RadiForce MX317W-PA

K242545 · Eizo Corporation · PZZ · May 23, 2025 · Pathology

Device Facts

• Record ID: K242545
• Device Name: RadiForce MX317W-PA
• Applicant: Eizo Corporation
• Product Code: PZZ · Pathology
• Decision Date: May 23, 2025
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 864.3700
• Device Class: Class 2

Intended Use

RadiForce MX317W-PA is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software that have been validated for use with this device. RadiForce MX317W-PA is an aid to the pathologist and is used for review and interpretation of histopathology slides for the purposes of primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using this product. The display is not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.

Device Story

RadiForce MX317W-PA is a 30.5-inch color LCD monitor for viewing digital histopathology images. Input signals are received via USB Type-C, DisplayPort, or HDMI from IVD-labeled whole-slide imaging scanners and viewing software. The device utilizes an IPS panel with 4,096 x 2,160 resolution. It features factory-calibrated display modes stored in internal lookup tables to ensure consistent tone curves. An integrated optical sensor and RadiCS software manage color calibration and ambient light adaptation. The monitor is used by pathologists in clinical settings to aid in primary diagnosis. The device provides high-resolution visual output, enabling the pathologist to perform diagnostic review. Benefits include standardized image display and consistent color/luminance performance, supporting accurate interpretation of histopathology slides.

Clinical Evidence

Bench testing only. Performance characteristics evaluated per FDA TPA guidance, including MTF, luminance, grayscale, color gamut, and reflection. MTF > 92.7% at Nyquist frequency; sRGB coverage 99.2%. No clinical data provided.

Technological Characteristics

TFT Color IPS LCD panel; 30.5" viewable area; 17:9 aspect ratio; LED backlight; 0.1674 mm pixel pitch; RGB vertical stripe subpixel pattern. Connectivity: USB-C, DisplayPort, HDMI. Integrated optical sensor for calibration. Software: RadiCS for ambient light and color management. Sterilization: N/A.

Indications for Use

Indicated for pathologists to review and interpret digital histopathology images for primary diagnosis. Not for use with frozen section, cytology, or non-FFPE hematopathology specimens.

Regulatory Classification

Identification

The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides. The system generates digital images that would otherwise be appropriate for manual visualization by conventional light microscopy.

Special Controls

A whole slide imaging system must comply with the following special controls: (1) Premarket notification submissions must include the following information: (i) The indications for use must specify the tissue specimen that is intended to be used with the whole slide imaging system and the components of the system. (ii) A detailed description of the device and bench testing results at the component level, including for the following, as appropriate: (A) Slide feeder; (B) Light source; (C) Imaging optics: (D)Mechanical scanner movement; (E) Digital imaging sensor; (F) Image processing software; (G)Image composition techniques; (H)Image file formats; (I) Image review manipulation software; (J) Computer environment; (K)Display system. (iii)Detailed bench testing and results at the system level, including for the following, as appropriate: (A)Color reproducibility; (B) Spatial resolution; (C) Focusing test; (D) Whole slide tissue coverage; (E) Stitching error: (F) Turnaround time. (iv) Detailed information demonstrating the performance characteristics of the device, including, as appropriate: (A)Precision to evaluate intra-system and inter-system precision using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included. (B) Reproducibility data to evaluate inter-site variability using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included. (C) Data from a clinical study to demonstrate that viewing, reviewing, and diagnosing digital images of surgical pathology slides prepared from tissue slides using the whole slide imaging system is non-inferior to using an optical microscope. The study should evaluate the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference (e.g., main sign-out diagnosis). (D) A detailed human factors engineering process must be used to evaluate the whole slide imaging system user interface(s). (2) Labeling compliant with 21 CFR 809.10(b) must include the following: The intended use statement must include the information described in paragraph (i) (1)(i) of this section, as applicable, and a statement that reads, "It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using this device." (ii) A description of the technical studies and the summary of results, including those that relate to paragraph (1)(ii) and (1)(iii) of this section, as appropriate. (iii) A description of the performance studies and the summary of results, including those that relate to paragraph (1)(iv) of this section, as appropriate. (iv) A limiting statement that specifies that pathologists should exercise professional judgment in each clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately render an interpretation using this device alone.

