(60 days)
Not Found
No
The document describes a medical display monitor and associated quality control software. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on display characteristics and conformance to standards.
No
The device is a medical display monitor for viewing digital images for diagnosis, not a device that directly treats or prevents disease.
Yes.
The "Intended Use / Indications for Use" states that the product is intended for "review, and diagnosis by trained medical practitioners."
No
The device description clearly states that the RadiForce RX850 is a color LCD monitor, which is a hardware component. While it includes software (RadiCS), the primary device being submitted is a physical display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "displaying and viewing digital images... for review, and diagnosis by trained medical practitioners." This describes a device used to present medical images to a user, not a device that performs tests on biological samples to diagnose a condition.
- Device Description: The description details a "color LCD monitor for viewing medical images." This is a display device, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing a diagnostic result based on laboratory testing
The device is a medical image display intended for use in the diagnostic process, but it is not an in vitro diagnostic device itself.
N/A
Intended Use / Indications for Use
This product is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
Product codes
PGY
Device Description
RadiForce RX850 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. With the matrix size (or resolution) of 4,096 x 2,160 pixels (8MP), the RX850 is an alternate replacement for traditional dual head 5MP display installations.
Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "RX850" such as "RX850-AR", a model with an Anti-Reflective film lamination.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX850 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 RX850.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital images, standard and multi-frame digital mammography, breast tomosynthesis
Anatomical Site
Breast
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
No animal or clinical testing was performed on the RadiForce RX850.
Description of the test set, sample size, data source, and annotation protocol
No animal or clinical testing was performed on the RadiForce RX850.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The bench tests below were performed on the RadiForce RX850 following the instructions in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions:
- . 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
- . Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance
- . Measurement of display reflections including specular, diffuse and haze components
- Measurement of small-spot contrast ratio
- Measurement of spatial resolution expressed as modulation transfer function (MTF) ●
- Measurement of noise expressed as noise power spectrum (NPS)
- . Measurement of pixel aperture ratio
- Visual check of presence or absence of miscellaneous artifacts on the display screen ● as specified in TG18 guideline
- . Measurement of temporal response
- . Performance data on luminance stability
- . The maximum number allowed for each type of pixel defects/faults
The test results showed that the RadiForce RX850 has display characteristics equivalent to those of the predicate device, RadiForce GX540 except some items, each of which was determined that it would not affect observer's performance.
Besides, the display characteristics of the RadiForce RX850 meet the pre-defined criteria when criteria are set.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2015
EIZO Corporation % Hiroaki Hashimoto Manager of Medical Systems Standards Division 153 Shimokashiwano Hakusan, Ishikawa, 924-8566 JAPAN
Re: K152713
Trade/Device Name: 8MP Color LCD Monitor, RadiForce RX850, RX850-AR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: II Product Code: PGY Dated: September 16, 2015 Received: September 21, 2015
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.
1
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/Resourcesfor You/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 yours.
Mecha D'Hara For
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) K152713
Device Name
8MP Color LCD Monitor, RadiForce RX850, RX850-AR
Indications for Use (Describe)
This product is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
| 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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Image /page/3/Picture/0 description: The image shows the EIZO logo. The logo consists of a stylized square shape with a checkered pattern on the left and the word "EIZO" in bold, sans-serif font on the right. A registered trademark symbol is located to the upper right of the "O" in "EIZO".
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 | 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 September 15th, 2015
4. Device Information
- Trade Name/Model: RadiForce RX850, RX850-AR ●
- Common Name: 8MP Color LCD Monitor ●
- Classification Name: Display, Diagnostic Radiology
- Regulation Number: 21 CFR 892.2050, Product Code PGY ●
5. Predicate Device
- 5MP Monochrome LCD Monitor, RadiForce GX540 (K151883) ●
4
6. Device Description
RadiForce RX850 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. With the matrix size (or resolution) of 4,096 x 2,160 pixels (8MP), the RX850 is an alternate replacement for traditional dual head 5MP display installations.
Image /page/4/Picture/2 description: The image shows a computer monitor displaying two mammogram images side by side. The mammograms are grayscale and show the internal structure of the breasts. The monitor is black and has a silver stand.
RadiForce RX850
Image /page/4/Picture/4 description: The image shows two computer monitors displaying what appears to be medical scans, possibly mammograms. The monitors are side-by-side, each showing a similar image of what looks like breast tissue. The scans are in grayscale, with varying shades indicating different densities or structures within the tissue. The monitors have a black frame and are supported by a stand.
5MP Monochrome Monitors
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.
Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "RX850" such as "RX850-AR", a model with an Anti-Reflective film lamination.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX850 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 RX850.
