(25 days)
No
The device description and performance studies focus on the technical specifications and display characteristics of a medical monitor, with no mention of AI or ML for image analysis or interpretation.
No
The device is a color LCD monitor used for displaying radiological images for review, analysis, and diagnosis, which are diagnostic functions, not therapeutic.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the product is indicated for "review, analysis, and diagnosis" of radiological images by trained medical practitioners. This directly aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "color LCD monitor" and details its physical characteristics (resolution, pixel pitch, surface treatment). While it includes software (RadiCS), the primary device being submitted is hardware.
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 description clearly states that this device is a color LCD monitor used for displaying radiological images. It is a tool for viewing and interpreting medical images, not for performing tests on biological samples.
- Intended Use: The intended use is for "displaying radiological images... for review, analysis, and diagnosis by trained medical practitioners." This aligns with the function of a medical image display, not an IVD.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, sample handling, or analysis of biological specimens, which are all hallmarks of an IVD.
Therefore, the RadiForce RX1270 is a medical image display device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This product is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
Product codes
PGY
Device Description
RadiForce RX1270 is a color LCD monitor for viewing medical images including those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 4.200 x 2.800 pixels (12MP) with a pixel pitch of 0.1554 mm. With the matrix size (or resolution) of 4.200 x 2.800 pixels (12MP), the RX1270 is an optimal replacement for traditional dual head 2,048 x 2,560 pixels (5MP) display installations. 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. There are two model variations, RX1270 and RX1270-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX1270 is Anti-Glare (AG) treatment and that of the RX1270-AR is Anti-Reflection (AR) coating. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX1270 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 RX1270.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiological images (including full-field digital mammography and digital breast tomosynthesis)
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 bench tests below were performed on the RadiForce RX1270 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 the angular dependency of luminance response in horizontal, vertical and diagonal directions
- 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
- Performance data on luminance stability
- Measurement of noise expressed as noise power spectrum (NPS)
- Measurement of display reflections including specular, diffuse and haze components
- Measurement of small-spot contrast ratio
- Measurement of pixel aperture ratio
- Measurement of Color tracking and Gray tracking
The test results showed that the RadiForce RX1270 has display characteristics equivalent to those of the predicate device, RadiForce RX560.
Besides, the display characteristics of the RadiForce RX1270 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce RX1270.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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March 23, 2020
EIZO Corporation % Mr. Hiroaki Hashimoto Senior Manager of Regulatory Compliance and Safety Department 153 Shimokashiwano, Hakusan Ishikawa 924-8566 JAPAN
Re: K200485
Trade/Device Name: RadiForce RX1270, RadiForce RX1270-AR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: February 25, 2020 Received: February 27, 2020
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. 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 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200485
Device Name RadiForce RX1270, RadiForce RX1270-AR
Indications for Use (Describe)
This product is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
| 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) |
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3
Image /page/3/Picture/0 description: The image shows the logo for EIZO. The logo consists of a stylized square made up of smaller squares, next to the company name "EIZO" in bold, sans-serif font. A registered trademark symbol is located to the right of the company name. The logo is in black and white.
EIZO Corporation, 153 Shimokashiwano, Hakusan, Ishikawa 071-2566 Isnan
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 Fax E-Mail
+81 (76) 274-2468 +81 (76) 274-2484 hiroaki.hashimoto@eizo.com
510(k) Summary K200485
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: February 25th, 2020
2. Device
| • Name of Device: | RadiForce RX1270,
RadiForce RX1270-AR |
|-------------------------|------------------------------------------------------------------|
| • Common or Usual Name: | 78.4 cm (30.9 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
| • | 510(k) Holder: | EIZO Corporation |
|---|---|---|
| --- | ---------------- | ------------------ |
- 510(k) Number: K172738
- Name of Device: RadiForce RX560, RX560-AR ●
II
- 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:
- PGY ● Product Code:
4
4. Device Description
RadiForce RX1270 is a color LCD monitor for viewing medical images including those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 4.200 x 2.800 pixels (12MP) with a pixel pitch of 0.1554 mm. With the matrix size (or resolution) of 4.200 x 2.800 pixels (12MP), the RX1270 is an optimal replacement for traditional dual head 2,048 x 2,560 pixels (5MP) display installations.
