K Number
K190153
Device Name
RadiForce MX216
Manufacturer
Date Cleared
2019-03-08

(37 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
Device Description
RadiForce MX216 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 1,200 x 1,600 pixels (2MP) with a pixel pitch of 0.270 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. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce MX216 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 MX216.
More Information

Not Found

No
The summary describes a medical display monitor and associated quality control software. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on display characteristics and quality control.

No
Explanation: This device is a display monitor for viewing medical images and is intended for diagnosis, not for treating a disease or condition. Therefore, it is not a therapeutic device.

Yes

The device is indicated for displaying radiological images for "diagnosis by trained medical practitioners," and describes software (RadiCS) for "worry-free quality control of the diagnostic monitors."

No

The primary device described is a color LCD monitor (RadiForce MX216), which is a hardware device. While the submission includes software (RadiCS and RadiCS LE) as an accessory, the core device is hardware.

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

Here's why:

  • Intended Use: The intended use is to display radiological images for review, analysis, and diagnosis. This is related to medical imaging, not in vitro testing of biological samples.
  • Device Description: The device is a color LCD monitor designed for viewing medical images. It describes display technology, resolution, and calibration features, all related to image presentation.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any processes typically associated with in vitro diagnostics.

The device is clearly intended for the display of medical images generated by other diagnostic modalities (like X-ray, CT, MRI, etc.), which are then interpreted by medical practitioners. This falls under the category of medical imaging display devices, not in vitro diagnostics.

N/A

Intended Use / Indications for Use

This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

Product codes (comma separated list FDA assigned to the subject device)

PGY

Device Description

RadiForce MX216 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 1,200 x 1,600 pixels (2MP) with a pixel pitch of 0.270 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.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce MX216 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 MX216.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

The bench tests below were performed on the RadiForce MX216 following the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on October 2, 2017:

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

The test results showed that the RadiForce MX216 has display characteristics equivalent to those of the predicate device, RadiForce MX215.

Besides, the display characteristics of the RadiForce MX216 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce MX216.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K131090

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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

§ 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).

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

March 8, 2019

EIZO Corporation % Hiroaki Hashimoto Senior Manager 153 Shimokashiwano Hakusan, Ishikawano 924-8566 JAPAN

Re: K190153

Trade/Device Name: RadiForce MX216 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: January 28, 2019 Received: February 6, 2019

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 (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 located 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 vou, 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

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Hse 2. Nils

Thalia Mills, 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) K190153

Device Name RadiForce MX216

Indications for Use (Describe)

This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

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)☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ 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 Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov

"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."

3

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 a bold, sans-serif font on the right. The geometric shape is composed of squares and jagged edges, giving it a textured appearance. The "EIZO" text is followed by the registered trademark symbol.

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
Regulatory Compliance and
Safety |
|--------------------|----------------------------------------------------------|
| Telephone | +81 (76) 274-2468 |
| Fax | +81 (76) 274-2484 |
| E-Mail | hiroaki.hashimoto@eizo.com |

510(k) Summary

K190153

1. Submitter

EIZO Corporation 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Japan Phone: +81 (76) 274-2468 Fax: +81 (76) 274-2484

Contact Person: Hiroaki Hashimoto Date of Prepared: January 28th, 2019

2. Device

  • Name of Device: RadiForce MX216 ●
  • Common or Usual Name: 54.1 cm (21.3 inch) class Color LCD Monitor ●
  • Classification Name: Picture archiving and communications system . (21 CFR 892.2050)
  • Regulatory Class: II
  • . Product Code: PGY

3. Predicate Device

EIZO Corporation RadiForce MX215 (K131090)

4

4. Device Description

RadiForce MX216 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 1,200 x 1,600 pixels (2MP) with a pixel pitch of 0.270 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.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce MX216 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 MX216.

5. Indications for use

This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

5

6. Comparison of Technological Characteristics with the predicate device

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

| Attributes | Proposed Device:
RadiForce MX216 | Predicate Device:
RadiForce MX215 |
|---------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Display Technology | TFT Color
LCD Panel (IPS) | TFT Color
LCD Panel (IPS) |
| Screen size | 54cm / 21.3"
Aspect ratio: 3 : 4 | 54cm / 21.3"
Aspect ratio: 3 : 4 |
| Backlight type | LED | LED |
| Frame rate and refresh rate | | |
| Digital Scanning Frequency
(H / V) | 31 - 100 kHz / 59 - 61 Hz | 31 - 100 kHz / 59 - 61 Hz |
| Analog Scanning Frequency
(H / V) | - | 26 - 100 kHz / 49 - 76 Hz |
| Display Interface | | |
| Input video signals | DVI-D x 1,
DisplayPort x 1 | DVI-I x 1,
DisplayPort x 1 |
| Output video signals | DisplayPort x 1 (daisy chain) | - |
| Video bandwidth | | |
| | DVI : 164.5MHz
DisplayPort : 164.5MHz | DVI : 164.5MHz
DisplayPort : 164.5MHz
Analog : 164.5MHz |
| Ambient light sensing | | |
| Ambient light sensor | Yes | Yes |
| Luminance calibration tools | | |
| | Integrated optical sensor
External optical sensor
Calibration software:
RadiCS | Integrated optical sensor
External optical sensor
Calibration software:
RadiCS |
| Quality-control procedures | | |
| | Software: RadiCS | Software: RadiCS |

It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the MX216.

6

7. Performance Testing

The bench tests below were performed on the RadiForce MX216 following the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on October 2, 2017:

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

The test results showed that the RadiForce MX216 has display characteristics equivalent to those of the predicate device, RadiForce MX215.

Besides, the display characteristics of the RadiForce MX216 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce MX216.

8. Conclusion

The RadiForce MX216 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.