(21 days)
No
The description focuses on the hardware (monitor) and quality control software, with no mention of AI or ML for image analysis or interpretation.
No
Explanation: This device is a monitor used for displaying medical images for review and diagnosis, not for direct therapeutic intervention on a patient.
Yes
Explanation: The "Intended Use / Indications for Use" states that the product is intended for "diagnosis by trained medical practitioners," and the "Device Description" mentions that it is a "monochrome LCD monitor for viewing medical images." The "Input Imaging Modality" also specifies its use for "digital mammography, for review, and diagnosis." The product is a display device used for the diagnostic interpretation of medical images.
No
The device description clearly states that the RadiForce GX540 is a monochrome LCD monitor, which is a hardware component. While it includes software (RadiCS) as an accessory, the primary device being submitted is a physical display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The RadiForce GX540 is a display monitor used for viewing medical images. It does not perform any tests on biological samples. Its function is to present digital images generated by other medical devices (like mammography systems) for interpretation by medical practitioners.
- Intended Use: The intended use clearly states it's for "displaying and viewing digital images... for review, and diagnosis." This is a display function, not an in vitro diagnostic test.
Therefore, the RadiForce GX540 falls under the category of a medical device, specifically a display accessory for medical imaging, but it is not an IVD.
N/A
Intended Use / Indications for Use
This product is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
Product codes
PGY
Device Description
RadiForce GX540 is a monochrome LCD monitor for viewing medical images including those of mammography. The monochrome panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 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.
There are two model variations, GX540-CL and GX540-CLAR (GX540 without any suffix does not exist). The difference of the two variations is the surface treatment of the display screens; the surface treatment of the GX540-CL is Anti-Glare (AG) treatment and that of the GX540-CLAR is Anti-Reflection (AR) coating. The suffix common to the both variations, " - CL", means that the tint of the backlight is Clear Base (vs. Blue Base, another popular tint slightly bluish).
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce GX540 based on the OC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce GX540.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital images, including standard and multi-frame digital mammography, breast tomosynthesis
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
The following bench tests were performed on the RadiForce GX540 following instructions in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions:
- 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 angular dependency of luminance response in horizontal, vertical and diagonal directions
- Measurement of the luminance non-uniformity characteristics of the display screen as specified in TG18 guideline
- Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline
- Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance
- Measurement of display reflections including specular, diffuse and haze components
- Measurement of small-spot contrast ratio
- Measurement of spatial resolution expressed as modulation transfer function (MTF)
- Measurement of noise expressed as noise power spectrum (NPS)
- Measurement of pixel aperture ratio
- Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline
- Measurement of temporal response
- Performance data on luminance stability
- The maximum number allowed for each type of pixel defects/faults agreed with the manufacturer from which EIZO buys the LCD panels for RadiForce GX540
The test results showed that the display characteristics of the RadiForce GX540 meet the pre-defined criteria when criteria are set.
The goal of the clinical testing was to assess the image quality of tomosynthesis images on the proposed device compared to that on the predicate device.
The results of the testing indicated that the proposed device is at least equivalent to the predicate device for viewing tomosynthesis images, especially lesions like masses, microcalcifications and architectural distortions within the images.
Key Metrics
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 30, 2015
EIZO Corporation % Hiroaki Hashimoto Manager 153 Shimokashiwano Hakusan, 924-8566 JAPAN
Re: K151883
Trade/Device Name: 5MP Monochrome LCD Monitor, RadiForce GX540 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: July 3, 2015 Received: July 9, 2015
Dear Hiroaki 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151883
Device Name
5MP Monochrome LCD Monitor, RadiForce GX540
Indications for Use (Describe)
This product is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the EIZO logo. The logo consists of a stylized square shape with a checkered pattern on the left and the word "EIZO" in bold, sans-serif font on the right. The square shape has a wavy top edge and a jagged bottom edge. The word "EIZO" is followed by the registered trademark symbol.
