(35 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 for image analysis, diagnosis, or any other function. The performance studies focus on display characteristics and conformance to standards, not algorithmic performance.
No
The device is a color LCD monitor intended for displaying and viewing digital images for review and analysis by trained medical practitioners, which is not a direct therapeutic function.
No
Explanation: This device is a medical display monitor for viewing medical images. While it is used in the process of diagnosis by trained medical practitioners, the device itself does not perform any diagnostic function (e.g., image analysis, disease detection, or measurement of physiological parameters). It is a display accessory that supports diagnostic activities.
No
The primary device described is a color LCD monitor (RadiForce RX650), which is a hardware component. While the submission includes software (RadiCS) as an accessory, 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 "displaying and viewing digital images for review and analysis by trained medical practitioners." This describes a device used for visualizing medical images, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description clearly states it's a "color LCD monitor for viewing medical images." Monitors are output devices for displaying information, not devices that perform in vitro diagnostic tests.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, reagents, or performing tests outside of the body.
The device is a medical image display monitor, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
RadiForce RX650 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. With the matrix size (or resolution) of 3,280 x 2,048 pixels (6MP), the RX650 is an optimum replacement for traditional dual head 3MP display installations.
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 RX650 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 RX650.
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 following bench tests were performed on the RadilForce RX650.
- 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 the TG18 guideline
- Measurement of the chromaticity non-uniformity characteristics of the display screen as . specified in the TG18 guideline
- Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% . of the maximum luminance as specified in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket · Notification (510(k)) Submissions
- Visual check of presence or absence of miscellaneous artifacts on the display screen as . specified in the TG18 guideline
- The maximum number allowed for each type of pixel defects/faults .
The test results showed that the RadiForce RX650 has display characteristics equivalent to those of the predicate device, RadiForce RX340.
Besides, the display characteristics of the RadiForce RX650 meet the pre-delined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce RX650.
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
Image /page/0/Picture/0 description: The image shows the logo for EIZO. The logo consists of a stylized diamond shape on the left and the word "EIZO" on the right. The diamond shape is made up of a grid of squares, some of which are filled in with black. The word "EIZO" is written in a bold, sans-serif font. There is a registered trademark symbol next to the "O" in "EIZO".
K134002
Page 1 of 5
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 Standard
JAN 3 1 2014
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
-
- Contact Person
Hiroaki Hashimoto
- Contact Person
3. Date of Summary December 20th, 2013
- Device Information
- Trade Name/Model: RadiForce RX650 .
- Common Name: 6MP Color LCD Monitor .
- Classification Name: System. Image Processing. Radiological ●
- 21 CFR 892.2050. Product Code LLZ Regulation Number: .
5. Predicate Device
- 3MP Color LCD Monitor, RadiForce RX340 (K113562) .
1
6. Device Description
RadiForce RX650 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. With the matrix size (or resolution) of 3,280 x 2,048 pixels (6MP), the RX650 is an optimum replacement for traditional dual head 3MP display installations.
Image /page/1/Picture/2 description: The image shows a RadiForce RX650 monitor displaying medical images. The screen is divided into two sections, each displaying a different medical scan. The left side is labeled "3MP", the right side is labeled "3MP", and the top is labeled "6MP", indicating the resolution or image size of each section.
RadiForce RX650
Image /page/1/Picture/4 description: The image shows two computer monitors displaying medical imaging data. Each monitor shows a series of scans, likely from a CT or MRI, displaying anatomical structures. The scans appear to focus on blood vessels and organs, possibly related to the renal system. The monitors are identical, suggesting a side-by-side comparison or a duplicated display for medical analysis.
3MP Color Displays
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 RX650 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 RX650.
