The CL24N LCD Monitor System is intended to be used in displaying digital medical images for review by trained medical practitioners. It does not support the display of mammography images for diagnosis.

Device Description

CL24N is intended to display high resolution color and gravscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying and reviewing of medical images.

EzCal is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.

EzCal is packed with the display.

While using the CL24N product, use the EzCal S/W provided as a bundle to periodically check whether the product meets the intended use.

If the product does not meet the intended use, the product must be returned to the manufacturer or an authorized service center to be calibrated to a product that can be used normally.

AI/ML Overview

The CL24N device is a 2.1MP Color LCD Monitor intended for displaying digital medical images for review by trained medical practitioners. It is not intended for displaying mammography images for diagnosis.

Here's a breakdown of the acceptance criteria and the study conducted to prove the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the tests performed to demonstrate compliance with "Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017." The reported device performance is that it met these criteria.

Test Item	Acceptance Criteria (Implied by standard)	Reported Device Performance
Pixel Defects	Meets industry standards for acceptable pixel defects in medical displays.	Met acceptance criteria.
Artifacts	Absence of artifacts that would interfere with medical image review.	Met acceptance criteria.
Luminance	Achieves specified luminance levels for medical image display (e.g., DICOM calibrated luminance, maximum luminance).	Met acceptance criteria.
Reflection	Meets industry standards for minimal reflection to ensure clear image viewing.	Met acceptance criteria.
Luminance Uniformity	Achieves uniform luminance across the display surface.	Met acceptance criteria.
Veiling Glare	Meets industry standards for minimal veiling glare to maintain image contrast.	Met acceptance criteria.
Color Uniformity	Achieves uniform color display across the screen.	Met acceptance criteria.
Luminance Response	Complies with DICOM Part 14 Grayscale Standard Display Function (GSDF) for accurate grayscale rendition.	Met acceptance criteria.
Luminance at 30° and 45° in horizontal, and vertical directions	Maintains acceptable luminance at specified viewing angles.	Met acceptance criteria.
Luminance Stability Test	Demonstrates stable luminance over time and operating conditions.	Met acceptance criteria.
Color Tracking	Accurate and consistent color reproduction.	Met acceptance criteria.
Gray Tracking	Accurate and consistent grayscale reproduction.	Met acceptance criteria.
MTF (Modulation Transfer Function)	Meets specified MTF characteristics for image sharpness and detail.	Met acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of an AI/algorithm study. The tests mentioned were performed on the CL24N device itself, not on a dataset of medical images. Therefore, the "sample size" refers to the individual device undergoing testing.

Sample Size for Test Set: Not applicable as it's a device performance test, not a data-driven algorithm test. The testing was conducted on the CL24N device.
Data Provenance: Not applicable. The testing directly evaluated the monitor's physical and display characteristics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The tests performed are objective, physics-based measurements of the monitor's display characteristics (e.g., luminance, uniformity, pixel defects). They do not require expert interpretation to establish ground truth in the way medical images would for diagnostic algorithms.

4. Adjudication Method for the Test Set

Not applicable. The tests are direct measurements against pre-defined technical specifications and industry standards. There is no need for expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No MRMC comparative effectiveness study was done. This device is a medical monitor, an output display device, and does not incorporate AI for diagnostic assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance study was done. As stated, this is a display monitor, not a diagnostic algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by the specified technical parameters and compliance with recognized industry standards (e.g., IEC 60601-1, DICOM Part 14 GSDF, and the FDA's guidance document "Display Devices for Diagnostic Radiology"). The device's characteristics are measured and compared against these objective standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical monitor, not a machine learning model. There is no training set involved.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set.

Summary

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WIDE Corporation % Josh Baker Consultant OT Consulting Inc. 33781 Bayside Lane DANA POINT CA 92629

Re: K222717

October 31, 2022

Trade/Device Name: CL24N 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 Josh 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

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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, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of 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) K222717

Device Name CL24N

Indications for Use (Describe)

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)]

06/13/2022

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
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

3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]

Model Name:	CL24N
Common Name:	2.1MP Color LCD Monitor
Classification Name:	Medical Image management and Processing System
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:	K143261
Applicant:	EIZO CORPORATION
Model Name:	RadiForce MX242W
Common Name:	2.3MP Color LCD Monitor
Classification Name:	Display, Diagnostic Radiology

510(k) Summary 1/4

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Regulation Number: 21 CFR 892.2050 Product Code: PGY Device Class: 2

5. Description of the Device [21 CFR 807.92(a) (4)]

EzCal is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.