Image /page/4/Picture/2 description: The image shows two medical monitors displaying different types of medical scans. The monitor on the left displays a series of CT scans of the chest and lungs, including cross-sectional views and 3D reconstructions. The monitor on the right shows a mammogram on the left screen and ultrasound images of the breast on the right screen. The images suggest the use of advanced medical imaging technologies for diagnostic purposes.
RX1270 (12MP)
RX560 (5MP) x 2
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.
There are two model variations, RX1270 and RX1270-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX1270 is Anti-Glare (AG) treatment and that of the RX1270-AR is Anti-Reflection (AR) coating.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX1270 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 RX1270.
5
5. Indications for use
The stated intended use of the two devices is substantially the same:
● RadiForce RX1270
This product is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
● RadiForce RX560
This product is intended to be used in displaying and viewing digital images, including standard and multiframe digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
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6. Comparison of Technological Characteristics with the predicate device
The comparison table below enumerates information derived from the product brochure and measured values of the each device and different technological characteristics are discussed in it:
| Attributes | Proposed Device:
RadiForce RX1270 | Predicate Device:
RadiForce RX560 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Display Technology | TFT Color
LCD Panel (IPS) | TFT Color
LCD Panel (IPS) |
| Screen size | 78.4cm / 30.9" | 54.1cm / 21.3" |
| Resolution | 4200 x 2800 (3:2 aspect ratio) | 2048 x 2560 (4:5 aspect ratio) |
| Pixel pitch | 0.1554 x 0.1554 mm | 0.165 x 0.165 mm |
| Backlight type | LED | LED |
| Maximum luminance | 1200 cd/m² | 1100 cd/m² |
| DICOM calibrated luminance | 500 cd/m² | 500 cd/m² |
| Contrast Ratio (typical) | 1500:1 | 1500:1 |
| Response Time (typical) | 12 ms (black-white-black) | 12 ms (black-white-black) |
| Frame rate and refresh rate | | |
| Digital Scanning Frequency
(H / V) | HDMI: 31 - 160 kHz / 59 - 61 Hz
(VGA Text: 69 - 71 Hz)
DisplayPort: 31 - 175 kHz / 29 -
61 Hz
(VGA Text: 69 - 71 Hz)
Frame synchronous mode:
29.5 - 30.5 Hz, 59 - 61 Hz | 31 - 135 kHz / 23 - 61 Hz
Frame synchronous mode: 23.5 -
25.5 Hz, 47 - 51 Hz |
| Analog Scanning Frequency
(H / V) | HDMI: 31 - 160 kHz / 59 - 61 Hz
(VGA Text: 69 - 71 Hz)
DisplayPort: 31 - 175 kHz / 29 -
61 Hz
(VGA Text: 69 - 71 Hz)
Frame synchronous mode:
29.5 - 30.5 Hz, 59 - 61 Hz | 31 - 135 kHz / 23 - 61 Hz
Frame synchronous mode: 23.5 -
25.5 Hz, 47 - 51 Hz |
| Input video signals | DisplayPort x 2,
HDMI | DVI-D (dual link) x 1,
DisplayPort x 1 |
| Output video signals | - | DisplayPort x 1 (daisy chain) |
| Video bandwidth | | |
| | HDMI: 260MHz
DisplayPort: 765MHz | DVI: 290MHz
DisplayPort: 290MHz |
| 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 |
7
It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the RX1270.
8
7. Performance Testing
The bench tests below were performed on the RadiForce RX1270 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 the angular dependency of luminance response in horizontal, vertical and diagonal directions
- . 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
- . Performance data on luminance stability
- Measurement of noise expressed as noise power spectrum (NPS)
- Measurement of display reflections including specular, diffuse and haze components ●
- . Measurement of small-spot contrast ratio
- Measurement of pixel aperture ratio ●
- Measurement of Color tracking and Gray tracking
The test results showed that the RadiForce RX1270 has display characteristics equivalent to those of the predicate device, RadiForce RX560.
Besides, the display characteristics of the RadiForce RX1270 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce RX1270.
9
8. Conclusion
The RadiForce RX1270 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.