Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a medical display monitor and associated quality control software. The description focuses on display characteristics and performance, with no mention of AI or ML for image analysis or processing.

Therapeutic

No
The device is a monitor used for displaying and viewing medical images for review, analysis, and diagnosis, not for treating a condition.

Diagnostic

Yes
The product is intended for "review, analysis and diagnosis by trained medical practitioners," indicating its role in the diagnostic process.

SaMD (Software as a Medical Device)

No

The device description clearly states that the primary device is a monochrome LCD monitor (RadiForce GX550), which is a hardware component. While it includes software (RadiCS) as an accessory, the core device being submitted is hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens from the human body. The intended use of the RadiForce GX550 is to display and view digital images, specifically medical images like mammograms, for diagnosis. It does not involve the analysis of biological samples.
The device description focuses on display technology and image characteristics. The description details the monitor's resolution, panel type, calibration, and surface treatment. These are features related to image presentation, not the analysis of biological specimens.
The performance studies are related to display quality and characteristics. The bench tests performed evaluate aspects like DICOM conformance, luminance, uniformity, and resolution – all related to the visual display of images. There are no studies involving the analysis of biological samples or their components.

The RadiForce GX550 is a medical device, specifically a diagnostic display monitor, but it falls under a different regulatory category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

Product codes

PGY

Device Description

RadiForce GX550 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, GX550 and GX550-AR. The difference of the two variations is the surface treatment of the GX550 is Anti-Glare (AG) treatment and that of the GX550-AR is Anti-Reflection (AR) coating.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce GX550 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset, RadiCS LE, are included in this 510(k) submission as an accessory to the RadiForce GX550.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

digital images, standard and multi-frame digital mammography, breast tomosynthesis

Anatomical Site

Breast

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 bench tests were performed on the RadiForce GX550 following the 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

The test results showed that the RadiForce GX550 has display characteristics equivalent to those of the predicate device, RadiForce GX540.
Besides, the display characteristics of the RadiForce GX550 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce GX550.

Key Metrics

Not Found

Predicate Device(s)

K151883

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 19, 2016

EIZO Corporation % Mr. Hiroaki Hashimoto Manager 153 Shimokashiwano Hakusan, Ishikawa 924-8566 JAPAN

Re: K162497

Trade/Device Name: 5MP Monochrome LCD Monitor, Radiforce GX550, GX550-AR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: September 2, 2016 Received: September 7, 2016

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. 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.

Michael D'Hara

For

Robert Ochs, Ph.D. 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) K162497

Device Name

5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR

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, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CER 801 Subpart D)
☐ Over-The-Counter Use (21 CER 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the EIZO logo. The logo consists of a stylized square with a checkered pattern on the left and the word "EIZO" in bold, sans-serif font on the right. A registered trademark symbol is located to the upper right of the "O" in "EIZO".

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

2. Contact Person

Hiroaki Hashimoto

1. Date of Summary September 2nd, 2016

4. Device Information

Trade Name/Model: RadiForce GX550, GX550-AR ●
Common Name: 5MP Monochrome LCD Monitor
Classification Name: Display, Diagnostic Radiology ●
21 CFR 892.2050, Product Code PGY ● Regulation Number:

5. Predicate Device

5MP Monochrome LCD Monitor, RadiForce GX540 (K151883) ●

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6. Device Description

RadiForce GX550 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, GX550 and GX550-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the GX550 is Anti-Glare (AG) treatment and that of the GX550-AR is Anti-Reflection (AR) coating.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce GX550 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset, RadiCS LE, are included in this 510(k) submission as an accessory to the RadiForce GX550.

7. 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, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

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8. Comparison of Technological Characteristics

The comparison table below enumerates information derived from the product brochure of the each device and different technological characteristics are discussed in it:

| Attributes | RadiForce GX550 | RadiForce GX540 | Explanation of
Differences |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display Performance/Specifications | | | |
| Screen
technology | TFT Monochrome
LCD Panel (IPS) | TFT Monochrome
LCD Panel (IPS) | - |
| Viewing angle
(H, V) | H: 178°, V: 178° | H: 176°, V: 176° | - |
| Resolution | 5MP (2,048 x 2,560) | 5MP (2,048 x 2,560) | - |
| Aspect ratio | 4 : 5 | 4 : 5 | - |
| Active screen
size | 337.9 mm x 422.4 mm | 337.9 mm x 422.4 mm | - |
| Pixel pitch | 0.165 mm x 0.165 mm | 0.165 mm x 0.165 mm | - |
| Maximum
luminance | 2,000 cd/m² | 1,200 cd/m² | - |
| DICOM
calibrated
luminance | 600 cd/m² | 500 cd/m² | - |
| Contrast ratio | 1500 : 1 | 1200:1 | - |
| Response
Time (typical) | 25 ms (On/Off) | 25 ms (On/Off) | - |
| Backlighting | LED | LED | - |
| 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 Signals | | | |
| Input video
signals | DVI-D (dual link) x 1,
DisplayPort x 1 | DVI-D (dual link) x 1,
DisplayPort x 1 | - |
| Output
video
signals | DisplayPort x 1 (daisy
chain) | - | - |
| Scanning
Frequency (H,
V) | 31 - 135 kHz / 23 - 61 Hz
Frame synchronous mode:
23.5 - 25.5 Hz, 47 - 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 - 240 V:
50 / 60 Hz | AC 100 - 120 V,
200 - 240 V: 50 / 60 Hz | - |
| Power
Consumption /
Save Mode | 95 W / Less than 1 W | 108 W / Less than 0.7 W | Compared with the
predicate device, the
proposed device
consumes less power in
the operating mode and
more power in the power
saving mode. |
| Power
Management | DVI DMPM,
DisplayPort 1.2a | 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) | 367 x 452 x 78 mm | 388 x 496 x 99 mm | Different housing design. |

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It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the GX550.

7

9. Performance Testing

The bench tests below were performed on the RadiForce GX550 following the 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

The test results showed that the RadiForce GX550 has display characteristics equivalent to those of the predicate device, RadiForce GX540.

Besides, the display characteristics of the RadiForce GX550 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce GX550.

10. Conclusion

The RadiForce GX550 was determined to be substantially equivalent to the predicate device due to the following reasons:

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. The stated intended use is completely the same as that of the predicate device.
. It was confirmed that the technological characteristics differences from those of the predicate device do not affect the safety or the effectiveness.

The bench tests demonstrated that the display characteristics are equivalent to those of the predicate device.