(90 days)
Not Found
No
The summary describes a medical display monitor with features for image quality and stability, but there is no mention of AI or ML being used for image processing, analysis, or any other function. The performance studies focus on display characteristics, not algorithmic performance.
No.
The device is a display monitor intended for viewing medical images for diagnosis, not for providing therapy.
No.
This device is a medical display monitor for viewing images, not a diagnostic device itself. Its intended use is to display images for diagnosis, and it undergoes performance tests related to image display characteristics.
No
The device description explicitly states it is a "32-inch 8MP Color LCD Monitor CL-R813" and details hardware components like the LCD panel, luminance sensor, and control circuit. The performance studies also focus on hardware characteristics of the display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "displaying and viewing medical images for diagnosis." This describes a device used to present visual information to a medical professional, not a device that performs a test on a biological sample to provide diagnostic information.
- Device Description: The description focuses on the technical specifications of a monitor designed for displaying medical images (color LCD panel, luminance stabilization, DICOM GSDF conformance, mura correction). These are characteristics of a display device, not an IVD.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring analytes.
- Providing a result based on a test performed on a sample.
- Reagents or test kits.
The device is clearly a medical image display monitor, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
CL-R813 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel.
It is not meant to be used in digital mammography.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
32-inch 8MP Color LCD Monitor CL-R813, 3840 x 2160 (landscape)
- Color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
- Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
- Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
- Luminance mura correction functions will help achieve uniformity on the whole screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners or certified personnel.
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 following performance tests were performed on the CL-R813 in accordance with the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on October 2, 2017.
- a. Spatial resolution: The bar pattern is displayed and captured by a digital camera equipped with a macro lens. The MTF is calculated with the captured data.
- b. Pixel defects (maximum counts, allowed defect types, and locations): ISO 13406-2; IDMS 1.03, 7.6 DEFECTIVE PIXELS; Pixel defects are counted based on the ISO13406-2, 3.4.13 table 3.
- c. Artifacts: AAPM-TG18, 4.9 Miscellaneous Tests; IDMS 1.03, 4.6 ARTIFACTS & IRREGULARITIES
- d. Temporal response: IDMS 1.03, 10.2.3 GRAY-TO-GRAY RESPONSE TIME; Rise and fall time constants at four grayscale intervals (0-100%, 5-95%, 10-90%, 40-60%) are provided by the panel manufacturer.
- e. Luminance (maximum, minimum, achievable, and recommended): Lmin and Lmax on the calibrated luminance are confirmed.
- f. Conformance to a grayscale to luminance function (e.g., DICOM GSDF): AAPM-TG18, 4.3.5 Advanced Luminance Response; Luminance response for 256 levels are measured.
- (For color displays) m. Color tracking (primary colors and color gamut): Color scale: IDMS 1.03, 6. Gray- and Color-Scale Measurement; IDMS 1.03, 5.4 Color-Signal White; Color gamut volume: IDMS 1.03, 5.31 Volume-Color-Reproduction Capability
- (For color displays) n. Gray tracking (gray shades and white point): AAPM-TG196 Gray Tracking; IEC 62563-1: 2009+AMD1:2016+AMD2:2021, 7.4.9 Greyscale chromaticity evaluation
As a result of the performance test, it was confirmed that the CL-R813 has the equivalent display characteristics as the predicate device, CL-R211. The display characteristics of the CL-R813 meet the predefined criteria.
The CL-R813 has not been tested on animal or clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
0
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" stacked on top of the word "ADMINISTRATION".
JVCKENWOOD Corporation Hideki Tengeiji Senior Manager 3-12, Moriya-cho, Kanagawa-ku Yokohama, Kanagawa 221-0022 Japan
December 21, 2022
Re: K222864
Trade/Device Name: 8MP Color LCD Monitor CL-R813 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: December 14, 2022 Received: December 15, 2022
Dear Hideki Tengeiji:
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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 Low
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222864
Device Name 8MP Color LCD Monitor CL-R813
Indications for Use (Describe)
CL-R813 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel.
