Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the monitor's display technology, calibration, and quality control software, with no mention of AI or ML capabilities for image analysis or processing.

Therapeutic

No
This device is a color LCD monitor used for displaying digital images for review, analysis, and diagnosis by medical practitioners; it does not directly provide therapy.

Diagnostic

No

Explanation: The device is a medical display monitor intended for viewing images for review, analysis, and diagnosis, but it does not perform the diagnostic function itself. It displays the images that trained medical practitioners use for diagnosis.

SaMD (Software as a Medical Device)

No

The primary device described is a color LCD monitor (RadiForce RS340), which is a hardware device. While the submission includes software (RadiCS) as an accessory, the core device is not software-only.

IVD (In Vitro Diagnostic)

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 RS340 is a medical monitor used for displaying digital images for review, analysis, and diagnosis. It is a display device, not a test that analyzes biological samples.
Intended Use: The intended use clearly states it's for "displaying digital images for review, analysis and diagnosis." This aligns with the function of a medical monitor, not an IVD.
Device Description: The description details the technical specifications of the monitor (LCD, resolution, tone curves, etc.) and associated software for quality control. There is no mention of analyzing biological samples.

Therefore, the RadiForce RS340 falls under the category of a medical imaging display device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

PGY

Device Description

RadiForce RS340 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 with the matrix size (or resolution) of 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.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RS340 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 RS340.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

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 RS340.

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 the TG18 guideline
Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in the TG18 guideline
Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance as specified in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions
. Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in the 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 RS340 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 RS340 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce RS340.

Key Metrics

Not Found

Predicate Device(s)

RadiForce RX340 (K113562)

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 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.

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

November 18, 2014

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

Re: K143098

Trade/Device Name: 3MP Color LCD Monitor, RadiForce RS340 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: October 24, 2014 Received: October 28, 2014

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,

for

Janine M. Morris 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) K143098

Device Name 3MP Color LCD Monitor, RadiForce RS340

Indications for Use (Describe)

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.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 logo for EIZO. The logo consists of a stylized, geometric shape on the left and the word "EIZO" in bold, sans-serif letters on the right. The geometric shape is a square divided into smaller squares, with a wavy edge at the top. The "O" in "EIZO" has a registered trademark symbol next to it.

EIZO 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

Hiroaki Hashimoto Name Department 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 14th, 2014

4. Device Information

RadiForce RS340 ● Trade Name/Model:
Common Name: 3MP Color LCD Monitor ●
Classification Name: Display, Diagnostic Radiology .
Regulation Number: 21 CFR 892.2050, Product Code PGY ●

5. Predicate Device

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

4

6. Device Description

RadiForce RS340 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 with the matrix size (or resolution) of 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.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RS340 based on the OC 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 RS340.

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.

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:

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| Attributes | RadiForce
RS340 | RadiForce
RX340 | Explanation of
Differences |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display Performance/Specifications | | | |
| Screen
technology | IPS TFT Color LCD
Panel | IPS TFT Color LCD
Panel | |
| Viewing
angle (H, V) | H: 176°, V: 176° | H: 170°, V: 170° | Eizo uses typical data for
very low contrast
provided by the panel
manufacturers |
| Active screen
size | 324.8 mm x 433.1 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 | 0.211 mm x 0.211 mm | 0.21075 mm x 0.21075
mm | - |
| Maximum
luminance | 800 cd/m² | 1,000 cd/m² | Though the smaller
maximum luminance
value usually results in
shorter period during
which the calibrated
luminance can be
guaranteed, the
guaranteed operating
periods of the both
devices are the same. |
| DICOM
calibrated
luminance | 400 cd/m² | 400 cd/m² | - |
| Contrast ratio | 1400 : 1 | 1400 : 1 | Eizo uses typical contrast
ratio data provided by
panel manufacturers. |
| Backlighting | LED | LED | - |
| Display
Colors | From a palette of 68
billion colors:

10-bit input
(DisplayPort): 1.07
billion colors
(maximum)
8-bit input: 16.77
million colors | From a palette of 68
billion colors:
10-bit input
(DisplayPort): 1.07
billion colors
(maximum)
8-bit input: 16.77
million colors | - |
| 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 - 127 kHz / 29 - 61.5
Hz (VGA Text: 69 - 71
Hz)
Frame synchronous
mode: 29.5 - 30.5 Hz, 59
61 Hz | 31 - 127 kHz, 29 - 61 Hz
(VGA Text: 69 - 71 Hz)
Frame synchronous
mode: 29.5 - 30.5 Hz,
59 - 61 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 | 110 W / Less than 1.6 W | 125 W / Less than 3 W | The proposed device
consumes less power than
the predicate device in
the power saving mode. |
| Power
Management | DVI DMPM,
DisplayPort 1.1a | DVI DMPM,
DisplayPort 1.1a | - |
| Miscellaneous Features/Specifications | | | |
| QC software | RadiCS | RadiCS | - |
| Sensors | Backlight Sensor,
Presence Sensor | Backlight Sensor,
Presence Sensor,
Integrated Front Sensor
(IFS),
Ambient Light Sensor | For the predicate device
without IFS, the use of an
external sensor is
assumed for QC tests and
calibration. |
| 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) | 376 x 505 x 98 mm | 376 x 505 x 98 mm | - |

6

It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the RS340.

7

9. Performance Testing

The following bench tests were performed on the RadiForce RS340.

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 the TG18 guideline
Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in the TG18 guideline
Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance as specified in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions
. Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in the 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 RS340 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 RS340 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce RS340.

10. Conclusion

The RadiForce RS340 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.