(27 days)
Not Found
No
The device is a medical display monitor and associated quality control software. The description focuses on display technology, calibration, and quality control, with no mention of AI or ML capabilities for image analysis or processing.
No.
The device is a medical display monitor for viewing diagnostic images, not a device that directly treats or diagnoses a disease/condition.
No
The device is a monitor used for displaying images for review, analysis, and diagnosis, but it does not perform the diagnosis itself. Its function is to facilitate the diagnostic process for medical practitioners.
No
The primary device described is a color LCD monitor (RadiForce MX315W), which is a hardware component. While software (RadiCS) is included 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 "displaying digital images for review, analysis and diagnosis by trained medical practitioners." This describes a device used for viewing and interpreting medical images, which is a function of medical imaging devices, not IVDs.
- Device Description: The device is described as a "color LCD monitor for viewing medical images." This further reinforces its role as a display device for medical images.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not interact with biological specimens or perform any analysis on them.
- Performance Studies: The performance studies focus on display characteristics (DICOM conformance, luminance, chromaticity, spatial resolution, pixel defects), which are relevant to the quality of image display, not the performance of an in vitro diagnostic test.
Therefore, the RadiForce MX315W is a medical image display device, not an IVD.
N/A
Intended Use / Indications for Use
This product is intended to be used in displaying digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Product codes
PGY
Device Description
RadiForce MX315W 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 4,096 x 2,160 pixels (8MP) with a pixel pitch of 0.1704 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 MX315W 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 MX315W.
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 following bench tests were performed on the RadiForce MX315W.
- 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 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
- . Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance
- Visual check of presence or absence of miscellaneous artifacts on the display screen . as specified in TG18 guideline
- . Measurement of spatial resolution expressed as modulation transfer function (MTF)
- The maximum number allowed for each type of pixel defects/faults ●
The test results showed that the RadiForce MX315W has display characteristics equivalent to those of the predicate device, RadiForce RX840.
Besides, the display characteristics of the RadiForce MX315W meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce MX315W.
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).
0
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three overlapping profiles of human faces, oriented to the right. The profiles are depicted in a minimalist style, with flowing lines suggesting hair and facial features.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 27, 2017
EIZO Corporation Hiroaki Hashimoto Manager Medical System Standards 153 Shimokashiwano. Hakusan Ishikawa 924-8566 JAPAN
Re: K170949
Trade/Device Name: RadiForce MX315W Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: PGY Dated: March 27, 2017 Received: March 31, 2017
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. 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Robert Oals
Robert Ochs, 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)
Device Name RadiForce MX315W
Indications for Use (Describe)
This product is intended to be used in displaying digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Type of Use (Select one or both, as applicable)
X 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, geometric shape on the left and the word "EIZO" in bold, sans-serif font on the right. The geometric shape is a square divided into smaller squares, some of which are shaded to create a checkered pattern. The "EIZO" text is in black, and there is a small "®" symbol next to the "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 Department
Hiroaki Hashimoto Medical System Standards
Telephone Fax E-Mail
+81 (76) 274-2468 +81 (76) 274-2484 hiroaki.hashimoto@eizo.com
510(k) Summary (in accordance with 21 CFR 807.92)
1. Company
EIZO Corporation 153 Shimokashiwano, Hakusan Ishikawa 924-8566 Japan Tel: +81 (76) 274-2468 Fax: +81 (76) 274-2484
2. Contact Person
Hiroaki Hashimoto
-
- Date of Summary March 27th, 2017
4. Device Information
- RadiForce MX315W Device Name: .
- Trade Name/Model: RadiForce MX315W
- Common Name: 79.0 cm (31.1 inch) class Color LCD Monitor ●
- Classification Name: ● Display, Diagnostic Radiology
- Regulation Number: ● 21 CFR 892.2050, Product Code PGY
5. Predicate Device
8MP Color LCD Monitor, RadiForce RX840 (K113226)
4
6. Device Description
RadiForce MX315W 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 4,096 x 2,160 pixels (8MP) with a pixel pitch of 0.1704 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 MX315W 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 MX315W.
7. Indications for use
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.
