(57 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 intended use, device description, or performance studies. The focus is on display characteristics and quality control.
No
The device is a monitor intended for displaying diagnostic images for review and analysis by medical practitioners, not for directly treating a disease or condition.
No
The device is a monitor used for displaying images for diagnostic purposes, rather than being a diagnostic device itself. The diagnostic function is performed by "trained medical practitioners" who interpret the images displayed on the monitor.
No
The device description clearly describes a color LCD monitor (hardware) and includes bench testing of the monitor's display characteristics. While it mentions accompanying software (RadiCS), the primary device being submitted is the physical monitor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The RadiForce RX560 is a display monitor used for viewing medical images. It does not perform any tests on biological samples. Its function is to present visual information to a trained medical practitioner for interpretation.
- Intended Use: The intended use clearly states it's for "displaying digital images... for review, analysis and diagnosis." This is a display function, not an in vitro diagnostic test.
Therefore, the RadiForce RX560 falls under the category of medical imaging display devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
This product is intended to be used in displaying digital images, including standard and multiframe digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
RadiForce RX560 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 and the matrix size (or resolution) is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 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, RX560 and RX560-AR . The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX560 is Anti-Glare (AG) treatment and that of the RX560-AR is Anti-Reflection (AR) coating.
Two RX560 monitors mounted on a single stand configuration is available identified by with "MD" like RX560-MD and RX560-AR-MD.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX560 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 RX560.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital images, standard and multiframe 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
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 RX560 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 RX560 has display characteristics equivalent to those of the predicate device, RadiForce GX550.
Besides, the display characteristics of the RadiForce RX560 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce RX560.
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.
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
November 8, 2017
Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
EIZO Corporation % Hiroaki Hashimoto Manager 153 Shimokashiwano Hakusan, Ishikawa 924-8566 JAPAN
Re: K172738
Trade/Device Name: RadiForce RX560, RX560-AR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: September 6, 2017 Received: September 12, 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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
Page 2 - Hiroaki Hashimoto
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.
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 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) K172738
Device Name RadiForce RX560, RX560-AR
Indications for Use (Describe)
This product is intended to be used in displaying digital images, including standard and multiframe digital mammography, for review, analysis 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) |
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 EIZO logo. The logo consists of a stylized square 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 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 September 6th, 2017
4. Device Information
- Device Name: RadiForce RX560, RX560-AR ●
- Trade Name/Model: RadiForce RX560, RX560-AR
- Common Name: 54.1 cm (21.3 inch) class 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 GX550, GX550-AR (K162497)
4
6. Device Description
RadiForce RX560 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 and the matrix size (or resolution) is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 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, RX560 and RX560-AR . The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX560 is Anti-Glare (AG) treatment and that of the RX560-AR is Anti-Reflection (AR) coating.
Two RX560 monitors mounted on a single stand configuration is available identified by with "MD" like RX560-MD and RX560-AR-MD.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX560 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 RX560.
7. Indications for use
This product is intended to be used in displaying and viewing digital images, including standard and multiframe digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
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 RX560 | RadiForce GX550 | Explanation of
Differences |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display Performance/Specifications | | | |
| Screen
technology | TFT Color
LCD Panel (IPS) | TFT Monochrome
LCD Panel (IPS) | Monochrome vs. Color
(w/o & w/ color filters). |
| Viewing angle
(H, V) | H: 178°, V: 178° | H: 178°, V: 178° | |
| Resolution | 5MP (2,048 x 2,560) | 5MP (2,048 x 2,560) | |
| Aspect ratio | 4 : 5 | 4 : 5 | |
| Active screen
size | 337.9 mm x 422.4 mm | 337.9 mm x 422.4 mm | |
| Pixel pitch | 0.165 mm x 0.165 mm | 0.165 mm x 0.165 mm | |
| Maximum
luminance | 1,100 cd/m² | 2,000 cd/m² | Both devices' Maximum
and DICOM calibrated |
| DICOM
calibrated
luminance | 500 cd/m² | 600 cd/m² | 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 | 1500 : 1 | 1500 : 1 | |
| Response
Time (typical) | 12 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 (DisplayPort): 1,024
from a palette of 16,369
tones
8-bit: 256 from a palette of
16,369 tones | Monochrome vs. Color |
| Luminance
non-
uniformity
compensation | Digital Uniformity
Equalizer | Digital Uniformity
Equalizer | - |
| Video Signals | | | |
| Input video
signals | DVI-D (dual link) x 1,
DisplayPort x 1 | DVI-D (dual link) x 1,
DisplayPort x 1 | - |
| Output video
signals | DisplayPort x 1 (daisy
chain) | DisplayPort x 1 (daisy
chain) | - |
| Scanning
Frequency (H,
V) | 31 - 135 kHz / 23 - 61 Hz
Frame synchronous mode:
23.5 - 25.5 Hz, 47 - 51 Hz | 31 - 135 kHz / 23 - 61 Hz
Frame synchronous mode:
23.5 - 25.5 Hz, 47 - 51 Hz | - |
| Power Related Specifications | | | |
| Power
Requirements | AC 100 - 240 V:
50 / 60 Hz | AC 100 - 240 V:
50 / 60 Hz | - |
| Power
Consumption /
Save Mode | 87 W / Less than 1 W | 95 W / Less than 1 W | - |
| Power
Management | DVI DMPM,
DisplayPort 1.2a | DVI DMPM,
DisplayPort 1.2a | - |
| 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) | 354.5 x 452 x 78 mm | 367 x 452 x 78 mm | - |
6
It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the RX560.
7
9. Performance Testing
The bench tests below were performed on the RadiForce RX560 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 RX560 has display characteristics equivalent to those of the predicate device, RadiForce GX550.
Besides, the display characteristics of the RadiForce RX560 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce RX560.
8
10.Conclusion
The RadiForce RX560 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.