(53 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 monitor intended for displaying medical images for review by practitioners, not for directly treating a disease or condition.
No
The device is a monitor used to display medical images for review; it does not perform any diagnostic function itself.
No
The device description clearly states that the CL24N is a "Medical Monitor" and includes details about hardware performance tests (Pixel Defects, Artifacts, Luminance, etc.) performed on the monitor itself. While it includes software (EzCal), the core device is a hardware display system.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The CL24N LCD Monitor System is a display device. Its purpose is to show digital medical images for review by medical practitioners. 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." This is a display function, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, sample handling, or analysis of biological materials, which are hallmarks of IVD devices.
The device is a medical image display system, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PGY
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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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)
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.
No clinical studies were considered necessary and performed.
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
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, 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)
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.
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)]
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.
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 | Discussion
of
Differences |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | RadiForce MX242W | CL24N | |
| Screen
technology | IPS TFT Color LCD
Panel | AAS TFT Color LCD
Panel | Provided by the panel
manufacturers. |
| Viewing
angle (H, V) | H: 178°, V: 178° | H: 178°, V: 178° | - |
| Active screen
size | 518.4 mm x 324.0 mm | 527.04 mm x 296.48 mm | Provided by the panel
manufacturers. |
| Resolution | 2.3MP (1,920 x 1,200) | 2.1MP (1920 x 1080) | Differences by
manufacturers. |
| Aspect ratio | 16 : 10 | 16 : 9 | Provided by the panel
manufacturers. |
| Pixel pitch | 0.270 mm x 0.270 mm | 0.2745 mm x 0.2745
mm | Provided by the panel
manufacturers. |
| Maximum
luminance | 350 cd/m² | 400 cd/m² | Provided by the panel
manufacturers. |
| DICOM
calibrated
luminance | 180 cd/m² | 150 cd/m² | Differences by
manufacturers. |
| Contrast ratio | 1000 : 1 | 1000 : 1 | - |
| Backlighting | LED | LED | |
| Display
Colors | From a palette of 68
billion colors:
- 10-bit input
(DisplayPort): 1.07
billion colors
(maximum) - 8-bit input: 16.77
million colors | From a palette of 1.07
billion colors: - 8-bit input: 16.77
million colors | Tone between the
predicate device and
our subject devices
are different. But It
pass the exams in
AAPM-TG18 4.3 "
Luminance response".
Therefore, they are
equivalent to the
predicate device. |
| Luminance
non-uniformity
compensation | Digital Uniformity
Equalizer | - | Differences by
manufacturers. |
| Input video
signals | DVI-I x 1,
DisplayPort x 1 | Mini HDMI x 1,
Mini DisplayPort x 1 | It is only a difference
connector types, but
the functions are
similar. |
| Scanning
Frequency
(H, V) | Digital: 31 - 76 kHz / 59 - 61 Hz (VGA Text: 69 -
71 Hz)
Frame synchronous
mode: 59 - 61 Hz
Analog: 26 - 76 kHz /
49 - 71 Hz (VGA Text:
69 - 71 Hz)
Frame synchronous
mode: 59 - 61 Hz | 67.5KHz, 60Hz | Differences by
manufacturers. |
| Power
Requirements | AC 100 - 240 V,
50 / 60 Hz | AC 100~240 V: 50 /
60 Hz
DC +12V, 3A | Differences by
manufacturers. |
| Power
Consumption
/ Save Mode | 68 W / Less than 0.5 W | 30 W / Less than 5 W | Differences by
manufacturers. |
| Power
Management | Digital : DVI DMPM,
DisplayPort 1.1a
Analog : VESA DPM | DVI DMPM,
DisplayPort 1.1a | Differences by
manufacturers. |
| QC software | RadiCS | EzCal | It is only a difference
in terms of each
manufacturer, but the
functions are similar. |
| Sensors | Backlight Sensor | IQ Sensor,
Ambient Light Sensor,
Human Sensor | Differences by
manufacturers |
| USB Ports /
Standard | 1 upstream,
2 downstream / Rev.
2.0 | - | Differences by
manufacturers. |
| Dimensions
w/o stand
(W x H x D) | 575 x 398 x 71 mm | 538.52 x 326.22 x 35.1
mm | Different housing
design. |
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
510(k) Summary 2/4
5
6
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.