(76 days)
Not Found
No
The description focuses on the technical specifications of a medical display monitor and its associated quality control software. There is no mention of AI or ML capabilities for image analysis or interpretation.
No
The device is a monitor intended for displaying and viewing digital images for review and analysis, not for providing therapy or treatment.
No
The device is a monitor used for displaying and viewing medical images for review and analysis, not for performing the diagnostic assessment itself. It explicitly states it "does not support the display of mammography images for diagnosis." While involved in the diagnostic workflow, it's a display accessory, not a diagnostic device.
No
The primary device described is a color LCD monitor (RadiForce MX215), which is a hardware component. While the submission includes software (RadiCS and RadiCS LE) 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 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 device is a color LCD monitor designed for viewing medical images. It focuses on display characteristics like resolution, tone curves (DICOM GSDF), luminance, and color temperature. While it includes software for quality control of the display, this is related to the performance of the monitor itself, not to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), reagents, or any process that would involve analyzing these samples to provide diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, treatment, or prevention of disease. This monitor's function is to display images generated by other medical devices (like X-ray machines, CT scanners, etc.) for interpretation by a medical professional.
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
LLZ
Device Description
RadiForce MX215 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 1.200 x 1.600 pixels (2MP).
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 MX215 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 MX215.
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 RadiForce MX215.
- 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 MX215 has display characteristics equivalent to those of the predicate device, RadiForce RS210.
Besides, the display characteristics of the RadiForce MX215 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce MX215.
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).
0
Image /page/0/Picture/0 description: The image shows the logo for EIZO. The logo consists of a square made up of smaller black and white squares on the left, and the word "EIZO" in bold black letters on the right. There is a registered trademark symbol next to the "O" in "EIZO".
KB31090
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JUL 0 3 2013
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 lshikawa 924-8566 Japan Tel: +81 (76) 274-2468 Fax: +81 (76) 274-2484
- Contact Person
Hiroaki Hashimoto
3. Date of Summary April 15th, 2013
4. Device Information
- Trade Name/Model: RadiForce MX215 .
- Common Name: 2MP Color LCD Monitor .
- . Classification Name: System, Image Processing, Radiological
- Regulation Number: 21 CFR 892.2050, Product Code LLZ .
5. Predicate Device
- 2MP Color LCD Monitor, RadiForce RS210 (K092613) .
1
6. Device Description
RadiForce MX215 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 1.200 x 1.600 pixels (2MP).
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 MX215 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 MX215.
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
MX215 | Eizo RadiForce
RS210 | Explanation of
Differences |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display Performance/Specifications | | | |
| Screen
technology | TFT Monochrome LCD
Panel (IPS) | TFT Monochrome LCD
Panel (IPS) | |
| Viewing
angle (H, V) | H: 178°, V: 178° | H: 170°, V: 170° | Eizo uses typical data for
very low contrast
provided by the panel
manufacturers |
| Active screen
size | 324.0 mm x 432.0 mm | 432.0 mm x 324.0 mm | |
| Resolution | 2MP (1,200 x 1,600) | 2MP (1,600 x 1,200) | |
| Aspect ratio | 3 : 4 | 4 : 3 | |
| Pixel pitch | 0.270 mm x 0.270 mm | 0.270 mm x 0.270 mm | |
| Maximum
luminance | 420 cd/m² | 300 cd/m² | |
| DICOM
calibrated
luminance | 180 cd/m² | 150 cd/m² | |
| Contrast ratio | 1500 : 1 | 1000 : 1 | Eizo uses typical contrast
ratio data provided by
panel manufacturers. |
| Backlighting | LED | CCFL | See main text. |
| 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-I x 1,
DisplayPort x 1 | DVI-I x 2 ,
DisplayPort x 1 | |
| Scanning
Frequency
(H, V) | Digital : 31 - 76 kHz / 59 - 61 Hz (VGA Text: 69 -
71 Hz)
Analog : 26 - 80 kHz / 49 - 76 Hz | Digital : 31 - 100 kHz /
59 - 61 Hz (VGA Text:
69 - 71 Hz)
Analog : 31 - 100 kHz /
49 - 86 Hz (1600 x 1200:
49 - 61 Hz) ,
Frame synchronous
mode: 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 | 48 W / Less than 0.5 W | 64 W / Less than 1 W | - |
| Power
Management | Digital: DVI DMPM,
DisplayPort 1.1a
Analog: VESA DPM | Digital: DVI DMPM,
DisplayPort 1.1a
Analog: VESA DPM | - |
| Miscellaneous Features/Specifications | | | |
| QC software | RadiCS | RadiCS | - |
| Sensors | Backlight Sensor (BS),
Integrated Front Sensor (IFS),
Presence Sensor (PS) | Backlight Sensor | Among two sensors not
implemented on RS210,
only the IFS has
something to do with the
maintenance or the
calibration; the PS detects
the absence of the user to
trigger the power saving
mode of the monitor.
The IFS enables
automatic grayscale
calibration by measuring
the luminance at the
screen surface. |
| 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) | 360 x 485 x 64 mm | 472 x 373 x 69 mm | Different housing design
due to the different panel
size |
3
For the substantial equivalence determination, only the difference of the backlight technologies needs further evidences by performance testing.
.
:
:
4
K131090
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9. Performance Testing
The following bench tests were performed on the RadiForce MX215.
- 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 MX215 has display characteristics equivalent to those of the predicate device, RadiForce RS210.
Besides, the display characteristics of the RadiForce MX215 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce MX215.
10.Conclusion
The 2MP Color LCD Monitor, RadiForce MX215 has the same intended use as the predicate device but has one different technological characteristics. Bench testing showed that the safety and effectiveness of the RadiForce MX215 was not affected by the difference of the technological characteristics. Therefore, the RadiForce MX215 was determined to be substantially equivalent to the predicate device.
5
DEPARTMENT OF BEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle with three wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-C1609 Silver Spring, MD 20993-0002
July 3, 2013
EIZO Corporation % Mr. Hiroaki Hashimoto Manager 153 Shimokashiwano. Hakusan lshikawa 924-8566 JAPAN
Re: K131090
Trade/Device Name: 2MP Color LCD Monitor, RadiForce MX215 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: April 18, 2013 Received: May 2. 2013
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 10 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
6
Page 2 - Mr. Hashimoto
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/orYou/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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Jaming M. Menge
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): K 131090
Device Name:
2MP Color LCD Monitor, RadiForce MX215
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)
Ramingh. Hess.
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K131090 510(k)
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