(21 days)
RadiForce MX242W (K143261)
Not Found
No
The description focuses on the display technology, calibration, and quality control software, with no mention of AI or ML capabilities for image analysis or processing.
No.
This device is a display monitor for viewing radiological images for diagnosis, not for providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product is "indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners." The term "diagnosis" directly implies a diagnostic purpose.
No
The primary device described is a color LCD monitor (RadiForce MX243W), which is a hardware component. While the submission includes software (RadiCS) as an accessory, the core device is a physical display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to display radiological images for review, analysis, and diagnosis. This is related to medical imaging, not in vitro testing of biological samples.
- Device Description: The device is a color LCD monitor designed for viewing medical images. It describes the technical specifications of the display itself, not a system for analyzing biological samples.
- No mention of in vitro testing: The entire description focuses on the display of images and associated quality control software. There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to present visual information from imaging modalities, which is a different category of medical device.
N/A
Intended Use / Indications for Use
This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
RadiForce MX243W 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 1,920 x 1,200 pixels (2.3MP) with a pixel pitch of 0.270 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.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce MX243W 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 MX243W.
RadiCS is of Minor level of concern and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce MX243W and it's not a medical imaging software.
Mentions image processing
No
Mentions AI, DNN, or ML
No
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 bench tests below were performed on the RadiForce MX243W following the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on October 2, 2017:
- . Measurement of spatial resolution expressed as modulation transfer function (MTF)
- The maximum number allowed for each type of pixel defects/faults
- . Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline
- Measurement of temporal response
- Measurement of Luminance
- 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 pixel aperture ratio
- Measurement of Color tracking ●
The test results showed that the RadiForce MX243W has display characteristics equivalent to those of the predicate device, RadiForce MX242W.
Besides, the display characteristics of the RadiForce MX243W meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce MX243W.
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.
RadiForce MX242W (K143261)
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 of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
EIZO Corporation % Hiroaki Hashimoto Senior Manager 153 Shimokashiwano Hakusan, Ishikawa 924-8566 JAPAN
Re: K221136
Trade/Device Name: RadiForce MX243W Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: April 14, 2022 Received: April 19, 2022
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221136
Device Name RadiForce MX243W
Indications for Use (Describe)
This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
Type of Use (Select one or both, as applicable)
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. To the left of the company name is a graphic of a square with a checkered pattern. The company name is in all caps and to the right of the name is the registered trademark symbol.
oration, 153 Shimokashiwano, Hakusan, Ishikawa
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 | Hiroaki Hashimoto |
|---|---|
| Department | Regulatory Compliance and |
| Safety | |
| Telephone | +81 (76) 274-2468 |
| hiroaki.hashimoto@eizo.com |
510(k) Summary K221136
1. Submitter
EIZO Corporation 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Japan Phone: +81 (76) 274-2468
Contact Person: Hiroaki Hashimoto Date of Prepared: April 14th, 2022
2. Device
- Name of Device: RadiForce MX243W
- Common or Usual Name: 61 cm (24.1 inch) class Color LCD Monitor
- Classification Name: Medical image management and processing system ● (21 CFR 892.2050) II
- Regulatory Class:
- Product Code: PGY
3. Predicate Device
- Name of Device: RadiForce MX242W (K143261) ●
- Common or Usual Name: 61 cm (24.1 inch) class Color LCD Monitor ●
- Classification Name: Medical image management and processing system (21 CFR 892.2050)
- Regulatory Class: II
- ● Product Code: PGY
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4. Device Description
RadiForce MX243W 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 1,920 x 1,200 pixels (2.3MP) with a pixel pitch of 0.270 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.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce MX243W 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 MX243W.
RadiCS is of Minor level of concern and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce MX243W and it's not a medical imaging software.
5. Indications for use
This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
5
6. Comparison of Technological Characteristics with the predicate device
The comparison table below enumerates information derived from the product brochure and measured values of the each device and different technological characteristics are discussed in it:
| Attributes | Proposed Device:
RadiForce MX243W | Predicate Device:
RadiForce MX242W |
|-------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display Technology | TFT Color
LCD Panel (IPS) | TFT Color
LCD Panel (IPS) |
| Screen size | 61cm / 24.1"
Aspect ratio: 16 : 10 | 61cm / 24.1"
Aspect ratio: 16 : 10 |
| Backlight type | LED | LED |
| Frame rate and refresh rate | | |
| Scanning Frequency
(H / V) | Digital: 31 - 76 kHz / 59 - 61 Hz
Frame synchronous mode: 59 - 61 Hz | Digital: 31 - 76 kHz / 59 - 61 Hz
(VGA Text: 69 - 71 Hz)
Frame synchronous mode: 59 - 61 Hz
Analog: 26 - 76 kHz / 49 - 71 Hz
(VGA Text: 69 - 71 Hz)
Frame synchronous mode: 59 - 61 Hz |
| Display Interface | | |
| Input video signals | DVI-D (single link) x 1,
DisplayPort x 1 | DVI-I x 1,
DisplayPort x 1 |
| Output video signals | DisplayPort x 1 (daisy chain) | - |
| Video bandwidth | DVI : 25-165 MHz
DisplayPort : 25 - 165 MHz | DVI-I (Analog): 25-165 MHz
DVI-I (Digital): 165MHz max.
DisplayPort: 165MHz max. |
| Ambient light sensing | | |
| Ambient light sensor | N/A | N/A |
| Luminance calibration tools | | |
| | Integrated optical sensor
External optical sensor
Calibration software:
RadiCS | Integrated optical sensor
External optical sensor
Calibration software:
RadiCS |
| Quality-control procedures | | |
| | Software: RadiCS | Software: RadiCS |
It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the MX243W.
6
7. Performance Testing
The bench tests below were performed on the RadiForce MX243W following the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on October 2, 2017:
- . Measurement of spatial resolution expressed as modulation transfer function (MTF)
- The maximum number allowed for each type of pixel defects/faults
- . Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline
- Measurement of temporal response
- Measurement of Luminance
- 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 pixel aperture ratio
- Measurement of Color tracking ●
The test results showed that the RadiForce MX243W has display characteristics equivalent to those of the predicate device, RadiForce MX242W.
Besides, the display characteristics of the RadiForce MX243W meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce MX243W.
8. Conclusion
The RadiForce MX243W 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.