(171 days)
Not Found
No
The summary describes a medical display monitor and its performance characteristics, with no mention of AI or ML capabilities.
No
The device is a monitor intended for displaying and viewing medical images for review and analysis, not for directly treating or diagnosing patients.
No
Explanation: The device is a monitor used for displaying and viewing digital images for review and analysis, not for performing the diagnostic analysis itself. While it is used in the diagnostic process, it does not generate a diagnosis.
No
The device is explicitly described as a color LCD monitor, which is a hardware component. The performance studies also focus on hardware characteristics of the 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 including those of digital mammography for review and analysis by trained medical practitioners." This describes a device used for visualizing medical images, not for performing tests on biological samples.
- Device Description: The description clearly states it's a "color LCD monitor for viewing medical images."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would fall under the definition of an in vitro diagnostic device.
IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a display for viewing images generated by other medical devices (like mammography machines).
N/A
Intended Use / Indications for Use
The RadiForce RX840-MG is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The RadiForce RX840-MG 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 RX840-MG is an alternate replacement for traditional dual head 5MP 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. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX840-MG based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce RX840-MG.
Mentions image processing
Not Found
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 RX840-MG following 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 agreed with the . manufacturer from which Eizo buys the LCD panels for RadiForce RX840-MG
The test results showed that the RadiForce RX840-MG has display characteristics equivalent to those of the predicate device, RadiForce GX530 except 4 items, each of which was determined that it would not affect observer's performance. Besides, the display characteristics of the RadiForce RX840-MG meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce RX840-MG.
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
K|2045|
Image /page/0/Picture/1 description: The image shows the logo for EIZO. The logo consists of a square shape with a checkered pattern on the left side and the word "EIZO" in bold letters on the right side. The logo is black and white and has a registered trademark symbol next to the letter O.
3 2012 AUG
| Name | Hiroaki Hashimoto | |
|---|---|---|
| Department | Medical System Standards | |
| U.S. Food and Drug Administration | ||
| Center for Devices and Radiological Health | Telephone | +81 (76) 274-2468 |
| Document Mail Center – WO66-G609 | Fax | +81 (76) 274-2484 |
| 10903 New Hampshire Avenue | ||
| Silver Spring, MD 20993-0002 | hiro@nanao.co.jp | |
| Date | February 3rd, 2012 |
Traditional 510(k) Summary (in accordance with 21 CFR 807.92)
1. Date of Summary
February 3rd, 2012
2. Company
EIZO NANAO CORPORATION 153 Shimokashiwano, Hakusan Ishikawa 924-8566 Japan
3. Authorized Contact Person
Hiroaki Hashimoto
4. Device Information
- Trade Name/Model: RadiForce RX840-MG .
- Common Name: 8MP Color LCD Monitor .
- Classification Name: System, Image Processing, Radiological .
- 21 CFR 892.2050, Product Code LLZ . Regulation Number:
5. Predicate Device
- . 5MP Monochrome LCD Monitor, RadiForce GX530 (K112354)
1
6. Device Description
The RadiForce RX840-MG 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 RX840-MG is an alternate replacement for traditional dual head 5MP display installations.
Image /page/1/Picture/2 description: The image shows two different medical monitors. The monitor on the left is a RadiForce RX360-MG, and the two monitors on the right are 5MP monitors. All three monitors are displaying medical images. The monitors are all black and have a thin bezel.
RadiForce RX840-MG
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. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX840-MG based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce RX840-MG.
7. Intended Use
The RadiForce RX840-MG is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.
2
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
RX840-MG | Eizo RadiForce
GX530 | 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).
