(46 days)
Not Found
No
The description focuses on the monitor's display capabilities, resolution, calibration, and associated quality control software. There is no mention of AI or ML being used for image analysis, processing, or any other function within the device or its accessories.
No.
The device is a monitor used for displaying medical images for diagnosis, not for treating or preventing a disease or condition.
No
Explanation: The device is a monitor used for viewing images for diagnosis, but it does not perform the diagnosis itself. Its intended use is to display images for viewing by medical practitioners, and it is described as a "color LCD monitor for viewing medical images."
No
The device description clearly states that the RadiForce RX840 is a "color LCD monitor," which is a hardware component. While it includes software (RadiCS), the primary device being submitted is a physical monitor.
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 digital images for diagnosis of X-ray or MRI, etc." This describes a device used to present medical images to a trained medical practitioner for interpretation.
- Device Description: The device is described as a "color LCD monitor for viewing medical images." This is a display device, not a device that performs tests on biological samples.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with biological samples in this way.
The device is a medical image display monitor, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The RadiForce RX840 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
Product codes
LLZ
Device Description
The RadiForce RX840 is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 4096 x 2160 pixels (8MP), spacious enough to display e.g. two 3MP radiological images and other clinical information side by side without obtrusive bezels.
Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used.
Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "RX840" such as "RX840-AR", a model with an Anti-Reflective coating.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including RX840 based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce RX840.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray or MRI, etc.
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 overall design of the RadiForce RX840 was validated in accordance with internationally recognized safety and EMC standards by independent testing facilities and in-house ones. Besides, EIZO NANAO CORPORATION performed a range of system and performance tests to ensure that the RadiForce RX840 performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 shows the logo for EIZO. The logo consists of a stylized square shape with a checkered pattern in the upper right corner. The word "EIZO" is written in bold letters below the square.
DEC 1 7 2011
EIZO NANAO CORPORATION, 153 Shimokashiwano, Hakusan, Ishikawa
U.S. Food and Drug Administration Center for Devices and Radiological Health Document Mail Center - WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
| Name | Hiroaki Hashimoto |
|---|---|
| Department | Medical Device Standards |
| Telephone | +81 (76) 274-2468 |
| Fax | +81 (76) 274-2484 |
| hiro@nanao.co.jp | |
| Date | October 28th, 2011 |
Traditional 510(k) Summary (in accordance with 21 CFR 807.92)
-
- Date of Summary
October 28th, 2011
- Date of Summary
-
- Company EIZO NANAO CORPORATION 153 Shimokashiwano, Hakusan Ishikawa 924-8566 Japan
-
- Authorized Contact Person Hiroaki Hashimoto
4. Device Information
- Trade Name/Model: . RadiForce RX840
- Common Name: . 8MP Color LCD Monitor
- Classification Name: . System, Image Processing, Radiological
- . Classification Number: 21 CFR 892.2050, Product Code LLZ
5. Predicate Device
- Color LCD Monitor, FlexScan MX300W (K073340) .
6. Device Description
The RadiForce RX840 is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 4096 x 2160 pixels (8MP), spacious enough to display e.g. two 3MP radiological images and other clinical information side by side without obtrusive bezels.
Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used.
1
Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "RX840" such as "RX840-AR", a model with an Anti-Reflective coating.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including RX840 based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce RX840.
7. Intended Use
The RadiForce RX840 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
8. Technological Characteristics
The RadiForce RX840 can be said to have at least the same display performances as those of the predicate device by default due to the following reasons:
- Both the matrix size and the active area size of the LCD panel used (4,096 x 2,160, a. 817.1 mm x 430.9 mm) are larger than those of the predicate device (2,560 x 1,600, 641.3 mm x 400.8 mm).
- The smaller pixel pitch or pixel size (0.1995 x 0.1995 mm) than that of the predicate b. device (0.2505 x 0.2505 mm) means higher density usually resulting in higher quality of displayed images. If one cares about the smaller pixel size, the perceived pixel size similar to that of the predicate device can be realized easily by adjusting the viewing distance.
- The DICOM calibrated luminance (400 cd/m²) and the typical maximum luminance C. (700 cd/m2) is higher than that of the predicate device (170 cd/m², 300 cd/m²). The higher luminance to be maintained constantly was realized by the employment of LED backlight deteriorating more slowly than conventional CCFL backlights.
- d. The LED backlight was newly employed instead of CCFL backlight because it is mercury-free, consumes less power and deteriorates more slowly. We have not recognized any adverse effects of the LED backlight on the quality of displayed images. Refer to section 18 "Performance Testing - Bench" where several image quality characteristics of the proposed device are compared with those of the predicate device.
- The both devices display images in accordance with DICOM GSDF by default e. utilizing the factory calibrated display mode stored in lookup tables inside of them.
- As for input video signal, in addition to the Digital Visual Interface (DVI) also f. supported by the predicate device, RadiForce RX840 supports DisplayPort, another type of digital video interface based on an industrial standard. As far as the both the DVI and the DisplayPort are digital, their differences do not affect the quality of displayed images.
. + =
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As for the maintenance, the same QC software is used for the both devices and the implementation of the Backlight Sensor (BS) stabilizing the backlight is also the same.
As for built-in sensors, in addition to BS common to the both devices, RX840 has three kinds of sensors. However, only the Built-in Front Sensor (IFS) has something to do with the maintenance or the calibration; the Presence Sensor (PS) detects the absence of the user to trigger the power saving mode of the monitor and the Ambient Light Sensor (ALS) is used to measure the ambient light by lx. The IFS enables automatic grayscale calibration by measuring the luminance at the screen surface. Without IFS, the grayscale calibration process requires human intervention and the use of an external sensor. The accuracy data of the calibration with external sensors and that with the IFS is included in section 16.9 "Verification and Validation Documentation".
The overall design of the RadiForce RX840 was validated in accordance with internationally recognized safety and EMC standards by independent testing facilities and in-house ones. Besides, EIZO NANAO CORPORATION performed a range of system and performance tests to ensure that the RadiForce RX840 performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.
9. Conclusion
The 8MP color LCD monitor, RadiForce RX840 is substantially equivalent to the predicate device with respect to technical characteristics, application and intended use. The specifications of the primary component employed by the proposed device are superior to those of the predicate device and other differences have been independently validated. Any differences between the devices do not affect safety or effectiveness.
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Image /page/3/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread, with three lines representing the eagle's body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Hiroaki Hashimoto Manager EIZO NANAO Corporation 153 Shimokashiwano 924-8566 HAKUSAN ISHIKAWA JAPAN
DEC 1 7 2011
Re: K113226
Trade/Device Name: 8MP Color LCD Monitor, RadiForce RX840 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 31, 2011 Received: November 1, 2011
Dear Mr. Hashimoto:
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. 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number (if known): _K (ﺻﺎﺩ 3222
8MP Color LCD Monitor, RadiForce RX840 Device Name:
Indications for Use:
The RadiForce RX840 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mictael D. Kher
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113224
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