(62 days)
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No
The document describes a medical display monitor and associated quality control software, with no mention of AI or ML capabilities for image analysis or processing.
No
The device is a monitor used for displaying and viewing medical images, not for actively treating or diagnosing a condition.
Yes
The device is a monitor intended for displaying and viewing digital images like X-ray or MRI for trained medical practitioners, and the text mentions "diagnostic monitors" when referring to the RX430, indicating its use in diagnostic processes.
No
The device description clearly states it is a "4MP Color LCD monitor" and describes its physical characteristics (matrix size, pixel pitch). While it includes software (RadiCS), the primary device is a hardware monitor.
Based on the provided information, the RadiForce RX430 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "displaying and viewing digital images of X-ray or MRI etc." This describes a device used to present medical images to a user, not a device that performs tests on biological samples or provides diagnostic information based on such tests.
- Device Description: The description focuses on the technical specifications of a monitor (LCD panel, resolution, pixel pitch, tone curves, luminance, color temperature) and associated quality control software (RadiCS). This aligns with a display device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic results based on in vitro testing.
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. The RadiForce RX430's function is to display images generated by other medical devices (like X-ray or MRI machines).
N/A
Intended Use / Indications for Use
The RadiForce RX430 is intended to be used in displaying and viewing digital images of X-ray or MRI etc. by trained medical practitioners. The RadiForce RX430 does not support the display of mammography images for diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The RadiForce RX430 is a 4MP Color LCD monitor for viewing medical images. The matrix size of the color panel, 2560 x 1600 pixels with a pixel pitch of 0.2505 mm corresponds to two 2MP monitors in portrait mode (1200 x 1600 x 2 with a pixel pitch of e.g. 0.270 mm) and provides dual-head configuration without the obtrusive bezel in the center. 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.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including RX430 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 RX430.
Mentions image processing
Yes
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
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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 RX430 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 RX430 performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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Image /page/0/Picture/0 description: The image shows the 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 font below the square.
K 112466
OCT 2 7 2011
E1ZO 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 | August 22nd, 2011 |
Traditional 510(k) Summary (in accordance with 21 CFR 807.92)
-
- Date of Summary August 22nd, 2011
-
- Company EIZO NANAO CORPORATION 153 Shimokashiwano, Hakusan Ishikawa 924-8566 Japan
-
- Authorized Contact Person Hiroaki Hashimoto
4. Device Information
- . Trade Name/Model: RadiForce RX430
- 4MP Color LCD Monitor ● Common Name:
- . 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 RX430 is a 4MP Color LCD monitor for viewing medical images. The matrix size of the color panel, 2560 x 1600 pixels with a pixel pitch of 0.2505 mm corresponds to two 2MP monitors in portrait mode (1200 x 1600 x 2 with a pixel pitch of e.g. 0.270 mm) and provides dual-head configuration without the obtrusive bezel in the center. 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.
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Image /page/1/Picture/0 description: The image shows the logo for EIZO. The logo consists of a stylized square with a checkerboard pattern in the upper right corner. Below the square is the word "EIZO" in a bold, sans-serif font.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including RX430 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 RX430.
7. Intended Use
The RadiForce RX430 is intended to be used in displaying and viewing digital images of X-ray or MRI etc. by trained medical practitioners. The RadiForce RX430 does not support the display of mammography images for diagnosis.
8. Technological Characteristics
RadiForce RX430 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 (4096 x 2560) and the active area sizes (641.3 mm x 400.8 mm) of a. the LCD panels used by the both devices are the same though they are from different manufacturers.
- b. The panel of RadiForce RX430 employs In-Plane Switching (IPS) technology which is well-known for its wider viewing angle than other technologies like Twisted Nematic (TN) or Vertical Alignment (VA) employed by the panel of the predicate device.
- c. Though the RadiForce RX430 and the predicate device employ CCFL backlight technology, the maximum luminance and the recommended or default luminance of the former is much higher.
- d. 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.
- e. As for input video signal, in addition to the Digital Visual Interface (DVI) also supported by the predicate device, RadiForce RX430 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, RX430 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 monitor and the Ambient Light Sensor 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
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Image /page/2/Picture/0 description: The image is a logo for EIZO. The logo features a stylized square with a checkerboard pattern in the upper right corner. The word "EIZO" is written in a bold, sans-serif font below the square.
the use of an external sensor. The precision data of the calibration with external sensors and with the IFS is provided as one of the validation data.
The overall design of the RadiForce RX430 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 RX430 performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.
9. Conclusion
The 4MP color LCD monitor. RadiForce RX430 is substantially equivalent to the predicate device with respect to technical characteristics, application and intended use. The specifications of 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 RX430 contains sufficient information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
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Image /page/3/Picture/0 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
OCT 2 7 2011
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 - Medical System Standards 153 Shimokashiwano Hakusan, Ishikawa, 924-8566 JAPAN
Re: K112466
Trade/Device Name: 4MP Color LCD Monitor, RadForce RX430 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 22, 2011 Received: August 26, 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, insting 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 2007 Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish frinther 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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Enclosure
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. S. 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
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Image /page/5/Picture/0 description: The image shows a logo with a stylized, geometric design above the word "EIZO". The design consists of a square grid pattern in the upper right corner, with the rest of the shape filled in with solid black. The word "EIZO" is in a bold, sans-serif font, with a small trademark symbol to the right of the "O".
Indications for Use
510(k) Number (if known):
Device Name:
4MP Color LCD Monitor, RadiForce RX430
Indications For Use:
The RadiForce RX430 is intended to be used in displaying and viewing digital images of X-ray or MRI etc. by trained medical practitioners. The RadiForce RX430 does not support the display of mammography images for diagnosis.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELQW THIS LINE-CONTINUE ON ANQTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary Slatil
(Division Sign Off)
Division of Radiological Office of In Vitro Diagnostic Device Evaluation
510K K112466
Indications for Use Statement_RX430.doc: Page 1 of 1