(45 days)
Not Found
No
The device description and performance studies focus on the technical specifications and quality control of a medical display monitor and its associated software for image viewing and quality control, with no mention of AI or ML algorithms for image analysis or interpretation.
No.
The device is a medical image display monitor used for review and analysis by medical practitioners, not for treating diseases or conditions.
Yes
Explanation: The device is a "monochrome LCD monitor for viewing medical images" used by "trained medical practitioners" for "review and analysis" of "digital images including those of digital mammography." This purpose aligns with the definition of a diagnostic device, which is used to analyze medical data to inform medical decisions.
No
The primary device described is a monochrome LCD monitor (RadiForce GX540), which is a hardware component. While the submission includes "RadiCS is application software" as an accessory, the core device being cleared is a physical display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 IVDs.
- Device Description: The description details a monochrome LCD monitor designed for viewing medical images. It focuses on display characteristics, calibration, and quality control software. This aligns with the description of a medical display device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens.
- Predicate Device: The predicate device is a "5MP Monochrome LCD Monitor," which is also a medical display device, not an IVD.
In summary, the RadiForce GX540 is a medical display monitor used for viewing and analyzing medical images, which falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
This product 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
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.
Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "GX540" such as "GX540-CLAR", a model whose backlight is Clear Base with an Anti-Reflective coating on the screen surface 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 the RadiForce GX540 based on the QC 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
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital images including those of digital mammography
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 GX540:
- 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 t
- 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
None of the tests revealed behaviors inconsistent with the expected performance.
No animal or clinical testing was performed on the RadiForce GX540.
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
K136336
Page 1 of 4
Image /page/0/Picture/1 description: The image shows the logo for EIZO. The logo consists of a geometric shape on the left and the word "EIZO" on the right. The geometric shape is a square with a checkered pattern on top and a jagged edge on the bottom. The word "EIZO" is in a bold, sans-serif font, and there is a registered trademark symbol after the "O".
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 Hiroaki Hashimoto Medical System Standards
Telephone Fax E-Mail
+81 (76) 274-2468 +81 (76) 274-2484
510(k) Summary (in accordance with 21 CFR 807.92)
1. Company
Eizo Nanao Corporation 153 Shimokashiwano, Hakusan Ishikawa 924-8566 Japan Tel: +81 (76) 274-2468 Fax: +81 (76) 274-2484
2. Contact Person
Hiroaki Hashimoto
3. Date of Summary February 6th, 2013
4. Device Information
- Trade Name/Model: RadiForce GX540 .
- . Common Name: 5MP Monochrome LCD Monitor
- Classification Name: System, Image Processing, Radiological .
- 21 CFR 892.2050, Product Code LLZ Regulation Number: ●
5. Predicate Device
- 5MP Monochrome LCD Monitor, RadiForce GX530 (K112354) .
1
K130336
Page 2 of 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.
Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "GX540" such as "GX540-CLAR", a model whose backlight is Clear Base with an Anti-Reflective coating on the screen surface 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 the RadiForce GX540 based on the QC 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 digital images including those of digital mammography for review and analysis by trained medical practitioners.
8. Comparison of Technological Characteristics
The comparison table below enumerates information derived from the product literature of the each device and different technological characteristics are discussed in it:
| Attributes | Eizo RadiForce
GX540 | Eizo RadiForce
GX530 | Explanation of
Differences |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Display Performance/Specifications | | | |
| Screen
technology | TFT Monochrome LCD
Panel (IPS) | TFT Monochrome LCD
Panel (IPS) | - |
| Viewing
angle (H, V) | H: 176°, V: 176°
@ CR≥10 | H: 170°, V: 170°
@ CR≥50 | Eizo uses typical data for
very low contrast
provided by the panel
manufacturers |
| Active screen
size | 337.9 mm x 422.4 mm | 337.9 mm x 422.4 mm | - |
| Resolution | 5MP (2,048 x 2,560) | 5MP (2,048 x 2,560) | - |
| Aspect ratio | 4:5 | 4:5 | - |
| Pixel pitch | 0.165 mm x 0.165 mm | 0.165 mm x 0.165 mm | - |
| Maximum
luminance | 1,200 cd/m² | 1,200 cd/m² | - |
| DICOM calibrated luminance | 500 cd/m² | 500 cd/m² | |
| Contrast ratio | 1200:1 | 1200:1 | Eizo uses typical contrast ratio data provided by panel manufacturers. |
| Backlighting | LED | CCFL | See main text. |
| Grayscale Tones | 10-bit (DisplayPort):
1,024 from a palette of
16,369 tones
8-bit: 256 from a palette
of 16,369 tones | 10-bit (DisplayPort):
1,024 from a palette of
16,369 tones
8-bit: 256 from a palette
of 16,369 tones | |
| Luminance non-uniformity compensation | Digital Uniformity Equalizer | Digital Uniformity Equalizer | |
| Video Signal Input | | | |
| Input video signals | DVI-D (dual link) x 1,
DisplayPort x 1 | DVI-D (dual link) x 1,
DisplayPort x 1 | |
| Scanning Frequency (H, V) | 31 - 135 kHz / 24 - 61 Hz
Frame synchronous
mode: 24.5 - 25.5 Hz, 49 - 51 Hz | 31 - 135 kHz / 24 - 61 Hz
Frame synchronous
mode: 24.5 - 25.5 Hz, 49 - 51 Hz | |
| Power Related Specifications | | | |
| Power Requirements | AC 100 - 120 V,
200 - 240 V: 50 / 60 Hz | AC 100 - 120 V,
200 - 240 V: 50 / 60 Hz | |
| Power Consumption / Save Mode | 108 W / Less than 0.7 W | 130 W / Less than 2.5 W | The proposed device consumes less power than the predicate device. |
| Power Management | DVI DMPM,
DisplayPort 1.1a | DVI DMPM,
DisplayPort 1.1a | |
| Miscellaneous Features/Specifications | | | |
| QC software | RadiCS | RadiCS | |
| Sensors | Backlight Sensor,
Integrated Front Sensor,
Presence Sensor,
Ambient Light Sensor | Backlight Sensor,
Integrated Front Sensor,
Presence Sensor,
Ambient Light Sensor | |
| USB Ports / Standard | 1 upstream,
2 downstream / Rev. 2.0 | 1 upstream,
2 downstream / Rev. 2.0 | |
| Dimensions w/o stand (W x H x D) | 388 x 496 x 99 mm | 388 x 496 x 99 mm | |
2
KB0336
Page 3 of 4
For the substantial equivalence determination, only the difference of the backlights needs further evidences by performance testing.
.
3
K130336
page 4 of 4
9. Performance Testing
The following bench tests were performed on the RadiForce GX540:
- 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 t
- 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
None of the tests revealed behaviors inconsistent with the expected performance.
No animal or clinical testing was performed on the RadiForce GX540.
10. Conclusion
The 5MP Monochrome LCD Monitor, RadiForce GX540 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.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2013
Eizo Nanao Corporation % Mr. Hiroaki Hashimoto Manager of Medical System Standards Division 153 Shimokashiwano, Hakusan. Ishikawa 924-8566 JAPAN
Re: K130336
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: LLZ Dated: February 5, 2013 Received: February 11, 2013
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 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
5
Page 2 - Mr. Hashimoto
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours.
Smh.p.)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K130336
5MP Monochrome LCD Monitor. RadiForce GX540 Device Name:
Indications for Use:
This product is intended to be used in displaying digital images including those of digital mammography for review and analysis by trained medical practitioners.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
. Smh.7)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K130336
Page 1 of 1