It is not meant to be used in digital 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) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K222864
510(k) SUMMARY
I. Submitter
| Submitter: | JVCKENWOOD Corporation |
|---|---|
| 3-12, Moriya-cho, Kanagawa-ku, | |
| Yokohama-shi, Kanagawa, 221-0022 Japan | |
| Contact Person: | Hideki Tengeiji, Senior Manager |
| Email: tengeiji.hideki@jvckenwood.com | |
| Tel: +81-45-450-2715 | |
| Fax: +81-45-450-1926 | |
| Date Prepared: | September 22, 2022 |
II. Device
| Name of Device: | 8MP Color LCD Monitor CL-R813 |
|---|---|
| Common or Usual Name: | Display, diagnostic radiology |
| Classification Name: | Medical Image Management and Processing System |
| (Part 892 Radiology Devices Sec. 892.2050) | |
| Regulatory Class | II |
| Product Code | PGY |
III. Predicate Device
| Name of Device: | 21.3 inch (54.0cm) Color LCD Monitor CL-R211 (K182539) |
|---|---|
| Common or Usual Name: | Display, diagnostic radiology |
| Classification Name: | Medical Image Management and Processing System |
| (Part 892 Radiology Devices Sec. 892.2050) | |
| Regulatory Class | II |
| Product Code | PGY |
JVCKENWOOD
4
IV. Device Description
32-inch 8MP Color LCD Monitor CL-R813, 3840 x 2160 (landscape)
- Color LCD panel, which has wide view angle, is used for this product. It is designed for ■ medical image display.
- Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
- Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
- Luminance mura correction functions will help achieve uniformity on the whole screen.
V. Indications for use
CL-R813 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
VI. Cybersecurity
FDA quidance located at https://www.fda.gov/media/86174/download, is followed for cybersecurity concerns.
5
VII. Comparison of Technological Characteristics with the predicate device
The comparison table below list information obtained from the product catalogs and measurements and different technological characteristics are discussed in it.
| | Predicate device
LCD Monitor CL-R211 | Proposed device
LCD Monitor CL-R813 | Explanation of
Differences |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K182539 | - | - |
| Indication for use | CL-R211 is intended to be
used in displaying and viewing
medical images for diagnosis
by trained medical
practitioners or certified
personnel. It is not meant to
be used in digital
mammography. | CL-R813 is intended to be
used in displaying and
viewing medical images for
diagnosis by trained medical
practitioners or certified
personnel. It is not meant to
be used in digital
mammography. | - |
| Display Technology | IPS LCD panel with TFT
active-matrix array with LED
backlight | IPS LCD panel with TFT
active-matrix array with LED
backlight | - |
| Screen size | Diagonal: 21.3"
Aspect ratio: 4:3 | Diagonal: 32"
Aspect ratio: 16:9 | The display area of the
proposed device is larger
than that of the predicate
device. |
| Backlight type | LED | LED | - |
| Frame rate and refresh rate | 60Hz | 60Hz | - |
| Resolution / Pixel array | 2MP (1200 x 1600) | 8MP (3840 × 2160) | The resolution of the
proposed device is higher
than that of the predicate
device. |
| Pixel Pitch | Horizontal: 0.270mm
Vertical: 0.270mm | Horizontal: 0.1845mm
Vertical: 0.1845mm | Pixel pitch of the
proposed device are
smaller than those of the
predicate device. |
| Subpixel pattern | Stripe RGB | Stripe RGB | - |
| Pixel aperture ratio | 57 % | 57 % | - |
| Subpixel driving (spatial and
temporal dithering) | N/A | N/A | - |
| Display Interface | Input: DVI-D x1
DisplayPort x1
Output: DisplayPort x1 | Input: DVI-D x1
DisplayPort x2
Output: DisplayPort x1 | - |
