 W / Less than 3 W | 75 W / Less than 2 W | Differences by
manufacturers. |
| Power
Management | DVI DMPM,
DisplayPort 1.1a | DVI DMPM,
DisplayPort 1.1a | - |
| QC software | RadiCS | EzCal | It is only a difference in
terms of each
manufacturer, but the
functions are similar. |
| Sensors | Backlight Sensor,
Presence Sensor,
Integrated Front
Sensor,
Ambient Light Sensor | Backlight Sensor,
IQ Sensor,
Ambient Light Sensor | It is only a difference in
terms of each
manufacturer, but the
functions are similar.
but Integrated Front
Sensor is not used. |
| USB Ports /
Standard | 1 upstream,
2 downstream / Rev.
2.0 | 1 upstream,
3 downstream / Rev.
3.0 | Differences by
manufacturers. |
| Dimensions
w/o stand
(W x H x D) | 376 x 505 x 98 mm | 366 x 476 x 65.5 mm | Different housing
design due to the
different panel size |
CX30N(CX30PQX) Device is substantially equivalent to the currently marketed and predicate devices in terms of design features, indications for use, and safety and effectiveness.
9. Summary of Non-Clinical Data
CX30N(CX30PQX) 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 - |
| 510(k) Summary 3/4 | |
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Requirements And Tests
The bench tests below were performed on the CX30N(CX30PQX) 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, Resolution, Noise, Veiling Glare, Color Uniformity, Luminance Response, Luminance at 30° and 45° in diagonal, horizontal, and vertical directions, Temporal Performance test, Color Tracking, Gray Tracking
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, 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 CX30N(CX30PQX) 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.