*Classification.* Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the following information: (i) The indications for use must specify the tissue specimen that is intended to be used with the whole slide imaging system and the components of the system. (ii) A detailed description of the device and bench testing results at the component level, including for the following, as appropriate: (A) Slide feeder; (B) Light source; (C) Imaging optics; (D) Mechanical scanner movement; (E) Digital imaging sensor; (F) Image processing software; (G) Image composition techniques; (H) Image file formats; (I) Image review manipulation software; (J) Computer environment; and (K) Display system. (iii) Detailed bench testing and results at the system level, including for the following, as appropriate: (A) Color reproducibility; (B) Spatial resolution; (C) Focusing test; (D) Whole slide tissue coverage; (E) Stitching error; and (F) Turnaround time. (iv) Detailed information demonstrating the performance characteristics of the device, including, as appropriate: (A) Precision to evaluate intra-system and inter-system precision using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included. (B) Reproducibility data to evaluate inter-site variability using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included. (C) Data from a clinical study to demonstrate that viewing, reviewing, and diagnosing digital images of surgical pathology slides prepared from tissue slides using the whole slide imaging system is non-inferior to using an optical microscope. The study should evaluate the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference ( *e.g.,* main sign-out diagnosis).(D) A detailed human factor engineering process must be used to evaluate the whole slide imaging system user interface(s). (2) Labeling compliant with 21 CFR 809.10(b) must include the following: (i) The intended use statement must include the information described in paragraph (b)(1)(i) of this section, as applicable, and a statement that reads, “It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using this device.” (ii) A description of the technical studies and the summary of results, including those that relate to paragraphs (b)(1)(ii) and (iii) of this section, as appropriate. (iii) A description of the performance studies and the summary of results, including those that relate to paragraph (b)(1)(iv) of this section, as appropriate. (iv) A limiting statement that specifies that pathologists should exercise professional judgment in each clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately render an interpretation using this device alone.

Predicate Devices

• MDPC-8127 (K203364)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K242545

B Applicant

EIZO Corporation

C Proprietary and Established Names

RadiForce MX317W-PA

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PZZ | Class II | 21 CFR 864.3700 - Whole Slide Imaging System | PA - Pathology |

## II Review Summary:

A Purpose for Submission:

New digital pathology display

B Type of Test:

Digital Pathology Display

## III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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## B Indication(s) for Use:

RadiForce MX317W-PA is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software that have been validated for use with this device.

RadiForce MX317W-PA is an aid to the pathologist and is used for review and interpretation of histopathology slides for the purposes of primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using this product. The display is not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.

## C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

## IV Device/System Characteristics:

### A Device Description:

RadiForce MX317W-PA is a color LCD monitor for viewing digital images of histopathology slides. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles. The display characteristics and specifications are provided in the following table.

Display Characteristics

| Technological characteristics of the display device | |
| --- | --- |
| | TFT Color LCD Panel (IPS) |
| Physical size of the viewable area and aspect ratio | |
| | 77.5cm / 30.5"
Aspect ratio: 17 : 9 |
| Backlight type and properties including temporal, spatial, and spectral characteristics | |
| | LED |
| Frame rate and refresh rate | |
| Digital Scanning Frequency (H / V) | USB Type-C: 31 - 134 kHz / 59 - 61 Hz
DisplayPort: 31 - 134 kHz / 59 - 61 Hz
HDMI: 31 - 136 kHz / 59 - 61 Hz |
| Pixel array, pitch, pixel aperture ratio and subpixel matrix scheme | |
| Pixel pitch | 0.1674 mm x 0.1674 mm |
| Subpixel pattern | RGB Vertical Stripe |
| Pixel aperture ratio | 0.571 |

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| Subpixel driving to improve grayscale resolution (e.g., spatial and temporal dithering) | |
| --- | --- |
| Independent Subpixel drive | OFF |
| Dithering | LCD Specification: True 10-bit color
Multi-gradation is achieved by 3-bit FRC signal processing inside the monitor |
| Display Interface | |
| Input video signals | USB Type-C (DisplayPort Alt Mode) x 1
DisplayPort x 2
HDMI x 1 |
| Output video signals | USB Type-C (daisy chain) x 1 |
| Ambient light adaptation including the ambient light sensing method, instrumentation, and software tool description | |
| Ambient light sensor | Photo Diode
Position: In the upper bezel of the screen
Software tool: RadiCS |
| Color calibration tools (sensor hardware and associated software), color profile, and method for color management | |
| | Integrated optical sensor or external optical sensor controlled by the RadiCS software |

