(70 days)
Not Found
No
The summary describes a medical display monitor and associated quality control software. There is no mention of AI or ML capabilities, and the performance studies focus on display characteristics and conformance to standards, not algorithmic performance.
No
The device is a medical display monitor used for viewing digital images, not for treating or diagnosing medical conditions. It serves as an accessory for medical imaging systems.
No
The device is a monitor intended for "displaying and viewing digital images by trained medical practitioners" and explicitly states it "does not support the display of mammography images for diagnosis." It functions as an accessory for diagnostic monitors, as indicated by the mention of "RadiCS... offering worry-free quality control of the diagnostic monitors including GX240." This suggests it is a display tool rather than a device performing diagnostic analysis.
No
The device description explicitly states it is a monochrome LCD monitor, which is a hardware component. While it includes software (RadiCS), the primary device is hardware.
Based on the provided information, the RadiForce GX240 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "displaying and viewing digital images by trained medical practitioners." This describes a device used for presenting visual information, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description focuses on the technical specifications of a monitor designed for viewing medical images. It mentions features related to image display quality and calibration, not laboratory testing or analysis of biological materials.
- Lack of IVD Characteristics: The description does not mention any components, processes, or intended uses typically associated with IVD devices, such as reagents, assays, sample handling, or analysis of biological fluids or tissues.
- Performance Studies: The performance studies described are focused on the display characteristics and image quality of the monitor, not on the accuracy or reliability of diagnostic tests performed on biological samples.
In summary, the RadiForce GX240 is a medical image display device, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The RadiForce GX240 is intended to be used in displaying and viewing digital images by trained medical practitioners. The RadiForce GX240 does not support the display of mammography images for diagnosis.
Product codes
LLZ
Device Description
The RadiForce GX240 is a monochrome LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 1,200 x 1,600 pixels (2MP) with a pixel pitch of 0.270 mm.
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 "GX240" such as "GX240-CL", a model whose backlight is Clear Base (one of tints) although the hardware design, components and labeling remain unchanged.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including GX240 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 GX240.
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.
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 bench tests were performed on the RadiForce GX240:
- Verification of the conformance to DICOM GSDF as specified in Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)
- Measurement of the luminance non-uniformity characteristics of the display screen as specified in the TG18 guideline
- Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in the TG18 guideline
- Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance as specified in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions
- Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in the TG18 guideline
- The maximum number allowed for each type of pixel defects/faults agreed with the manufacturer from which Eizo buys the LCD panels for RadiForce GX240
The test results showed that the RadiForce GX240 has display performances substantially equivalence to those of the predicate device. RadiForce GS220. Besides, the display performances of the RadiForce GX240 meet the pre-defined criteria are set.
No animal or clinical testing was performed on the RadiForce GX240.
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).
0
K120407
APR 1 9 2012
Image /page/0/Picture/1 description: The image shows the logo for EIZO. The logo consists of a square shape with a checkered pattern on the left side and the word "EIZO" in bold letters on the right side. There is a registered trademark symbol next to the letter "O" in "EIZO".
EIZO NANAO CORPORATION, 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Japan
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 System Standards Telephone Fax
Date
+81 (76) 274-2468 +81 (76) 274-2484
February 6th, 2012
Traditional 510(k) Summary (in accordance with 21 CFR 807.92)
-
- Date of Summary February 6th, 2012
-
- Company EIZO NANAO CORPORATION 153 Shimokashiwano, Hakusan Ishikawa 924-8566 Japan
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- Authorized Contact Person Hiroaki Hashimoto
4. Device Information
- Trade Name/Model: RadiForce GX240 .
- Common Name: 2MP Monochrome LCD Monitor .
- . Classification Name: System, Image Processing, Radiological
- Regulation Number: 21 CFR 892.2050, Product Code LLZ .
5. Predicate Device
- Monochrome LCD Monitor, RadiForce GS220 (K070131) .
6. Device Description
The RadiForce GX240 is a monochrome LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 1,200 x 1,600 pixels (2MP) with a pixel pitch of 0.270 mm.
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.
U.S. Food and Drug Administration
Center for Devices and Radiological H
Section 05
ce
1
Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "GX240" such as "GX240-CL", a model whose backlight is Clear Base (one of tints) although the hardware design, components and labeling remain unchanged.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including GX240 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 GX240.
7. Intended Use
The RadiForce GX240 is intended to be used in displaying and viewing digital images by trained medical practitioners. The RadiForce GX240 does not support the display of mammography images for diagnosis.
8. Technological Characteristics
The RadiForce GX240 can be said to have at least the same display performances as those of the predicate device, RadiForce GS220 by default due to the following reasons:
- a. The matrix sizes (1,200 x 1,600) and the active area sizes (324.0 mm x 432.0 mm) of the LCD panels used by the both devices are the same.
- b. The DICOM calibrated luminance values of the both devices are the same (500 cd/m') though the typical maximum luminance values (1,200 cd/m2) is higher than that of the predicate device (1,000 cd/m). The higher luminance to be maintained constantly was realized by the employment of LED backlight deteriorating more slowly than conventional CCFL backlights.
- c. 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.
- d. The both devices display images in accordance with DICOM GSDF by default utilizing the factory calibrated display mode stored in lookup tables inside of them.
- e. As for input video signal, in addition to the Digital Visual Interface (DVI) also supported by the predicate device, RadiForce GX240 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.
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, GX240 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
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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".
9. Performance Testing
The following bench tests were performed on the RadiForce GX240:
- Verification of the conformance to DICOM GSDF as specified in Assessment of Display . Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)
- . Measurement of the luminance non-uniformity characteristics of the display screen as specified in the TG18 guideline
- Measurement of the chromaticity non-uniformity characteristics of the display screen as . specified in the TG18 guideline
- Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% . of the maximum luminance as specified in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions
- . Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in the TG18 guideline
- . The maximum number allowed for each type of pixel defects/faults agreed with the manufacturer from which Eizo buys the LCD panels for RadiForce GX240
The test results showed that the RadiForce GX240 has display performances substantially equivalence to those of the predicate device. RadiForce GS220. Besides, the display performances of the RadiForce GX240 meet the pre-defined criteria are set.
No animal or clinical testing was performed on the RadiForce GX240.
10. Conclusion
The 2MP Monochrome LCD Monitor, RadiForce GX240 is substantially equivalent to the predicate device with respect to technical characteristics, performance, application and intended use. The specifications of the primary component employed by the proposed device are the same as 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, represented by three curved lines.
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 Regulatory Affairs Manager EIZO NANAO Corporation 153 Shimokashiwano 924-8566 HAKUSAN ISHIKAWA JAPAN
APR 1 9 2012
Re: K120407
Trade/Device Name: 2MP Monochrome LCD Monitor, RadiForce GX240 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 6, 2012 Received: February 9, 2012
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 (reporting of
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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,
Janine M. Morris
Acting 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):
2MP Monochrome LCD Monitor, RadiForce GX240 . Device Name:
Indications for Use:
The RadiForce GX240 is intended to be used in displaying and viewing digital images by trained medical practitioners. The RadiForce GX240 does not support the display of mammography images for diagnosis.
X Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (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)
Michael D. Thomas
Division Sian-Of Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KIA0407
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