(55 days)
Not Found
No
The document describes a medical display monitor and associated quality control software. There is no mention of AI or ML capabilities in the device description, intended use, or performance studies. The software is described as basic documentation level and not medical imaging software.
No
This device is a display monitor for viewing radiological images for diagnosis, not a device used for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product is "indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners."
No
The device description clearly states that the primary device is a color LCD monitor (RadiForce RX670), which is a hardware component. While the submission includes accessory software (RadiCS), the core device is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
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 describes a device used for viewing and interpreting medical images, which falls under the category of medical imaging devices, not IVDs.
- Device Description: The description details a color LCD monitor designed for viewing medical images. It focuses on display characteristics, resolution, tone curves, and quality control software. This aligns with the description of a medical display device.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided text does not mention any interaction with biological samples or performing diagnostic tests on them.
- Focus on Image Display: The entire document revolves around the technical specifications and performance of a display device for medical images.
Therefore, the RadiForce RX670 is a medical 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 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 RX670 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 3,280 x 2,048 pixels (6MP) with a pixel pitch of 0.1986 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. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced.
There are two model variations. RX670 and RX670-AR. The difference of the two variations is the surface treatment of the RX670 is Anti-Glare (AG) treatment and that of the RX670-AR is Anti-Reflection (AR) coating.
RadiCS is application software to be installed in each workstation offering worry-free quality control of diagnostic monitors including the RadiForce RX670 based on the QC standards and guidelines capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce RX670.
RadiCS is Basic Documentation level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce RX670 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 were performed on the RadiForce RX670 following the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on September 28, 2022. The tests included:
- 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 RX670 has display characteristics equivalent to those of the predicate device, RadiForce RX660. Besides, the display characteristics of the RadiForce RX670 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce RX670.
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 RX660, RX660-AR (K163335), RadiForce RS340 (K143098)
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
EIZO Corporation Hiroaki Hashimoto Senior Manager of Regulatory Compliance and Safety Department 153 Shimokashiwano HAKUSAN, ISHIKAWA, 924-8566 JAPAN
July 16, 2024
Re: K241441
Trade/Device Name: RadiForce RX670; RadiForce RX670-AR Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: May 22, 2024 Received: May 22, 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" (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).
1
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); medical device 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-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 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.
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-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 Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
RadiForce RX670;
RadiForce RX670-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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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
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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 "®" symbol is located to the upper right of the letter "O" in "EIZO".
| EIZO Corporation, 153 Shimokashiwano, Hakusan, Ishikawa
924-8566 Japan | Name
Department | Hiroaki Hashimoto
Regulatory Compliance and
Safety |
|---------------------------------------------------------------------------------|--------------------|----------------------------------------------------------|
| U.S. Food and Drug Administration
Center for Devices and Radiological Health | Telephone | +81 (76) 274-2468 |
| | E-Mail | hiroaki.hashimoto@eizo.com |
510(k) Summary K241441
1. Submitter
EIZO Corporation 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Japan Phone: +81 (76) 274-2468 Contact Person: Hiroaki Hashimoto Date of Prepared: May 20th, 2024
2. Device
- Name of Device: RadiForce RX670; RadiForce RX670-AR
- Common or Usual Name: 30.0 inch (76.2 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 RX660, RX660-AR (K163335)
- Common or Usual Name: 6MP Color LCD Monitor ●
- Classification Name: Medical Image Management and Processing System ● (21 CFR 892.2050)
- Regulatory Class: II
- Product Code: PGY
- Name of Device: RadiForce RS340 (K143098) ●
- Common or Usual Name: 3MP Color LCD Monitor ●
- Classification Name: Medical Image Management and Processing System ● (21 CFR 892.2050) ● Regulatory Class: II
- Product Code: PGY
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4. Device Description
RadiForce RX670 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 3,280 x 2,048 pixels (6MP) with a pixel pitch of 0.1986 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. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced.
There are two model variations. RX670 and RX670-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX670 is Anti-Glare (AG) treatment and that of the RX670-AR is Anti-Reflection (AR) coating.
RadiCS is application software to be installed in each workstation offering worry-free quality control of diagnostic monitors including the RadiForce RX670 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce RX670.
RadiCS is Basic Documentation level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce RX670 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 RX670 | Predicate Device:
RadiForce RX660 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | 76.2cm / 30.0"
Aspect ratio: 16 : 10 | 76.0cm / 30.0"
Aspect ratio: 16 : 10 |
| Backlight type | LED | LED |
| Frame rate and refresh rate | | |
| Digital Scanning Frequency
(H / V) | 31 - 127 kHz /
VGA TEXT: 69 - 71Hz, Except
VGA TEXT:59 - 61Hz,
Frame synchronous mode: 59 - 61
Hz | 31 - 127 kHz / 22 - 61Hz (DVI),
29 - 61Hz (DisplayPort), VGA
TEXT: 69 - 71Hz (DVI,
DisplayPort)
Frame synchronous mode: 29.5 –
30.5 Hz, 59 - 61 Hz |
| Display Interface | | |
| Input video
signals | USB Type-C (DisplayPort Alt
Mode) x 1,
DisplayPort x 2,
HDMI x 1 | DVI-D (dual link) x 1,
DisplayPort x 2 |
| Output video
signals | USB Type-C (daisy chain) x 1 | DisplayPort x 1 (daisy chain) |
| Video bandwidth | (HDMI)
25-440MHz
(DisplayPort)
25-440MHz
(DisplayPort Alt Mode Input(on
USB Type-C)) | (DVI)
Single Display:
Except LM derivation: 25-
240MHz
LM derivation: 25-280MHz
Up to 165MHz: Single Link
Over 165MHz: Dual Link |
| | 25-440MHz | Up to 165MHz: Single Link
Over 165MHz: Dual Link |
| | | (DisplayPort)
DP1 Port Single Display: 25-
440MHz
PbyP/PinP: 25-240MHz
DP2 Port: 25-240MHz |
| Ambient light sensing | | |
| Ambient light sensor | Photo Diode
Position: In the upper bezel of the
screen | Photo Diode
Position: In the upper bezel of the
screen |
| | Software tool: RadiCS | Software tool: RadiCS |
| 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 |
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It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the RX670.
7
7. Performance Testing
The bench tests below were performed on the RadiForce RX670 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 RX670 has display characteristics equivalent to those of the predicate device, RadiForce RX660.
Besides, the display characteristics of the RadiForce RX670 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce RX670.
8. Conclusion
The RadiForce RX670 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.