This product is intended to be used in displaying digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

Device Description

RadiForce RX350 is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 1,536 x 2,048 pixels (3MP).

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 "RX350" such as "RX350-AR", a model with an Anti-Reflective coating 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 RX350 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 RX350.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria from an AI performance perspective. The document is a 510(k) premarket notification for a medical display monitor (EIZO RadiForce RX350), not an AI/ML medical device.

The "Performance Testing" section describes bench tests performed on the display monitor to verify its performance characteristics (e.g., DICOM GSDF conformance, luminance, chromaticity, spatial resolution, pixel defects). The conclusion states that "The test results showed that the RadiForce RX350 has display characteristics equivalent to those of the predicate device... Besides, the display characteristics of the RadiForce RX350 meet the pre-defined criteria when criteria are set." However, it does not provide the specific "pre-defined criteria" in a table format with reported device performance, nor does it involve AI/ML performance metrics.

Therefore, I cannot fulfill your request for the specific points related to acceptance criteria for an AI device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.

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

January 12, 2016

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

Re: K153354

Trade/Device Name: 3MP Color LCD Monitor, RadiForce RX350 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: November 16, 2015 Received: November 20, 2015

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.

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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 Ochs

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153354

Device Name

3MP Color LCD Monitor, RadiForce RX350

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 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 shape 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 November 16th, 2015

4. Device Information

Trade Name/Model: RadiForce RX350 ●
3MP Color LCD Monitor ● Common Name:
Classification Name: Display, Diagnostic Radiology ●
21 CFR 892.2050, Product Code PGY ● Regulation Number:

5. Predicate Device

3MP Color LCD Monitor, RadiForce RX340 (K113562) ●

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6. Device Description

7. Intended Use

This product is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

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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	RadiForceRX350	RadiForceRX340	Explanation ofDifferences
Display Performance/Specifications
Screentechnology	Color (IPS)	IPS TFT Color LCDPanel	-
Viewingangle (H, V)	H: 178°, V: 178°	H: 170°, V: 170°	Eizo uses typical data forvery low contrastprovided by the panelmanufacturers
Active screensize	324.9 mm x 433.2 mm	323.7 mm x 431.6 mm	-
Resolution	3MP (1,536 x 2,048)	3MP (1,536 x 2,048)	-
Aspect ratio	3 : 4	3 : 4	-
Pixel pitch	0.2115 mm x 0.2115 mm	0.21075 mm x 0.21075mm	-
Maximumluminance	1,000 cd/m²	1,000 cd/m²	-
DICOMcalibratedluminance	500 cd/m²	400 cd/m²	-
Contrast ratio	1500 : 1	1400 : 1	Eizo uses typical contrastratio data provided bypanel manufacturers.
Backlighting	LED	LED	-
DisplayColors	From a palette of 68billion colors:- 10-bit input(DisplayPort): 1.07billion colors(maximum)- 8-bit input: 16.77million colors	From a palette of 68billion colors:- 10-bit input(DisplayPort): 1.07billion colors(maximum)- 8-bit input: 16.77million colors	-
Luminancenon-uniformitycompensation	Digital UniformityEqualizer	Digital UniformityEqualizer	-
Video Signals
Input videosignals	DVI-D (dual link) x 1,DisplayPort x 1	DVI-D (dual link) x 1,DisplayPort x 1	-
Output videosignals	DisplayPort x 1 (daisychain)
ScanningFrequency(H, V)	31 - 127 kHz / 29 - 61.5Hz (VGA Text: 69 - 71Hz)Frame synchronousmode: 29.5 - 30.5 Hz, 59- 61 Hz	31 - 127 kHz, 29 - 61 Hz(VGA Text: 69 - 71 Hz)Frame synchronousmode: 29.5 - 30.5 Hz,59 - 61 Hz	-
Power Related Specifications
PowerRequirements	AC 100 - 240 V: 50 / 60Hz	AC 100 - 120 V,200 - 240 V: 50 / 60 Hz	-
PowerConsumption/ Save Mode	89 W / Less than 1 W	125 W / Less than 3 W	-
PowerManagement	DVI DMPM,DisplayPort 1.2a	DVI DMPM,DisplayPort 1.1a	-
Miscellaneous Features/Specifications
QC software	RadiCS	RadiCS	-
Sensors	Backlight Sensor,Presence SensorIntegrated Front Sensor,Ambient Light Sensor	Backlight Sensor,Presence Sensor,Integrated Front Sensor,Ambient Light Sensor	-
USB Ports /Standard	1 upstream,2 downstream / Rev. 2.0	1 upstream,2 downstream / Rev. 2.0	-
Dimensionsw/o stand(W x H x D)	354 x 462 x 78 mm	376 x 505 x 98 mm	-

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It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the RX350.

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9. Performance Testing

The following bench tests were performed on the RadiForce RX350.

. 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 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
. Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline
Measurement of spatial resolution expressed as modulation transfer function (MTF)
. The maximum number allowed for each type of pixel defects/faults

The test results showed that the RadiForce RX350 has display characteristics equivalent to those of the predicate device. RadiForce RX340 except one item, which was determined that it would not affect observer's performance.

Besides, the display characteristics of the RadiForce RX350 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce RX350.

10. Conclusion

The RadiForce RX350 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.
. The bench tests demonstrated that the display characteristics are equivalent to those of the predicate device except one item, which was determined that it would not affect observer's performance.

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).