7. Intended Use
This product is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
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:
5
| Attributes | Display Performance/Specifications | Explanation of Differences | |
|---|---|---|---|
| RadiForce RX850 / RX850-AR | RadiForce GX540 | ||
| Screen technology | TFT Color LCD Panel (IPS) | TFT Monochrome LCD Panel (IPS) | Monochrome vs. Color (w/o & w/ color filters). Eizo uses typical data for very low contrast provided by the panel manufacturers. |
| Viewing angle (H, V) | H: 178°, V: 178° | H: 176°, V: 176° | Eizo uses typical data for very low contrast provided by the panel manufacturers. |
| Resolution | 8MP (4,096 x 2,160) (4MP: 2,048 x 2,160 x 2) | 5MP (2,048 x 2,560) | The difference of 400 pixels in vertical direction is such a degree that it can be easily negated e.g. by a small amount of panning manipulation or by changing the tool bar setting of the viewer software (location, disappear when the cursor isn't on it etc.) |
| Aspect ratio | 17 : 9 (8.5 : 9 x 2) | 4 : 5 | is such a degree that it can be easily negated e.g. by a small amount of panning manipulation or by changing the tool bar setting of the viewer software (location, disappear when the cursor isn't on it etc.) |
| Active screen size | 697.9 mm x 368.0 mm | 337.9 mm x 422.4 mm | |
| Pixel pitch | 0.1704 mm x 0.1704 mm | 0.165 mm x 0.165 mm | The smaller pixel pitch or pixel size means higher density usually resulting in higher quality of displayed images. If one cares about the smaller pixel size, the perceived pixel size similar to that of the predicate device can be realized easily by adjusting the viewing distance. |
| Maximum luminance | 850 cd/m² | 1,200 cd/m² | The luminance ratio (max/min) between 250 |
| DICOM calibrated luminance | 500 cd/m² | 500 cd/m² | and 650 generally recommended taking account of the contrast sensitivity of human eyes is available in the proposed devices. EIZO does not see merits of the extremely high luminance offering contrast beyond what the eyes can see. |
| Contrast ratio | 1450 : 1 | 1200:1 | Eizo uses typical contrast ratio data provided by panel manufacturers. |
| Response Time (typical) | |||
| 20 ms (On/Off) | 25 ms (On/Off) | - | |
| Backlighting | LED | LED | LED |
| Grayscale | |||
| Tones | From a palette of 68 | ||
| billion colors: |
- 10-bit input
(DisplayPort): 1.07
billion colors
(maximum) - 8-bit input: 16.77
million colors | 10-bit (DisplayPort): 1,024
from a palette of 16,369
tones
8-bit: 256 from a palette of
16,369 tones | The smaller number of
gray tones available to
calibration of the color
display (e.g. to GSDF)
than that of the
monochrome display may
affect calibration
accuracy. |
| Luminance
non-
uniformity
compensation | Digital Uniformity
Equalizer | Digital Uniformity
Equalizer | - |
| Video Signal Input | | | |
| Input video
signals | DVI-D (dual link) x 2,
DisplayPort x 2
(two inputs are required) | DVI-D (dual link) x 1,
DisplayPort x 1 | - |
| Scanning
Frequency (H,
V) | 31 - 140 kHz / 59 - 61 Hz
(VGA Text: 69 - 71 Hz)
Frame synchronous mode:
29.5 - 30.5 Hz, 59 - 61 Hz | 31 - 135 kHz / 24 - 61 Hz
Frame synchronous mode:
24.5 - 25.5 Hz, 49 - 51 Hz | - |
| Power Related Specifications | | | |
| Power
Requirements | AC 100 - 120 V,
200 - 240 V: 50 / 60 Hz | AC 100 - 120 V,
200 - 240 V: 50 / 60 Hz | - |
| Power
Consumption /
Save Mode | 227 W / Less than 6 W | 108 W / Less than 0.7 W | The proposed device
consumes more power
due to the larger panel
size. |
| Power
Management | DVI DMPM,
DisplayPort 1.1a | 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 | 1 upstream,
2 downstream / Rev. 2.0 | 1 upstream,
2 downstream / Rev. 2.0 | - |
| Dimensions
w/o stand
(W x H x D) | 747 x 430 x 130 mm | 388 x 496 x 99 mm | Different housing design
due to the different panel
size. |
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7
It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the RX850.
9. Performance Testing
The bench tests below were performed on the RadiForce RX850 following the instructions in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions:
- . 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
- . Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance
- . Measurement of display reflections including specular, diffuse and haze components
- Measurement of small-spot contrast ratio
- Measurement of spatial resolution expressed as modulation transfer function (MTF) ●
- Measurement of noise expressed as noise power spectrum (NPS)
- . Measurement of pixel aperture ratio
- Visual check of presence or absence of miscellaneous artifacts on the display screen ● as specified in TG18 guideline
- . Measurement of temporal response
- . Performance data on luminance stability
- . The maximum number allowed for each type of pixel defects/faults
The test results showed that the RadiForce RX850 has display characteristics equivalent to those of the predicate device, RadiForce GX540 except some items, each of which was determined that it would not affect observer's performance.
Besides, the display characteristics of the RadiForce RX850 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce RX850.
8
10.Conclusion
The RadiForce RX850 was determined to be substantially equivalent to the predicate device due to the following reasons:
- The stated intended use is completely 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.