(17 days)
No
The description focuses on the hardware (LCD monitor) and basic software for quality control. There is no mention of AI, ML, or any advanced image processing that would typically involve these technologies. The performance studies are standard bench tests for display characteristics.
No
The device is a color LCD monitor intended for displaying digital images for review, analysis, and diagnosis by trained medical practitioners. It does not perform any therapeutic function.
No
Explanation: This device is a medical monitor designed for displaying digital images for review, analysis, and diagnosis. While it is used in the diagnostic process, it does not perform the diagnosis itself; it is a display tool for trained medical practitioners.
No
The device description clearly states that the primary device is a color LCD monitor (hardware) and the software (RadiCS) is included as an accessory.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "displaying digital images for review, analysis and diagnosis by trained medical practitioners." This describes a device used for viewing medical images, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description details a color LCD monitor designed for viewing medical images. It focuses on display characteristics like resolution, tone curves, and surface treatment. There is no mention of reagents, assays, or any components typically associated with in vitro diagnostics.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information based on laboratory tests
The device is clearly 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 digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Product codes
PGY
Device Description
RadiForce RX660 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 3,280 x 2,048 pixels (6MP) with a pixel pitch of 0.1968 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, RX660 and RX660-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX660 is Anti-Glare (AG) treatment and that of the RX660-AR is Anti-Reflection (AR) coating.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX660 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 RX660.
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
The following bench tests were performed on the RadiForce RX660.
- 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 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
- Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline
- Measurement of spatial resolution expressed as modulation transfer function (MTF)
- The maximum number allowed for each type of pixel defects/faults
The test results showed that the RadiForce RX660 has display characteristics equivalent to those of the predicate device. RadiForce RX650.
Besides, the display characteristics of the RadiForce RX660 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce RX660.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2016
EIZO Corporation % Mr. Hiroaki Hashimoto Manager, Medical System Standards 153 Shimokashiwano Hakusan, Ishikawa 924-8566 JAPAN
Re: K163335
Trade/Device Name: 6MP Color LCD Monitor, RadiForce RX660, RX660-AR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: November 24, 2016 Received: November 28, 2016
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 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 (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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Michael D'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) K163335
Device Name
6MP Color LCD Monitor, RadiForce RX660, RX660-AR
Indications for Use (Describe)
This product is intended to be used in displaying digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for EIZO. The logo consists of a stylized square shape on the left and the word "EIZO" in bold, sans-serif font on the right. The square shape is divided into smaller squares, some of which are filled in with a darker color, creating a checkered pattern. A small registered trademark symbol is located to the upper right of the letter "O".
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
Hiroaki Hashimoto Name Department Medical System Standards
Telephone +81 (76) 274-2468 Fax E-Mail
+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
3. Date of Summary November 24th, 2016
4. Device Information
- Device Name: 6MP Color LCD Monitor, RadiForce RX660, RX660-AR
- Trade Name/Model: RadiForce RX660, RX660-AR ●
- Common Name: 6MP Color LCD Monitor ●
- Classification Name: ● Display, Diagnostic Radiology
- Regulation Number: 21 CFR 892.2050, Product Code PGY ●
5. Predicate Device
6MP Color LCD Monitor, RadiForce RX650 (K134002)
4
6. Device Description
RadiForce RX660 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 3,280 x 2,048 pixels (6MP) with a pixel pitch of 0.1968 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, RX660 and RX660-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX660 is Anti-Glare (AG) treatment and that of the RX660-AR is Anti-Reflection (AR) coating.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX660 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 RX660.
7. Indications for use
This product is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
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 RX660 | RadiForce RX650 | 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: 176°, V: 176° | - | | | | | | | | |
| Resolution | 6MP (3,280 x 2,048) | 6MP (3,280 x 2,048) | - | | | | | | | | |
| Aspect ratio | 16:10 | 16:10 | - | | | | | | | | |
| Active screen
size | 645.5 mm x 403.0 mm | 645.5 mm x 403.0 mm | - | | | | | | | | |
| Pixel pitch | 0.1968 mm x 0.1968 mm | 0.197 mm x 0.197 mm | - | | | | | | | | |
| Maximum
luminance | 1,000 cd/m² | 800 cd/m² | - | | | | | | | | |
| DICOM
calibrated
luminance | 500 cd/m² | 400 cd/m² | - | | | | | | | | |
| Contrast ratio | 1500 : 1 | 1000:1 | - | | | | | | | | |
| Response
Time (typical) | 25 ms (On/Off) | 30 ms (On/Off) | - | | | | | | | | |
| 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 Signals | | | | Input video
signals | DVI-D (dual link) x 1,
DisplayPort x 2 | DVI-D (dual link) x 2,
DisplayPort x 2
(two inputs are required) | - | Output video
signals | DisplayPort x 1 (daisy
chain) | | - |
| Video Signals | | | | | | | | | | | |
| Input video
signals | DVI-D (dual link) x 1,
DisplayPort x 2 | DVI-D (dual link) x 2,
DisplayPort x 2
(two inputs are required) | - | | | | | | | | |
| Output video
signals | DisplayPort x 1 (daisy
chain) | | - | | | | | | | | |
6
| Scanning
Frequency (H,
V) | 31 - 127 kHz / 22 - 61 Hz
(VGA Text: 69 - 71 Hz)
Frame synchronous mode:
29.5 - 30.5 Hz, 59 - 61
Hz | 31 - 129 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 - 240 V:
50 / 60 Hz | AC 100 - 120 V,
200 - 240 V: 50 / 60 Hz | |
| Power
Consumption /
Save Mode | 190 W / Less than 1.6 W | 225 W / Less than 6 W | |
| Power
Management | DVI DMPM,
DisplayPort 1.2a | 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 | 2 upstream,
3 downstream / Rev. 2.0 | 1 upstream,
2 downstream / Rev. 2.0 | |
| Dimensions
w/o stand
(W x H x D) | 682.5 x 441 x 88 mm | 692 x 466 x 109 mm | Different housing
design. |
It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the RX660.
7
9. Performance Testing
The following bench tests were performed on the RadiForce RX660.
- . 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 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
- . Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline
- . Measurement of spatial resolution expressed as modulation transfer function (MTF)
- The maximum number allowed for each type of pixel defects/faults
The test results showed that the RadiForce RX660 has display characteristics equivalent to those of the predicate device. RadiForce RX650.
Besides, the display characteristics of the RadiForce RX660 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce RX660.
10. Conclusion
The RadiForce RX660 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.