(28 days)
No
The 510(k) summary describes a medical display monitor and associated quality control software. There is no mention of AI or ML capabilities for image analysis, processing, or diagnosis. The focus is on display characteristics and quality control.
No.
The device's intended use is for displaying radiological images for review, analysis, and diagnosis, which makes it a diagnostic device, not a therapeutic one. It does not actively treat a condition.
Yes
The "Intended Use / Indications for Use" states that the product is "indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners." The term "diagnosis" clearly indicates its use as a diagnostic device.
No
The device description clearly states that the primary device is a color LCD monitor (RadiForce RX360), which is a hardware component. While it includes accessory software (RadiCS), the core device being cleared is the monitor itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "displaying radiological images for review, analysis, and diagnosis by trained medical practitioners." This involves the visualization of medical images, not the examination of specimens derived from the human body.
- Device Description: The device is 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: The description does not mention any components or functions related to collecting, preparing, or analyzing biological specimens (like blood, urine, tissue, etc.).
IVD devices are specifically designed to perform tests on specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to display images generated by other medical devices (like X-ray machines, CT scanners, etc.).
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
PGY
Device Description
RadiForce RX360 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 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.2115 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, RX360 and RX360-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX360 is Anti-Glare (AG) treatment and that of the RX360-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 RX360 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 RX360.
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
The bench tests below were performed on the RadiForce RX360 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 RX360 has display characteristics equivalent to those of the predicate device. RadiForce RX350.
Besides, the display characteristics of the RadiForce RX360 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce RX360.
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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October 18, 2018
EIZO Corporation Hiroaki Hashimoto Senior Manager 153 Shimokashiwano HAKUSAN, 924-8566 JAPAN
Re: K182591
Trade/Device Name: RadiForce RX360, RX360-AR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: PGY Dated: September 14, 2018 Received: September 20, 2018
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 mav, 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 avare 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
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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.
Michael D. O'Hara For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182591
Device Name RadiForce RX360, RX360-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) | X |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 | Hiroaki Hashimoto |
|---|---|
| Department | Regulatory Compliance and |
| Safety | |
| Telephone | +81 (76) 274-2468 |
| Fax | +81 (76) 274-2484 |
| hiroaki.hashimoto@eizo.com |
510(k) Summary
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: September 14th, 2018
2. Device
●
- Name of Device: RadiForce RX360, RX360-AR
- 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 RX350 (K153354)
4
4. Device Description
RadiForce RX360 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 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.2115 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, RX360 and RX360-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX360 is Anti-Glare (AG) treatment and that of the RX360-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 RX360 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 RX360.
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 RX360 | Predicate Device:
RadiForce RX350 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Display Technology | Color (IPS) | Color (IPS) |
| Screen size | 54.1cm / 21.3"
Aspect ratio: 3 : 4 | 54.1cm / 21.3"
Aspect ratio: 3 : 4 |
| Backlight type | LED | LED |
| Frame rate and refresh rate | 31 - 127 kHz / 29 - 61.5 Hz
(VGA Text: 69 - 71 Hz)
Frame synchronous mode: 29.5
- 30.5 Hz, 59 - 61 Hz | 31 - 127 kHz / 29 - 61.5 Hz
(VGA Text: 69 - 71 Hz)
Frame synchronous mode: 29.5 - 30.5 Hz, 59 - 61 Hz |
| Display Interface | | |
| Input video
signals | DVI-D (dual link) x 1,
DisplayPort x 2 | DVI-D (dual link) x 1,
DisplayPort x 1 |
| Output video
signals | DisplayPort x 1 (daisy chain) | DisplayPort x 1 (daisy chain) |
| Video bandwidth | DVI : 215MHz
DisplayPort : 215MHz | DVI : 215MHz
DisplayPort : 215MHz |
| 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
AAPM On-line Report
No.
03:2005 compliant | Software: RadiCS
AAPM On-line
Report
No.
03:2005 compliant |
It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the RX360.
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7. Performance Testing
The bench tests below were performed on the RadiForce RX360 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 RX360 has display characteristics equivalent to those of the predicate device. RadiForce RX350.
Besides, the display characteristics of the RadiForce RX360 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce RX360.
8. Conclusion
The RadiForce RX360 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.