EIZO Corporation, 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Janan
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
Hiroaki Hashimoto Medical System Standards
Telephone Fax E-Mail
+81 (76) 274-2468 +81 (76) 274-2484 hiroaki.hashimoto@eizo.com
510(k) Summary (in accordance with 21 CFR 807.92)
1. Company
EIZO Corporation 153 Shimokashiwano, Hakusan Ishikawa 924-8566 Japan Tel: +81 (76) 274-2468 Fax: +81 (76) 274-2484
Contact Person 2.
Hiroaki Hashimoto
3. Date of Summary
July 3rd, 2015
●
●
4. Device Information
- Trade Name/Model: RadiForce GX540 ●
- 5MP Monochrome LCD Monitor ● Common Name:
- Classification Name: Display, Diagnostic Radiology
- 21 CFR 892.2050, Product Code PGY Regulation Number:
- 510(k) Number: K130336 (for digital mammography) ●
5. Predicate Device
- Trade/Device Name: ●
- 510(k) Number: ●
Barco Mammo Tomosynthesis (MDMG-5221) K103792
4
6. Device Description
RadiForce GX540 is a monochrome LCD monitor for viewing medical images including those of mammography. The monochrome panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 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.
There are two model variations, GX540-CL and GX540-CLAR (GX540 without any suffix does not exist). The difference of the two variations is the surface treatment of the display screens; the surface treatment of the GX540-CL is Anti-Glare (AG) treatment and that of the GX540-CLAR is Anti-Reflection (AR) coating. The suffix common to the both variations, " - CL", means that the tint of the backlight is Clear Base (vs. Blue Base, another popular tint slightly bluish).
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce GX540 based on the OC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce GX540.
7. Intended Use
This product is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
5
Comparison of Technological Characteristics 8.
The comparison table below enumerates information derived from the product brochure of the each device and other differences are discussed:
| Attributes | EIZO RadiForce
GX540 | Barco MDMG-5221 | Explanation of
Differences |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display Performance/Specifications | | | |
| Response
Time
(typical) | 25 ms (On/Off) | 15 ms (Tr + Tf) | EIZO uses typical data
provided by the panel
manufacturer.
See main text for further
explanation. |
| Resolution or
Matrix Size | 5MP (2,048 x 2,560) | 5MP (2,048 x 2,560) | - |
| Screen
Technology | TFT Monochrome
LCD Panel (IPS) | TFT (Monochrome)
AMLCD Dual Domain
IPS WideView | - |
| Backlighting | LED | CCFL | See main text for further
explanation. |
| Maximum
Luminance | 1,200 cd/m² | 2,100 cd/m² | The luminance ratio (max/min)
between 250 and 650 generally
recommended taking account
of the contrast sensitivity of
human eyes is available in the
proposed devices. EIZO does
not see merits of the extremely
high luminance offering
contrast beyond what the eyes
can see. |
| DICOM
Calibrated
Luminance | 500 cd/m² | 1,000 cd/m² | - |
| Viewing
Angle (H, V) | H: 176°, V: 176° | 176° | - |
| Active
Screen Size | 337.9 mm x 422.4 mm | 337.9 mm x 422.4 mm | - |
| Aspect Ratio | 4:5 | 4:5 | - |
| Pixel Pitch | 0.165 mm x 0.165 mm | 0.165 mm x 0.165 mm | - |
| Contrast
Ratio | 1200:1 | 950:1 | - |
| Grayscale
Tones | 10-bit (DisplayPort): 1,024
from a palette of 16,369
tones
8-bit: 256 from a palette of
16,369 tones | Number of grayscales
(LUT in/LUT out):
1024 gray levels (10/12) | - |
| Attributes | EIZO RadiForce
GX540 | Barco MDMG-5221 | Explanation of
Differences |
| Non-
Uniformity
Compensation | Digital Uniformity
Equalizer (DUE) | Per Pixel Uniformity | The both features are intended to
improve uniformity of
brightness and color. |
| Video Signal Input | | | |
| Input Video
Signals | DVI-D (dual link) x 1,
DisplayPort x 1 | DVI, DisplayPort | - |
| Scanning
Frequency
(H, V) | 31 - 135 kHz / 24 - 61 Hz
Frame synchronous
mode: 24.5 - 25.5 Hz, 49
- 51 Hz | 30-150 kHz; 15-80 Hz | - |
| Dot Clock | 290 MHz | 280 MHz | - |
| Power Related Specifications | | | |
| Power
Requirements | AC 100 - 120 V,
200 - 240 V: 50 / 60 Hz | 100 - 240 V | - |
| Power
Consumption | 108 W / Less than 0.7 W | 125 W (nominal) | - |
| Power
Management | DVI DMPM,
DisplayPort 1.1a | DVI-DMPM | - |
| Miscellaneous Features/Specifications | | | - |
| QC Software | RadiCS | MediCal QAWeb | - |
| Sensors | Integrated Front Sensor
(IFS) | I-Guard | The both sensors/technologies
enable automatic grayscale
check and calibration by
measuring the luminance at the
screen surface. |
| | Backlight Sensor (BS) | Backlight Output
Stabilization (BLOS)? | BS enables backlight
brightness stabilization by
measuring the backlight
brightness directly and the
feature is very common to
medical displays.
