(106 days)
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No
The 510(k) summary describes a medical display monitor and associated quality control software. There is no mention of AI or ML capabilities for image analysis, interpretation, or any other function. The focus is on display technology and quality control.
No
A therapeutic device is one that treats or alleviates a disease. This device is a display monitor used for viewing and analyzing medical images, not for treatment.
No
The device is a monitor intended for displaying digital images for review and analysis by medical practitioners. It does not perform any diagnostic function itself but rather presents data for human analysis.
No
The device description clearly states it is a "5MP monochrome LCD monitor" and describes hardware components like the panel, resolution, and pixel pitch. While it includes software (RadiCS), the primary device is a physical monitor.
Based on the provided information, the RadiForce GX530 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "displaying digital images including those of digital mammography for review and analysis by trained medical practitioners." This describes a device used for viewing and interpreting medical images, which is a function of medical imaging systems, not IVD devices.
- Device Description: The description focuses on the technical specifications of a monitor designed for displaying medical images. It mentions features related to image quality, calibration, and quality control software for the monitor. This aligns with a medical display device.
- Mentions image processing: While it mentions "Image Processing," this is in the context of a radiological system, not the processing of biological samples or data derived from them, which is characteristic of IVD devices.
- Input Imaging Modality: The input is "digital images," not biological samples or data from biological tests.
- No mention of biological samples or testing: There is no mention of analyzing blood, tissue, urine, or any other biological material, which is the core function of IVD devices.
- No mention of diagnosing conditions based on biological data: The device is used for reviewing and analyzing images, not for performing tests on biological samples to diagnose conditions.
In summary, the RadiForce GX530 is a medical display device used for viewing and interpreting medical images, not a device used for testing biological samples to diagnose diseases or conditions.
N/A
Intended Use / Indications for Use
The RadiForce GX530 is intended to be used in displaying digital images including those of digital mammography for review and analysis by trained medical practitioners.
Product codes
LLZ
Device Description
The RadiForce GX530 is a 5MP monochrome LCD monitor for viewing medical images including those of digital mammography. The monochrome panel employs in-plane switching (IPS) technology allowing wide viewing angles. The matrix size (or resolution) of the panel is 2560 x 2048 pixel pitch is 0.165 mm, both of which are the same as those of displays approved so far for digital mammography including the predicate device, RadiForce GS10. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF) and a specific luminance range, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including GX530 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 GX530.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained medical practitioners
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The overall design of the RadiForce GX530 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 GX530 performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 a logo with a stylized graphic above the word "EIZO". The graphic appears to be a square shape with a checkered pattern in the upper right corner and a textured or fringed edge on the left and bottom sides. The word "EIZO" is in a bold, sans-serif font, with a small circle or dot to the right of the letter "O".
NOV 3 0 2011
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 Device Standards |
| Telephone | +81 (76) 274-2468 |
| Fax | +81 (76) 274-2484 |
| hiro@nanao.co.jp | |
| Date | August 11th, 2011 |
Traditional 510(k) Summary (in accordance with 21 CFR 807.92)
- Date of Summary 1. August 11th, 2011
-
- Company EIZO NANAO CORPORATION 153 Shimokashiwano. Hakusan Ishikawa 924-8566 Japan
-
- Authorized Contact Person Hiroaki Hashimoto
4. Device Information
- . Trade Name/Model: RadiForce GX530 5MP Monochrome LCD Monitor . Common Name: Classification Name: · System, Image Processing, Radiological .
- 21 CFR 892.2050, Product Code LLZ Classification Number: .
5. Predicate Device
5MP Monochrome LCD Monitor, RadiForce GS510 (K062054)
6. Device Description
The RadiForce GX530 is a 5MP monochrome LCD monitor for viewing medical images including those of digital mammography. The monochrome panel employs in-plane switching (IPS) technology allowing wide viewing angles. The matrix size (or resolution) of the panel is 2560 x 2048 pixel pitch is 0.165 mm, both of which are the same as those of displays approved so far for digital mammography including the predicate device, RadiForce GS10. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF) and a specific luminance range, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including GX530 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 GX530.
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Image /page/1/Picture/0 description: The image is a logo for EIZO. The logo features a stylized square made up of smaller squares in a checkerboard pattern. The word "EIZO" is written in bold, sans-serif letters below the square. The logo is black and white.
7. Intended Use
The RadiForce GX530 is intended to be used in displaying digital images including those of digital mammography for review and analysis by trained medical practitioners.
8. Technological Characteristics
RadiForce GX530 can be said to have at least the same display performance as those of the predicate device by default due to the following reasons:
- · The matrix sizes (2048 x 2560) and the active area sizes (337.9 mm x 422.4 mm) of the LCD panels used by . the both devices are the same though they are from different manufacturers.
- The both devices display images in accordance with DICOM GSDF by default utilizing the factory calibrated . display mode stored in one of the lookup tables inside of them.
- . As for input video signal, in addition to the Digital Visual Interface (DVI) also supported by the predicate device, RadiForce GX530 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 image quality.
As for the maintenance, the same OC 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, GX530 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 detects the absence of the user to trigger the power saving mode of the Ambient Light Sensor is used to measure the ambient light by Ix. The IFS enables automatic grayscale callbration 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 precision data of the callbration with an external sensor and with the IFS is provided as one of the validation data.
The overall design of the RadiForce GX530 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 GX530 performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.
9. Conclusion
Section-05
5MP Monochrome LCD Monitor, RadiForce GX530 is substantially equivalent to the predicate device with respect to technical characteristics, application and intended use. The primary components are the same and those that are different have been independently validated. Any differences between the devices do not affect safety or effectiveness.
The 510(k) Premarket Notification for the RadiForce GX530 contains sufficient information and data to enable FDA -CDRH to determine substantial equivalence to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
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
NOV 3 0 2011
Re: K112354
Trade/Device Name: 5 MP Monochrome LCD Monitor, RadiForce GX530 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 11, 2011 Received: August 16, 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, Jrug, 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,
Mary Patel
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
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Image /page/4/Picture/0 description: The image is a logo for EIZO. The logo consists of a stylized square made up of smaller squares in a checkerboard pattern. The word "EIZO" is written in bold, sans-serif letters below the square.
Indications for Use
510(k) Number (if known):
Device Name:
5 MP Monochrome LCD Monitor, RadiForce GX530
Indications For Use:
The RadiForce GX530 is intended to be used in displaying digital images including those of digital mammography for review and analysis by trained medical practitioners.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
Office of in Vitro Ding
510K
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