7. Intended Use
This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
8. Comparison of Technological Characteristics
The comparison table below enumerates information derived from the product brochures of the each device and different technological characteristics are discussed:
2
| Attributes | Eizo RadiForce
RX650 | Eizo RadiForce
RX340 | Explanation of
Differences |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display Performance/Specifications | | | |
| Screen
technology | TFT Color LCD Panel
(IPS) | TFT Color LCD Panel
(IPS) | |
| Viewing
angle (H. V) | H: 176°, V: 176° | H: 170°, V: 170° | Eizo uses typical data for
very low contrast
provided by the panel
manufacturers |
| Active screen
size | 645.5 mm x 403.0 mm | 323.7 mm x 431.6 mm | |
| Resolution | 6MP (3,280 x 2,048) | 3MP (1,536 x 2,048) | |
| Aspect ratio | 16:10 | 3 : 4 | |
| Pixel pitch | 0.197 mm x 0.197 mm | 0.21075 mm x 0.21075
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 | 800 cd/m² | 1,000 cd/m² | Though the smaller
maximum luminance
value usually results in
shorter period during
which the calibrated
luminance can be
guaranteed, the
guaranteed operating
periods of the both
devices are the same. |
| DICOM
calibrated
luminance | 400 cd/m² | 400 cd/m² | |
| Contrast ratio | 1000 : 1 | 1400 : 1 | Eizo uses typical contrast
ratio data provided by
panel manufacturers. |
| Backlighting | LED | LED | |
| Display
Colors | From a palette of 68
billion colors:
- 10-bit (DisplayPort):
1.07 billion colors
(maximum) - 8-bit colors: 16.77
million colors | From a palette of 68
billion colors: - 10-bit (DisplayPort):
1.07 billion colors
(maximum) - 8-bit colors: 16.77
million colors | |
| 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 - 129 kHz / 29 - 61 Hz
(VGA Text: 69 - 71 Hz)
Frame synchronous
mode: 29.5 - 30.5 Hz. 59 - 61 Hz | 31 - 127 kHz. 29 - 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 - 120 V,
200 - 240 V: 50 / 60 Hz | AC 100 - 120 V,
200 - 240 V: 50 / 60 Hz | |
| Power
Consumption
/ Save Mode | 225 W / Less than 6 W | 125 W / Less than 3 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) | 692 x 466 x 109 mm | 376 x 505 x 98 mm | Different housing design
due to the different panel
size. |
.
.
.
3
It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the RX650.
.
4
K134002
Page 5 of 5
9. Performance Testing
The following bench tests were performed on the RadilForce RX650.
- 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 the TG18 guideline
- Measurement of the chromaticity non-uniformity characteristics of the display screen as . specified in the TG18 guideline
- Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% . of the maximum luminance as specified in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket · Notification (510(k)) Submissions
- Visual check of presence or absence of miscellaneous artifacts on the display screen as . specified in the TG18 guideline
- The maximum number allowed for each type of pixel defects/faults .
The test results showed that the RadiForce RX650 has display characteristics equivalent to those of the predicate device, RadiForce RX340.
Besides, the display characteristics of the RadiForce RX650 meet the pre-delined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce RX650.
10.Conclusion
The RadiForce RX650 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 and the effectiveness.
- The bench tests demonstrated that the display characteristics are equivalent to those of . the predicate device.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an abstract human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the graphic. The text and the graphic are both in black, set against a white background.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
January 31, 2014
EIZO Corporation % Mr. Hiroaki Hashimoto Manager 153 Shimokashiwano, Hakusan Ishikawa 924-8566 JAPAN
Re: K134002
Trade/Device Name: 6MP Color LCD Monitor, RadiForce RX650 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 31, 2013 · Received: January 7, 2014
Dear Mr. 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. Drue, 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. Iisting 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.
6
Page 2-Mr. Hashimoto
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/Medicall.cevices/Resourcesfor You/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/McdicalDevices/SafetyReportaProblem/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 Small Manufacturers, International and Consumer Assistance 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,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Indications for Use
| 510(k) Number (if known): | K134002 |
|---|---|
| Device Name: | 6MP Color LCD Monitor, RadiForce RX650 |
| Indications for Use: | This product is intended to be used in displaying and viewing |
| digital images for review and analysis by trained medical | |
| practitioners. It does not support the display of mammography | |
| images for diagnosis. |
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR)
$(m_{i})$
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K134002 510(k)
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