The implementation of BLOS
on the predicate device is not
certain though the feature is
mentioned in the overall
products brochure. |
| | Ambient Light Sensor
(ALS) | Hemispherical Ambient
Light Sensor | - |
| Attributes | EIZO RadiForce
GX540 | Barco MDMG-5221 | Explanation of
Differences |
| | Presence Sensor (PS) | - | PS detects the absence of the
user as a trigger of the power
saving mode. |
| USB Ports /
Standard | 1 upstream,
2 downstream / Rev. 2.0 | 1 upstream + 1 endpoint,
2 downstream / Rev. 2.0 | - |
| Dimensions
w/o Stand
(W x H x D) | 388 x 496 x 99 mm | 392 x 484 x 123 mm | Different housing design due
to the different panel size. |
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For the substantial equivalence determination, only the difference of the response time needs further evidences by performance testing for the proposed additional usage, "multi-frame digital mammography" or "digital breast tomosynthesis".
8
9. Performance Testing
9.1. Bench Testing
The following bench tests were performed on the RadiForce GX540 following instructions in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions:
- 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 angular dependency of luminance response in horizontal, vertical and diagonal directions
- . Measurement of the luminance non-uniformity characteristics of the display screen as specified in TG18 guideline
- Measurement of the chromaticity non-uniformity characteristics of the display screen . as specified in TG18 guideline
- . Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance
- Measurement of display reflections including specular, diffuse and haze components ●
- Measurement of small-spot contrast ratio
- . Measurement of spatial resolution expressed as modulation transfer function (MTF)
- . Measurement of noise expressed as noise power spectrum (NPS)
- Measurement of pixel aperture ratio
- Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline
- . Measurement of temporal response
- Performance data on luminance stability ●
- The maximum number allowed for each type of pixel defects/faults agreed with the . manufacturer from which EIZO buys the LCD panels for RadiForce GX540
The test results showed that the display characteristics of the RadiForce GX540 meet the pre-defined criteria when criteria are set.
The corresponding testing data of the predicate device, Barco Mammo Tomosynthesis (MDMG-5221), was not available because the device is from other manufacturer.
9.2. Clinical Testing
The goal of the clinical testing was to assess the image quality of tomosynthesis images on the proposed device compared to that on the predicate device.
The results of the testing indicated that the proposed device is at least equivalent to the predicate device for viewing tomosynthesis images, especially lesions like masses, microcalcifications and architectural distortions within the images.
9
9.3. Animal Testing
No animal testing was performed on the RadiForce GX540.
Conclusion 10.
The RadiForce GX540 was determined to be substantially equivalent to the predicate device due to the following reasons:
- The stated intended use is substantially the same as that of the predicate device.
- It was confirmed that the technological characteristics different from those of the . predicate device do not affect the safety and the effectiveness except one item, which was determined that it would not affect observer's performance based on the results of the clinical testing.