(71 days)
Not Found
No
The description focuses on the monitor's display characteristics, calibration, and quality control software, with no mention of AI or ML for image analysis or processing.
No
The device is a medical monitor used for displaying and viewing digital medical images for diagnosis, not for treating any condition or disease.
No
Explanation: This device is a monitor used for displaying medical images for diagnosis, not a diagnostic device itself. It's a display tool that supports diagnosis, but doesn't perform the diagnosis or image processing.
No
The device description clearly states it is a "monochrome LCD monitor" and describes hardware characteristics like matrix size and pixel pitch. While it includes accessory software (RadiCS), the primary device being submitted is a physical monitor.
Based on the provided text, the RadiForce GX340 is not an IVD (In Vitro Diagnostic) device.
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 visualize medical images, not a device used to examine specimens from the human body (which is the core function of an IVD).
- Device Description: The description focuses on the technical specifications of a monitor (LCD, resolution, pixel pitch, tone curves, luminance, color temperature). This aligns with a display device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information about a patient's health status based on sample analysis
The device is clearly described as a medical image display monitor used by trained medical practitioners for diagnostic purposes based on imaging modalities like X-ray and MRI. This falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The RadiForce GX340 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 is not specified for digital mammography system.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The RadiForce GX340 is a monochrome LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.2115 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 "GX340" such as "GX340-CL", a model whose backlight is Clear Base (one of tints) .
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including GX340 based on several OC guidelines. The RadiCS and its subset. RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce GX340.
Mentions image processing
System, Image Processing, Radiological Classification Name: .
Mentions AI, DNN, or ML
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The overall design of the RadiForce GX340 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 GX340 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): 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.
Monochrome LCD Monitor, RadiForce GS320 (K062053)
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/1 description: The image shows the logo for EIZO. The logo consists of a stylized, geometric shape on the left and the word "EIZO" in bold, sans-serif font on the right. The geometric shape is composed of small squares or pixels, arranged in a way that suggests a three-dimensional object. A registered trademark symbol is located to the right of the word "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 Department
Fax
Date
Hiroaki Hashimoto Medical System Standards
Telephone +81 (76) 274-2468 +81 (76) 274-2484 hiro@nanao.co.jp
December 19th, 2011
Traditional 510(k) Summary (in accordance with 21 CFR 807.92)
-
- Date of Summary December 19th, 2011
-
- Company EIZO NANAO CORPORATION 153 Shimokashiwano, Hakusan Ishikawa 924-8566 Japan
-
- Authorized Contact Person Hiroaki Hashimoto
4. Device Information
- Trade Name/Model: RadiForce GX340 ●
- Common Name: 3MP Monochrome LCD Monitor ●
- System, Image Processing, Radiological Classification Name: .
- 21 CFR 892,2050, Product Code LLZ Classification Number: ●
5. Predicate Device
- Monochrome LCD Monitor, RadiForce GS320 (K062053) ●
6. Device Description
The RadiForce GX340 is a monochrome LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.2115 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.
Section 05
Traditional 510(k) Summary_GX340: Page 1 of 3
1
Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "GX340" such as "GX340-CL", a model whose backlight is Clear Base (one of tints) .
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including GX340 based on several OC guidelines. The RadiCS and its subset. RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce GX340.
7. Intended Use
The RadiForce GX340 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 is not specified for digital mammography system.
8. Technological Characteristics
The RadiForce GX340 can be said to have at least the same display performances as those of the predicate device by default due to the following reasons:
- The matrix sizes (1536 x 2048) and the active area sizes (324.8 mm x 433.1 mm) of a. the LCD panels used by the both devices are the same.
- The DICOM calibrated luminance (500 cd/m2) and the typical maximum luminance ﻓ (1200 cd/m2) are higher than those of the predicate device (450 cd/m2, 1000 cd/m2). The higher luminance to be maintained constantly was realized by the employment of LED backlight deteriorating more slowly than conventional CCFL backlights.
- The LED backlight was newly employed instead of CCFL backlight because it is c. 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 d. 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 e. supported by the predicate device, RadiForce GX340 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, GX340 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
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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 GX340 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 GX340 performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.
9. Conclusion
The 3MP Monochrome LCD Monitor, RadiForce GX340 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 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 Department of Health & Human Services. The logo includes the department's seal on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The seal features a stylized human figure and a circular border with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
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 HAKUSAN ISHIKAWA 924-8566 JAPAN
4 2012 MAY
Re: K113784
Trade/Device Name: 3MP Monochrome LCD Monitor, RadiForce GX340 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 19, 2011 Received: December 22, 2011
Dear Mr. Hashimoto:
This letter corrects our substantially equivalent letter of March 2, 2012.
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): _ K13787
3MP Monochrome LCD Monitor, RadiForce GX340 Device Name:
Indications for Use:
The RadiForce GX340 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 is not specified for digital mammography system.
X Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Postil
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113784
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