(269 days)
MDPC-8127 (K203364)
Not Found
No
The device description only mentions it being a color LCD monitor for viewing digital images, with no mention of any AI models, machine learning, or deep neural networks being part of its function.
No
The device is a monitor used for viewing images of histopathology slides, described as an aid to the pathologist for diagnosis, not a device that directly treats or prevents disease.
Yes
The device is described as "intended for in vitro diagnostic use to display digital images of histopathology slides... for the purposes of primary diagnosis," directly indicating its role in a diagnostic process.
No
The device description clearly identifies the RadiForce MX317W-PA as a "color LCD monitor," which is a piece of hardware.
Yes
The intended use statement explicitly states "RadiForce MX317W-PA is intended for in vitro diagnostic use".
N/A
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 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.
Product codes
PZZ
Device Description
RadiForce MX317W-PA is a color LCD monitor for viewing digital images of histopathology slides. The color LCD panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size is 4,096 x 2,160 pixels (8MP) with a pixel pitch of 0.1674 mm.
Since factory calibrated display modes, each of which is characterized by a specific tone curve, a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced.
"Patho" is for intended digital pathology use mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Pathologist / In vitro diagnostic use
Description of the training set, sample size, data source, and annotation protocol
No animal or clinical testing was performed on the RadiForce MX317W-PA.
Description of the test set, sample size, data source, and annotation protocol
No animal or clinical testing was performed on the RadiForce MX317W-PA.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were performed on the RadiForce MX317W-PA following the instructions in "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices" issued on April 20, 2016. The tests included:
- User controls: Modes and settings of the display undergoing testing.
- Spatial resolution
- Pixel defects
- Artifacts
- Temporal response
- Maximum and minimum luminance
- Grayscale
- Luminance uniformity and Mura test
- Stability of luminance and chromaticity response
- Bidirectional reflection distribution function
- Gray Tracking
- Color scale
- Color gamut volume
The test results showed that the RadiForce MX317W-PA has display characteristics equivalent to those of the predicate device, Barco MDPC-8127. Additionally, the display characteristics of the RadiForce MX317W-PA meet pre-defined criteria when criteria are set.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MDPC-8127 (K203364)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.3700 Whole slide imaging system.
(a)
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.(b)
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.
FDA 510(k) Clearance Letter for RadiForce MX317W-PA
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
May 23, 2025
EIZO Corporation
Hiroaki Hashimoto
Senior Manager of Regulatory Compliance and Safety Department
153 Shimokashiwano
Hakusan, Ishikawa 924-8566
Japan
Re: K242545
Trade/Device Name: RadiForce MX317W-PA
Regulation Number: 21 CFR 864.3700
Regulation Name: Whole slide imaging system
Regulatory Class: Class II
Product Code: PZZ
Dated: August 27, 2024
Received: August 27, 2024
Dear Hiroaki 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Page 3
Sincerely,
Shyam Kalavar -S
Shyam Kalavar
Deputy Branch Chief
Division of Molecular Genetics and Pathology
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K242545
Device Name: RadiForce MX317W-PA
Indications for Use (Describe):
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.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
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PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(k) Summary
K242545
1. Submitter
EIZO Corporation
153 Shimokashiwano, Hakusan,
Ishikawa 924-8566 Japan
Phone: +81 (76) 274-2468
Contact Person: Hiroaki Hashimoto
Date of Prepared: May 19, 2025
2. Device
- Name of Device: RadiForce MX317W-PA
- Common or Usual Name: 30.5 inch (77.5 cm) Color LCD Monitor
- Classification Name: Whole Slide Imaging System (21 CFR 864.3700)
- Regulatory Class: II
- Product Code: PZZ
3. Predicate Device
- Name of Device: MDPC-8127 (K203364)
- Common or Usual Name: Digital Pathology Display
- Classification Name: Whole Slide Imaging System (21 CFR 864.3700)
- Regulatory Class: II
- Product Code: PZZ
Page 6
4. Device Description
RadiForce MX317W-PA is a color LCD monitor for viewing digital images of histopathology slides. The color LCD panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size is 4,096 x 2,160 pixels (8MP) with a pixel pitch of 0.1674 mm.
Since factory calibrated display modes, each of which is characterized by a specific tone curve, a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced.
"Patho" is for intended digital pathology use mode.
5. 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 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.
Page 7
6. Comparison of Technological Characteristics with the predicate device
The comparison table below enumerates information derived from the product brochure and measured values of each device and different technological characteristics are discussed in it:
| Attributes | Proposed Device: RadiForce MX317W-PA | Predicate Device: Barco MDPC-8127 |
|---|---|---|
| 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 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. | 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 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. |
| Technological characteristics of the display device | ||
| LCD Panel | TFT Color LCD Panel (IPS) | IPS |
| Physical size of the viewable area and aspect ratio | 77.5cm / 30.5" Aspect ratio: 17 : 9 | 68.4cm / 27" Aspect ratio: 16 : 9 |
| Backlight type and properties including temporal, spatial, and spectral characteristics | LED | LED |
| Frame rate | 60 Hz | 120Hz |
| Pixel pitch | 0.1674 mm x 0.1674 mm | 0.155 mm |
| Subpixel pattern | RGB Vertical Stripe | RBG vertical stripe |
| Pixel aperture ratio | 0.571 | 0.502 |
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| Subpixel driving to improve grayscale resolution (e.g., spatial and temporal dithering) | ||
|---|---|---|
| Independent Subpixel drive | OFF | OFF |
| Dithering | LCD Specification: True 10bit 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 | DisplayPort x 2 |
| Output video signals | USB Type-C (daisy chain) x 1 | None |
| 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 | Yes |
| Touch screen technology including method, functionality, and any calibration or periodical retuning requirements | ||
| N/A | N/A | |
| Color calibration tools (sensor hardware and associated software), color profile, and method for color management | ||
| Integrated optical sensor External optical sensor Calibration software: RadiCS | Front sensor: I-Guard Calibration software: QAWeb Enterprise | |
| Frequency and nature of quality-control tests to be performed by the user and/or the physicist with associated action limits | ||
| Software: RadiCS AAPM On-line Report No. 03:2005 compliant | Software: QAWeb Enterprise |
The technological characteristics differences discussed above do not affect the safety and the effectiveness of the MX317W-PA.
Page 9
7. Performance Testing
The bench tests below were performed on the RadiForce MX317W-PA following the instructions in "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices" issued on April 20, 2016:
- User controls: Modes and settings of the display undergoing testing.
- Spatial resolution
- Pixel defects
- Artifacts
- Temporal response
- Maximum and minimum luminance
- Grayscale
- Luminance uniformity and Mura test
- Stability of luminance and chromaticity response
- Bidirectional reflection distribution function
- Gray Tracking
- Color scale
- Color gamut volume
The test results showed that the RadiForce MX317W-PA has display characteristics equivalent to those of the predicate device, Barco MDPC-8127.
Besides, the display characteristics of the RadiForce MX317W-PA meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce MX317W-PA.
8. Conclusion
The RadiForce MX317W-PA 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 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.