(126 days)
No
The description focuses on the hardware (monitor) and basic software for quality control, with no mention of AI/ML capabilities for image analysis or processing.
No
The device is a medical image display for review, analysis, and diagnosis, not for treatment.
Yes
The intended use explicitly states the product is "indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners." The device also undergoes performance tests relevant to diagnostic display standards.
No
The device description clearly states that the primary device is a color LCD monitor (RadiForce RX270) with specific hardware characteristics (IPS technology, resolution, pixel pitch, surface treatment). While it includes accessory software (RadiCS), the core device being submitted is a hardware display.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is clearly stated as "displaying radiological images for review, analysis, and diagnosis by trained medical practitioners." This involves the visualization of images generated from within the body, not the analysis of samples taken from the body (which is the core of IVD).
- Device Description: The device is described as a "color LCD monitor for viewing medical images." This is a display device, not a device that performs tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
The device is a medical image display monitor used for diagnostic purposes, but it falls under the category of medical devices for image display and analysis, not IVDs.
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 RX270 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.
There are two model variations. RX270 and RX270-AR. The difference of the two variations is the surface treatment of the RX270 is Anti-Glare (AG) treatment and that of the RX270-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 RX270 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 RX270.
RadiCS is of Minor level of concern and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce RX270 and it's not a medical imaging software.
Mentions image processing
Yes
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 RX270 following the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on September 28,2022:
- 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 RX270 has display characteristics equivalent to those of the predicate device, RadiForce RX250.
Besides, the display characteristics of the RadiForce RX270 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce RX270.
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.
RadiForce RX250, RX250-AR (K160247), RadiForce RX360, RX360-AR (K182591)
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.
RadiForce MX216: K190153, RadiForce RX350: K153354, RadiForce RX660: K163335
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.
EIZO Corporation % Hiroaki Hashimoto Senior Manager 153 Shimokashiwano Hakusan, Ishikawa 924-8566 Japan
April 20, 2023
Re: K223768
Trade/Device Name: RadiForce RX270 and RX270-AR Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: January 25, 2023 Received: January 30, 2023
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 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
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/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,
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223768
Device Name RadiForce RX270, RX270-AR
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)
| Recreational (Day Use Only, Subject to Closure) | Overnight Camping (Not Subject to Closure) |
|---|---|
| -------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------- |
X 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.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."
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 bold, sans-serif font on the right. The geometric shape is a square with a checkered pattern and jagged edges. The "R" in a circle is located to the right of the letter "O".
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
| Name | Hiroaki Hashimoto |
|---|---|
| Department | Regulatory Compliance and |
| Safety | |
| Telephone | +81 (76) 274-2468 |
| hiroaki.hashimoto@eizo.com |
510(k) Summary K223768
1. Submitter
EIZO Corporation 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Japan Phone: +81 (76) 274-2468
Contact Person: Hiroaki Hashimoto Date of Prepared: December 9th, 2022
2. Device
- Name of Device: RadiForce RX270, RX270-AR
- Common or Usual Name: 21.3 inch (54.0 cm) Color LCD Monitor
- Classification Name: Medical image management and processing system ● (21 CFR 892.2050)
- Regulatory Class: ● II
- Product Code: PGY ●
3. Predicate Device
- Name of Device: RadiForce RX250, RX250-AR (K160247) ●
- Common or Usual Name: 2MP Color LCD Monitor ●
- Classification Name: Medical image management and processing system ● (21 CFR 892.2050)
- Regulatory Class: II
- . Product Code: PGY
- RadiForce RX360, RX360-AR (K182591) ● Name of Device:
- 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 ●
4
4. Device Description
RadiForce RX270 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.
There are two model variations. RX270 and RX270-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX270 is Anti-Glare (AG) treatment and that of the RX270-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 RX270 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 RX270.
RadiCS is of Minor level of concern and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce RX270 and it's not a medical imaging software.
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 and measured values of the each device and different technological characteristics are discussed in it:
| Attributes | Proposed Device:
RadiForce RX270 | Predicate Device:
RadiForce RX250 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. |
| Display Technology | TFT Color LCD Panel (IPS) | TFT Color LCD Panel (IPS) |
| Screen size | 54.0cm / 21.3"
Aspect ratio: 3 : 4 | 54.0cm / 21.3"
Aspect ratio: 3 : 4 |
| Backlight type | LED | LED |
| Frame rate and refresh rate | 31 - 100 kHz / 59 - 61 Hz
(VGA TEXT: 69 - 71 Hz)
Frame synchronous mode: 59 - 61
Hz | 31 - 100 kHz / 59 – 61 Hz (VGA
Text: 69-71 Hz)
Frame synchronous mode: 59 - 61
Hz |
| Display Interface | | |
| Input video signals | DVI-D x 1,
DisplayPort x 2 | DVI-D x 1,
DisplayPort x 1 |
| Output video signals | DisplayPort x 1 (daisy chain) | DisplayPort x 1 (daisy chain) |
| Video bandwidth | | |
| | DVI : 25 - 164.5MHz
DisplayPort : 25 - 164.5MHz | DVI : 25 - 164.5MHz
DisplayPort : 25 - 164.5MHz |
| Ambient light sensing | | |
| Ambient light sensor | Photo Diode Position: In the upper
bezel of the screen
Software tool: RadiCS | Photo Diode Position: In the upper
bezel of the screen
Software tool: RadiCS |
| Luminance calibration tools | | |
| | Integrated optical sensor
External optical sensor | Integrated optical sensor
External optical sensor |
| Quality-control procedures | | |
| | Software: RadiCS | Software: RadiCS |
| New functions | | |
| Hybrid Gamma PXL | This function is implemented on the
510(k) cleared RadiForce MX216:
K190153 or later.
This function is user selectable and
default: off.
Even turn on, this function does not
affect monochrome images. | - |
| LEA (Life
Expectancy
Analyzer) | This function is implemented on the
510(k) cleared RadiForce RX350:
K153354 or later.
This function is to calculate the
product life and it does not affect
images. | - |
| USB Selection for
KVM Switch | This function is implemented on the
510(k) cleared RadiForce RX660:
K163335 or later.
This function is a USB switching
function and it does not affect
images. | - |
6
It is clear that the technological characteristics differences discussed above are substantially equivalent and new functions do not affect the safety and the effectiveness of the RX270.
7
7. Performance Testing
The bench tests below were performed on the RadiForce RX270 following the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on September 28,2022:
- . 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 RX270 has display characteristics equivalent to those of the predicate device, RadiForce RX250.
Besides, the display characteristics of the RadiForce RX270 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce RX270.
8. Conclusion
The RadiForce RX270 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.