5
8. Comparison of Technological Characteristics
The comparison table below enumerates information derived from the product brochure of the each device and different technological characteristics are discussed in it:
| Attributes | RadiForce MX315W | RadiForce RX840 | Explanation of
Differences | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Display Performance/Specifications | | | | |
| Screen
technology | TFT Color
LCD Panel (IPS) | TFT Color
LCD Panel (IPS) | | |
| Viewing angle
(H, V) | H: 178°, V: 178° | H: 176°, V: 176° | - | |
| Resolution | 8MP (4,096 x 2,160) | 8MP (4,096 x 2,160) | | |
| Aspect ratio | 17 : 9 | 17 : 9 | | |
| Active screen
size | 697.9 mm x 368.0 mm | 817.1 mm x 430.9 mm | | |
| Pixel pitch | 0.1704 mm x 0.1704 mm | 0.1995 mm x 0.1995 mm | | |
| Maximum
luminance | 450 cd/m² | 700cd/m² | Both devices'
Maximum and | |
| DICOM
calibrated
luminance | 270 cd/m² | 400 cd/m2 | DICOM calibrated
luminance are greater
than 171cd/m2 which
is required for
primary displays in
AAPM On-line
Report No. 03:2005
(Sec. 4.3.4.2.1) with
enough margin. | |
| Contrast ratio | 1300 : 1 | 1000: 1 | | |
| Response
Time (typical) | 20 ms (On/Off) | 25 ms (On/Off) | | |
| Backlighting | LED | LED | | |
| Display Colors | 10-bit colors
(DisplayPort) : 1.07 billion
(maximum) colors
8-bit colors: 16.77 million
from a palette of 68 billion
colors | 10-bit colors
(DisplayPort) : 1.07 billion
(maximum) colors
8-bit colors: 16.77 million
from a palette of 68 billion
colors | | |
| Luminance
non-
uniformity
compensation | Digital Uniformity
Equalizer | Digital Uniformity
Equalizer | | |
| Video Signals | | | | |
| Input video
signals | DVI-D (dual link) x 1,
DisplayPort x 2 | DVI-D (dual link) x 2,
DisplayPort x 2 | | |
6
| Output video signals | DisplayPort x 1 (daisy chain) | - |
|---|---|---|
| Scanning Frequency (H, V) | 31 - 134 kHz / 14 - 61 Hz, | |
| (VGA Text: 69 - 71 Hz) | ||
| Frame synchronous mode: | ||
| 29.5 - 30.5 Hz, 59 - 61 Hz | 31 - 140 kHz / 29.5 - 30.5 Hz (2048 x 2160, 1920 x 2160), | |
| 59 - 61 Hz, (VGA Text: 69 - 71 Hz) | ||
| Frame synchronous mode: | ||
| 29.5 - 30.5 Hz, 59 - 61 Hz | ||
| Power Related Specifications | ||
| Power Requirements | AC 100 - 240 V: | |
| 50 / 60 Hz | AC 100 - 120 V, | |
| 200 - 240 V: 50 / 60 Hz | ||
| Power Consumption / Save Mode | 125 W / Less than 1.6 W | 350 W / Less than 6 W |
| Power Management | DVI DMPM, | |
| DisplayPort 1.2a | DVI DMPM, | |
| DisplayPort 1.1a | ||
| Miscellaneous Features/Specifications | ||
| QC software | RadiCS | RadiCS |
| Sensors | Backlight Sensor, | |
| Integrated Front Sensor, | ||
| Presence Sensor, | ||
| Ambient Light Sensor | Backlight Sensor, | |
| Integrated Front Sensor, | ||
| Presence Sensor, | ||
| Ambient Light Sensor | ||
| USB Ports / Standard | 2 upstream, | |
| 3 downstream / Rev. 2.0 | 1 upstream, | |
| 2 downstream / Rev. 2.0 | ||
| Dimensions w/o stand | ||
| (W x H x D) | 733 x 408 x 64.5 mm | 896 x 527 x 157 mm |
It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the MX315W.
7
9. Performance Testing
The following bench tests were performed on the RadiForce MX315W.
- 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 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
- . Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance
- Visual check of presence or absence of miscellaneous artifacts on the display screen . as specified in TG18 guideline
- . Measurement of spatial resolution expressed as modulation transfer function (MTF)
- The maximum number allowed for each type of pixel defects/faults ●
The test results showed that the RadiForce MX315W has display characteristics equivalent to those of the predicate device, RadiForce RX840.
Besides, the display characteristics of the RadiForce MX315W meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce MX315W.
10. Conclusion
The RadiForce MX315W 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.