V Substantial Equivalence Information:

A Predicate Device Name(s):

Barco MDPC-8127

B Predicate 510(k) Number(s):

K203364

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K242545 | K203364 |
| --- | --- | --- |
| Device Trade Name | RadiForce MX317W-PA | Barco MDPC-8127 |
| General Device Characteristic Similarities | | |
| Intended Use/Indications for Use | RadiForce MX317W-PA is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital | The Barco MDPC-8127 device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled |

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| Device & Predicate Device(s): | K242545 | K203364 |
| --- | --- | --- |
| | pathology image viewing software that have been validated for use with this device. RadiForce MX317W-PA is an aid to the pathologist and is used for review and interpretation of histopathology slides for the purposes of primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using this product. The display is not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens. | digital pathology image viewing software that have been validated for use with this device. It is an aid to the pathologist to review and interpret digital images of histopathology slides for primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using the MDPC-8127. The display is not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens. |
| Backlight type and properties including temporal, spatial, and spectral characteristics | LED | LED |
| Subpixel pattern | RGB Vertical Stripe | RGB Vertical Stripe |
| Independent Subpixel drive | Off | Off |
| Technological characteristics of the display device | TFT Color In-Plane Switching (IPS) Liquid Crystal Display (LCD) | Color In-Plane Switching (IPS) Liquid Crystal Display (LCD) |
| **General Device Characteristic Differences** | | |
| Physical size of the viewable area and aspect ratio | 77.5 cm / 30.5"
Aspect ratio: 17:9 | 68.4 cm / 27"
Aspect ratio: 16:9 |
| Pixel aperture ratio | 0.571 | 0.502 |

VI Standards/Guidance Documents Referenced:

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1. FDA Guidance document: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices. Guidance for Industry and Food and Drug Administration Staff. April 20, 2016 (TPA Guidance).
2. ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021].
3. ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021].
4. IEC TR 60601-4-2 Edition 1.0 2016-05.
5. IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION.

## VII Performance Characteristics (if/when applicable):

### A Analytical Performance:

1. Precision/Reproducibility: Not applicable.
2. Linearity: Not applicable.
3. Analytical Specificity/Interference: Not applicable.
4. Accuracy (Instrument): Not applicable.
5. Carry-Over: Not applicable.

### B Other Supportive Instrument Performance Characteristics Data:

Technical performance testing for RadiForce MX317W-PA display was performed according to the TPA guidance (section IV(A)(11)(b)). Bench testing included assessment of the following performance characteristics:

| Test | Test Method | Results | |
| --- | --- | --- | --- |
| | | MX317W-PA | MDPC-8127 |
| User controls | N/A | Luminance target, maximum: 370 cd/m² | Luminance target, maximum: 450 cd/m² |
| | | Display function: sRGB | Display function: sRGB |
| | | White point: 6500K | White point: 6500K |
| | | Color space: sRGB | Color space: sRGB |

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| Test | Test Method | Results | |
| --- | --- | --- | --- |
| | | MX317W-PA | MDPC-8127 |
| | | Mode: Patho | |
| Spatial resolution | The spatial resolution or Modulation Transfer Function (MTF) is measured and calculated by using the method proposed in “Novel MTF Measurement Method for Medical Image Viewers Using a Bar Pattern Image” by Katsuhiro Ichikawa et al. in Proceedings of SPIE Vol. 5029, pp.624-631 (2003)". | Both horizontal and vertical MTFs are greater than 92.7% at Nyquist frequency | Both horizontal and vertical MTFs are greater than 82.7% at Nyquist frequency |
| Pixel defects | - “Dot” corresponds to a sub-pixel; an entire pixel consists of three sub-pixels.
- “Bright Dot” and “Tiny Bright Dot” are distinguished by the brightness level, e.g., whether visible or not on the gray background whose DDL is equal to 96.
Defects are referred to as “Tiny Bright Dot” since the darker “Bright Dots” are mostly due to foreign material and the sizes tend to be smaller than those of the brighter “Bright Dots”.
- “Black Dot”: A dot recognized by human eyes as a black dot is counted as “Black Dot” regardless of the brightness and the size. | Maximum number allowed:
Bright Dots: 0
Tiny Bright Dots: 16
Black Dots: 15 | Maximum number allowed - Total: 5 |
| Artifacts | Visual artifacts including ringing, ghosting and image sticking were checked with the TG18 QC pattern | No visual artifacts were seen. | No visual artifacts were seen. |