See main text. |
| Viewing
angle (H, V) | H: 176°, V: 176° | H: 170°, V: 170° | Eizo uses the typical data
for very low contrast 10:1
given by the panel
manufacturers |
| Active screen
size | 817.1 x 430.9 mm
(408.05 x 430.9 mm x 2) | 337.9 x 422.4mm | The difference of 400
pixels in vertical
direction |
| Resolution | 8 MP (4,096 x 2,160)
(4MP: 2,048 x 2,160 x 2) | 5 MP (2,048 x 2,560) | 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 | |
| Pixel pitch | 0.1995 x 0.1995 mm | 0.165 x 0.165 mm | |
| Maximum
luminance | 700 cd/m² | 1,200 cd/m² | Smaller maximum
luminance value means
shorter period during
which calibrated
luminance can be
guaranteed: RX840-MG:
10K hours vs. GX530:
40K hours. |
| DICOM
calibrated
luminance | 500 cd/m² | 500 cd/m² | |
| Contrast ratio | 1000: 1 | 1200 : 1 | Eizo uses typical contrast
ratio data provided by
panel manufacturers. |
| Backlighting | LED | CCFL | See main text. |
| Grayscale
Tones | 10-bit:
1,024 from a palette of
4,096 tones
8-bit: 256 from a palette
of 4096 tones | 10-bit (DisplayPort):
1,024 from a palette of
16,369 tones
8-bit: 256 from a palette
of 16,369 tones | See main text. |
| Luminance
non-
uniformity
compensation | Digital Uniformity
Equalizer (DUE) | Digital Uniformity
Equalizer (DUE) | |
| Video Signal Input | | | |
| Input video
signals | DVI-D (Dual Link) x 2,
DisplayPort x 2 | DVI-D (Dual Link) x 1 ,
DisplayPort x 1 | |
| Scanning
Frequency
(H, V) | 31 - 140 kHz, 29.5 - 30.5
Hz (2048 x 2160, 1920 x
2160), 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
(VGA Text: 69 - 71 Hz)
Frame synchronous
mode: 24.5 - 25.5 Hz,
49 - 51 Hz | |
| Dot Clock | DVI-D: 310 MHz,
DisplayPort: 290 MHz | 290 MHz | |
| Display
controller | Off the shelf | Off the shelf | |
| 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 | 350 W / Less than 6 W | 130 W / Less than 2.5 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 (BS),
Integrated Front Sensor
(IFS),
Presence Sensor (PS),
Ambient Light Sensor
(ALS) | Backlight Sensor (BS),
Integrated Front Sensor
(IFS),
Presence Sensor (PS),
Ambient Light Sensor
(ALS) | |
| USB Ports / | 1 upstream, | 1 upstream, | |
| Standard | 2 downstream / Rev. 2.0 | 2 downstream / Rev. 2.0 | |
| Dimensions
w/o stand
(W x H x D) | 896 x 527 x 157 mm | 388 x 496 x 99 mm | Different housing design
due to the different panel
size. |
3
4
For the substantial equivalence determination, only the following differences of the technological characteristics need further evidences by performance testing:
- ' The RadiForce RX840-MG employs a color LCD panel module though the predicate device employs a monochrome LCD panel module.
- . 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.
- -The RadiForce RX840-MG employs an LED backlight though the predicate device employs a CCFL backlight; advantage of the LED backlight is that it is mercury-free, consumes less power and deteriorates more slowly.
9. Performance Testing
The following bench tests were performed on the RadiForce RX840-MG following 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 agreed with the . manufacturer from which Eizo buys the LCD panels for RadiForce RX840-MG
5
The test results showed that the RadiForce RX840-MG has display characteristics equivalent to those of the predicate device, RadiForce GX530 except 4 items, each of which was determined that it would not affect observer's performance. Besides, the display characteristics of the RadiForce RX840-MG meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce RX840-MG.
10. Conclusion
The 8MP Color LCD Monitor, RadiForce RX840-MG to be used in dual-head configuration has the same intended use as the predicate device but some different technological characteristics. Bench testing showed that the safety and effectiveness of the RadiForce RX840-MG was not affected by the differences of the technological characteristics. Therefore, the RadiForce RX840-MG was determined to be substantially equivalent to the predicate device.
6
Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tails, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The text is in all caps and is written in a sans-serif font. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002
3 2012 AUG
Mr. Hiroaki Hashimoto Manager EIZO NANAO Corporation 153 Shimokashiwano HAKUSAN ISHIKAWA 924-8566 JAPAN
Re: K120451
Trade/Device Name: 8MP Color LCD Monitor, RadiForce RX840-MG Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 17, 2012 Received: July 19, 2012
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, 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 I o a may) ontrols 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 class II (Special Controls), it may be subject to such 11 Jour wortols. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 r total of acreating 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 compy "Har an an an an and 809); medical device reporting (reporting (reporting of
7
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 Diagnostic Device Evaluation and Safety 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,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Indications for Use Form
510(k) Number (if known): _
8MP Color LCD Monitor, RadiForce RX840-MG Device Name:
Indications for Use:
The RadiForce RX840-MG is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.
Over-The-Counter Use X 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 Diagnostic Devices (OIVD)
Division Sign-Off
sion Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K1200451
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