EzCal is packed with the display.

While using the CL24N product, use the EzCal S/W provided as a bundle to periodically check whether the product meets the intended use.

If the product does not meet the intended use, the product must be returned to the manufacturer or an authorized service center to be calibrated to a product that can be used normally.

6. Intended Use [21 CFR 807.92(a) (5)]

CL24N LCD Monitor is intended to be used to display and view digital medical images for review by trained medical practitioners. It does not support the display of mammography images for diagnosis.

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	DiscussionofDifferences
Product	RadiForce MX242W	CL24N
Screentechnology	IPS TFT Color LCDPanel	AAS TFT Color LCDPanel	Provided by the panelmanufacturers.
Viewingangle (H, V)	H: 178°, V: 178°	H: 178°, V: 178°	-
Active screensize	518.4 mm x 324.0 mm	527.04 mm x 296.48 mm	Provided by the panelmanufacturers.
Resolution	2.3MP (1,920 x 1,200)	2.1MP (1920 x 1080)	Differences bymanufacturers.
Aspect ratio	16 : 10	16 : 9	Provided by the panelmanufacturers.
Pixel pitch	0.270 mm x 0.270 mm	0.2745 mm x 0.2745mm	Provided by the panelmanufacturers.
Maximumluminance	350 cd/m²	400 cd/m²	Provided by the panelmanufacturers.
DICOMcalibratedluminance	180 cd/m²	150 cd/m²	Differences bymanufacturers.
Contrast ratio	1000 : 1	1000 : 1	-
Backlighting	LED	LED
DisplayColors	From a palette of 68billion colors:- 10-bit input(DisplayPort): 1.07billion colors(maximum)- 8-bit input: 16.77million colors	From a palette of 1.07billion colors:- 8-bit input: 16.77million colors	Tone between thepredicate device andour subject devicesare different. But Itpass the exams inAAPM-TG18 4.3 "Luminance response".Therefore, they areequivalent to thepredicate device.
Luminancenon-uniformitycompensation	Digital UniformityEqualizer	-	Differences bymanufacturers.
Input videosignals	DVI-I x 1,DisplayPort x 1	Mini HDMI x 1,Mini DisplayPort x 1	It is only a differenceconnector types, butthe functions aresimilar.
ScanningFrequency(H, V)	Digital: 31 - 76 kHz / 59- 61 Hz (VGA Text: 69 -71 Hz)Frame synchronousmode: 59 - 61 HzAnalog: 26 - 76 kHz /49 - 71 Hz (VGA Text:69 - 71 Hz)Frame synchronousmode: 59 - 61 Hz	67.5KHz, 60Hz	Differences bymanufacturers.
PowerRequirements	AC 100 - 240 V,50 / 60 Hz	AC 100~240 V: 50 /60 HzDC +12V, 3A	Differences bymanufacturers.
PowerConsumption/ Save Mode	68 W / Less than 0.5 W	30 W / Less than 5 W	Differences bymanufacturers.
PowerManagement	Digital : DVI DMPM,DisplayPort 1.1aAnalog : VESA DPM	DVI DMPM,DisplayPort 1.1a	Differences bymanufacturers.
QC software	RadiCS	EzCal	It is only a differencein terms of eachmanufacturer, but thefunctions are similar.
Sensors	Backlight Sensor	IQ Sensor,Ambient Light Sensor,Human Sensor	Differences bymanufacturers
USB Ports /Standard	1 upstream,2 downstream / Rev.2.0	-	Differences bymanufacturers.
Dimensionsw/o stand(W x H x D)	575 x 398 x 71 mm	538.52 x 326.22 x 35.1mm	Different housingdesign.

8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]

510(k) Summary 2/4

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CL24N 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

CL24N comply with the following international and FDA-recognized consensus standards: ANSI/AAMI ES60601-1: 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 CL24N 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, Luminance Stability test, Color Tracking, Gray Tracking, MTF

The tests showed that the device has similar characteristics compared to the predicated device.

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 ANSI/AAMI ES 60601-1 and IEC 60601-1-2. The effectiveness of the device was validated through bench tests.

The results of these tests demonstrate that CL24N 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.

Regulation Number and Section

§ 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).