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| Test | Test Method | Results | |
| --- | --- | --- | --- |
| | | MX317W-PA | MDPC-8127 |
| Temporal response | “Liquid Crystal Response Time (LCRT)” in the maximum luminance was measured. LCRT is standardized under International Committee for Display Metrology (ICDM) “Information Display Measurements Standard (IDMS)” Chapter 10.2. | Average: 17.6 ms
Gray to Gray: 19.2 ms
Maximum: 27.8 ms
Minimum: 9.9 ms
0→255→0: 25.5 ms | Average: 5.0 ms
Gray to Gray: 5.1 ms
Maximum:7.6 ms
Minimum: 3.1 ms
0→255→0: 10.1 ms |
| Maximum and minimum luminance | Maximum and minimum luminance were measured (cd/m²). | Achievable
-Max.: 547.5
-Min.: 0.289
Recommended
-Max.: 370.5
-Min.: 0.398
Targeted
-Max.: 370.0
-Min.: 0.40 | Achievable
-Max.: 678.6
-Min.: 0.633
Recommended
-Max.: 445.0
-Min.: 0.457
Targeted
-Max.: 450.0
-Min.: - |
| Grayscale | Measure the luminance of 18 DDLs at the screen center | Maximum Error Rate: 0.73% | Maximum Error Rate: 1.58% |
| Luminance uniformity and Mura test | The luminance non-uniformity was assessed in accordance with the following extract from the TG18 guideline. | DDL 204: 2.1% | DDL 204: 5.5% |
| Stability of luminance and chromaticity response | To evaluate the white (DDL=255) luminance stability over time | Deviation from target luminance (370 cd/m²): 0.79%
Variations for luminance and chromaticity: < 2.29% deviation | Deviation from target luminance (450 cd/m²): -2.66%
Variations for luminance and chromaticity: < 5.12% deviation |
| Reflection: Specular & Haze Components | The reflective property of the display screen was evaluated by measuring the specular reflection while varying the sizes of light source using the method proposed in “Effects of the Reflection Properties of Liquid-Crystal Displays on Subjective Ratings of Disturbing Reflected Glare” | 3°: 0.541
5°: 1.264
7°: 2.046
10°: 3.123
15°: 4.266 | 3°: 0.603
5°: 1.429
7°: 2.277
10°: 3.353
15°: 4.462 |

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| Test | Test Method | Results | |
| --- | --- | --- | --- |
| | | MX317W-PA | MDPC-8127 |
| | by Satoru KUBOTA et al. J. Lights & Vis. Env. Vol 21, No.1, 1997. | | |
| Reflection: Diffuse Reflection Coefficient | The diffuse reflection coefficient was measured in a dark-room environment using a sphere and a spectroradiometer | 0.0044 | 0.0060 |
| Gray tracking | The CIE xyY values of gray levels (0-255 DDLs) at the screen center measured | 0.00065 Δu’v’
White point at D65: 0.00038 Δu’v’ | 0.063 Δu’v’
White point at D65: 0.00076 Δu’v’ |
| Color scale | The color patches specified by the ISO standard were measured.
• ISO 12646: All combinations of 0, 63, 12, 191, 255/255 gradations for each of RGB + Gray 32, 98, 131, 157, 178, 196, 213, 228, 242/255 for a total of 134 patches.
• ISO 14861: 318 patches defined in Annex A. | 134 patches:
Ave.: 0.17 ΔE_{00}
Max.: 0.74 ΔE_{00}

138 patches:
Ave.: 0.20 ΔE_{00}
Max.: 0.86 ΔE_{00} | 134 patches:
Ave.: 0.41 ΔE_{00}
Max.: 1.36 ΔE_{00}

138 patches:
Ave.: 0.54 ΔE_{00}
Max.: 1.76 ΔE_{00} |
| Color gamut volume | The chromaticity at the center of the screen was measured to determine the coverage of the sRGB color gamut. | sRGB cover ratio: 99.2% | sRGB cover ratio: 99.0% |

VIII Proposed Labeling:

The labeling is sufficient, and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable, and the special controls for this device type, as applicable.

IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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