(28 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 processing beyond standard display functions.
No.
The device is a monitor intended for viewing digital images for review and analysis, not for providing therapy or treatment.
No
The device is a medical monitor intended for viewing and analyzing digital images, not for performing a diagnostic function itself. It supports the work of trained medical practitioners in their diagnostic process, but it does not diagnose.
No
The device description clearly states it is a color LCD monitor (hardware) and includes performance studies related to the physical display characteristics. While it mentions accompanying software (RadiCS), the primary 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 in conjunction with diagnostic procedures, but not a device that performs the diagnostic test itself.
- Device Description: The device is a "color LCD monitor for viewing medical images." Monitors are display devices, not diagnostic tests.
- Lack of IVD Characteristics: IVD devices typically involve analyzing biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status. This device does not interact with biological samples in any way.
- Performance Studies: The performance studies focus on the technical characteristics of the display (DICOM conformance, luminance, chromaticity, pixel defects), which are relevant to image quality for viewing, not to the accuracy of a diagnostic test.
In summary, the RadiForce RX440 is a medical image display device, which is a different category of medical device than an In Vitro Diagnostic.
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
The RadiForce RX440 is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 2,560 x 1,600 pixels (4MP) with a pixel pitch of 0.2505 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.
Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "RX440" such as "RX440-AR", a model with an Anti-Reflective coating on the screen surface although the hardware design, components and labeling remain unchanged.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX440 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce RX440.
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
The following bench tests were performed on the RadiForce RX440:
- 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 agreed with the manufacturer from which Eizo buys the LCD panels for RadiForce RX440
None of the tests revealed behaviors inconsistent with the expected performance.
No animal or clinical testing was performed on the RadiForce RX440.
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
R 130070
Image /page/0/Picture/1 description: The image shows the logo for EIZO. The logo consists of a stylized square made up of smaller squares on the left and the word "EIZO" in block letters on the right. There is a registered trademark symbol next to the "O" in "EIZO".
Eizo Nanao 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
510(k) Summary (in accordance with 21 CFR 807.92)
1. Company
Eizo Nanao Corporation 153 Shimokashiwano. Hakusan Ishikawa 924-8566 Japan Tel: +81 (76) 274-2468 Fax: +81 (76) 274-2484
2. Contact Person
Hiroaki Hashimoto
3. Date of Summary
December 25th, 2012
4. Device Information
- Trade Name/Model: RadiForce RX440 .
- 4MP Color LCD Monitor . Common Name:
- . Classification Name: System, Image Processing, Radiological
- Regulation Number: 21 CFR 892.2050, Product Code LLZ
5. Predicate Device
.
- 4MP Color LCD Monitor, RadiForce RX430 (K112466) .
FEB 0 8 2013
1
6. Device Description
The RadiForce RX440 is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 2,560 x 1,600 pixels (4MP) with a pixel pitch of 0.2505 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.
Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "RX440" such as "RX440-AR", a model with an Anti-Reflective coating on the screen surface although the hardware design, components and labeling remain unchanged.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX440 based on the OC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce RX440.
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 literature of the each device and different technological characteristics are discussed in it:
| Attributes | Eizo RadiForce RX440 | Eizo RadiForce RX430 | 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° @CR=10 | H: 170°, V: 170° @CR=50 | Eizo uses typical data for very low contrast provided by the panel manufacturers |
| Active screen size | 641.28 mm x 400.8 mm | 641.28 mm x 400.8 mm | - |
| Resolution | 4MP (2,560 x 1,600) | 4MP (2,560 x 1,600) | - |
| Aspect ratio | 16:10 | 16:10 | - |
| Pixel pitch | 0.2505 mm x 0.2505 mm | 0.2505 mm x 0.2505 mm | - |
| Maximum luminance | 750 cd/m² | 1,000 cd/m² | Though smaller maximum luminance |
| DICOM | |||
| calibrated | |||
| luminance | 400 cd/m² | 400 cd/m² | value usually means |
| shorter warranty period of | |||
| the calibrated luminance, | |||
| the warranty period of the | |||
| proposed device is longer | |||
| than that of the predicate | |||
| device due to the LED | |||
| backlight deteriorating | |||
| more slowly than the | |||
| CCFL backlight. | |||
| Contrast ratio | 1100:1 | 1100:1 | Eizo uses typical contrast |
| ratio data provided by | |||
| panel manufacturers. | |||
| Backlighting | LED | CCFL | See main text below. |
| Display | |||
| Colors | 10-bit colors | ||
| 1.07 Billion (maximum) | |||
| colors | |||
| 8-bit colors: | |||
| 16.77 million from a | |||
| palette of 68 billion | |||
| colors | 10-bit colors | ||
| 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 Signal Input | |||
| Input video | |||
| signals | DVI-D (dual link) x 1, | ||
| DVI-D (single link) x 1, | |||
| DisplayPort x 1 | DVI-D (dual link) x 1 , | ||
| DisplayPort x 1 | |||
| Scanning | |||
| Frequency | |||
| (H, V) | 31 -- 159 kHz, 29 - 61 Hz | ||
| (VGA Text: 69 - 71 Hz) | |||
| Frame synchronous | |||
| mode: 59 - 61 Hz, 29.5 - | |||
| 30.5 Hz | 31 - 100 kHz, 29.5 - 61 | ||
| Hz (VGA Text: 69 - 71 | |||
| Hz) | |||
| Frame synchronous | |||
| mode: 59 - 61 Hz, 29.5 - | |||
| 30.5 Hz | Wider frequency ranges | ||
| are supported by the | |||
| proposed device. | |||
| Dot Clock | 280 MHz | 290 MHz | |
| 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 | 167 W / Less than 0.7 W | 200 W / Less than 1 W | The proposed device |
| consumes less power than | |||
| the predicate device. | |||
| 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) | 720 x 498 x 119 mm | 720 x 498 x 119 mm | - |
2
:
・
3
For the substantial equivalence determination, only the difference of the backlights needs further evidences by performance testing.
.
.
4
9. Performance Testing
The following bench tests were performed on the RadiForce RX440:
- 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 agreed with the manufacturer from which Eizo buys the LCD panels for RadiForce RX440
None of the tests revealed behaviors inconsistent with the expected performance.
No animal or clinical testing was performed on the RadiForce RX440.
10. Conclusion
The 4MP Color LCD Monitor, RadiForce RX440 is substantially equivalent to the predicate device with respect to technical characteristics, performance, application and intended use. The specifications of the primary component employed by the proposed device are the same as those of the predicate device and other differences have been independently validated. Any differences between the devices do not affect safety or effectiveness.
5
Image /page/5/Picture/0 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 abstract symbol resembling an eagle or bird-like figure with three stylized wing or feather shapes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
February 8, 2013
Eizo Nanao Corporation c/o Hiroaki Hashimoto, Manager Medical Systems Standards 153 Shimokashiwano Hakusan JAPAN 924-8566
Re: K130070
Trade/Device Name: RadiForce RX440 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: January 9, 2013 Received: January 18, 2013
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.
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
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Page 2 – Hiroaki Hashimoto
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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/cdrh/industry/support/index.html.
Sincerely yours,
Sean M. Boyd -S 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 Form
510(k) Number (if known):
4MP Color LCD Monitor, RadiForce RX440 Device Name:
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.
X Over-The-Counter Use Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Sean M. Boyd -S
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k) K130070
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