| Video bandwidth | Dot clock: 162 MHz | Dot clock: 533.25 MHz | So the resolution of the
proposed device is higher
than that of the predicate
device, the dot clock of
the proposed device is
higher than that of the
predicate device |
| User control | DICOM CONFORMANCE TEST
Configuration switch
Input signal switch
Dynamic gamma
AUTO TEXT
Human presence sensor
EDID switch
Test pattern
USB Power | Config Select
Backlight
Contrast
Source Select
Human Sensor | Although the user
controls are different, the
performance of the
proposed device is the
same as the predicate
device. |
| Ambient light sensing | Built-in Sensor (For correction
during calibration) | Built-in Sensor (For
correction during calibration) | - |
| Touch-screen technology | N/A | N/A | - |
| Luminance calibration tools /
Quality-control procedures | Hardware:
Integrated sensor
External sensor
Software:
QA Medivisor/Medivisor NX
FCAL | Hardware:
Integrated sensor
External sensor
Software:
QA Medivisor Agent
FCAL | - |
| Additional Software/Firmware | N/A | N/A | - |
The above differences in technical characteristics do not affect the safety and the effectiveness of the CL-R813.
JVCKE OD
6
VIII. Performance Test
The following performance tests were performed on the CL-R813 in accordance with the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on October 2, 2017.
| Performance test items
| in the guidance | Test method(s) |
|---|---|
| a. Spatial resolution | The bar pattern is displayed and captured by a digital |
| camera equipped with a macro lens. The MTF is calculated | |
| with the captured data. | |
| b. Pixel defects (maximum | |
| counts, allowed defect | |
| types, and locations) | ISO 13406-2 |
| IDMS 1.03, 7.6 DEFECTIVE PIXELS | |
| Pixel defects are counted based on the ISO13406-2, 3.4.13 | |
| table 3. | |
| c. Artifacts | AAPM-TG18, 4.9 Miscellaneous Tests |
| IDMS 1.03, 4.6 ARTIFACTS & IRREGULARITIES | |
| d. Temporal response | IDMS 1.03, 10.2.3 GRAY-TO-GRAY RESPONSE TIME |
| Rise and fall time constants at four grayscale intervals (0- | |
| 100%, 5-95%, 10-90%, 40-60%) are provided by the | |
| panel manufacturer. | |
| e. Luminance (maximum, | |
| minimum, achievable, and | |
| recommended | Lmin and Lmax on the calibrated luminance are confirmed. |
| f. Conformance to a grayscale | |
| to luminance function (e.g., | |
| DICOM GSDF) | AAPM-TG18, 4.3.5 Advanced Luminance Response |
| Luminance response for 256 levels are measured. | |
| (For color displays) | |
| m. Color tracking (primary | |
| colors and color gamut) | Color scale: |
| IDMS 1.03, 6. Gray- and Color-Scale Measurement | |
| IDMS 1.03, 5.4 Color-Signal White | |
| Color gamut volume: | |
| IDMS 1.03, 5.31 Volume-Color-Reproduction Capability | |
| (For color displays) | |
| n. Gray tracking (gray shades | |
| and white point) | AAPM-TG196 Gray Tracking |
| IEC 62563-1: 2009+AMD1:2016+AMD2:2021, 7.4.9 | |
| Greyscale chromaticity evaluation |
As a result of the performance test, it was confirmed that the CL-R813 has the equivalent display characteristics as the predicate device, CL-R211. The display characteristics of the CL-R813 meet the predefined criteria.
The CL-R813 has not been tested on animal or clinical testing.
IX. Conclusions
As shown above, the intended use of the subject device and the predicate device is identical, the technical characteristics are similar, and any differences in the characteristics do not affect the safety or effectiveness of the device. The results of the performance testing and the verification and validation demonstrate that the subject device is substantially equivalent to the predicate device currently on the market.