(60 days)
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.
No
The device is a monitor for displaying radiological images for diagnosis, and does not directly provide therapy or interact with the patient in a therapeutic manner.
Yes
The device is indicated for use in "displaying radiological images for review, analysis, and diagnosis," and specifically mentions its use by "trained medical practitioners" for "diagnosis," which are hallmarks of a diagnostic device. The included software, RadiCS, is for "quality control of the diagnostic monitors."
No
The primary device described is a color LCD monitor (RadiForce MX217), which is a hardware device. While the submission includes software (RadiCS) as an accessory, the core device for which the 510(k) is submitted is hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The RadiForce MX217 is a display monitor used for viewing radiological images. It processes and displays images that have already been acquired from a patient's body (e.g., X-rays, CT scans, MRI scans). It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for "displaying radiological images for review, analysis, and diagnosis." This is related to medical imaging, not in vitro testing.
The device is a medical device, specifically a display device for diagnostic radiology, but it falls under a different regulatory category than IVDs.
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
PGY
Device Description
RadiForce MX217 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) 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 MX217 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 MX217.
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 MX217 and it's not a medical imaging software.
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 bench tests below were performed on the RadiForce MX217 following the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on September 28,2022:
- 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 Color tracking
The test results showed that the RadiForce MX217 has display characteristics equivalent to those of the predicate device, RadiForce MX216.
Besides, the display characteristics of the RadiForce MX217 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce MX217.
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 contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
EIZO Corporation % Hiroaki Hashimoto Senior Manager 153 Shimokashiwano Hakusan, Ishikawa 924-8566 JAPAN
Re: K230684
May 12, 2023
Trade/Device Name: RadiForce MX217 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: March 13, 2023 Received: March 13, 2023
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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- 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
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) K230684
Device Name RadiForce MX217
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K230684
Image /page/3/Picture/1 description: The image shows the logo for EIZO. The logo consists of a stylized, geometric shape on the left and the word "EIZO" in bold, sans-serif font on the right. The geometric shape is composed of squares and triangles, creating a textured, three-dimensional effect. A small registered trademark symbol is located to the upper right of the letter "O" in "EIZO".
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 | Hiroaki Hashimoto |
|---|---|
| Department | Regulatory Compliance and |
| Safety | |
| Telephone | +81 (76) 274-2468 |
| hiroaki.hashimoto@eizo.com |
510(k) Summary
1. Submitter
EIZO Corporation 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Japan Phone: +81 (76) 274-2468
Contact Person: Hiroaki Hashimoto Date of Prepared: March 13th, 2023
2. Device
- Name of Device: RadiForce MX217
- Common or Usual Name: 21.3 inch (54.0 cm) 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 MX216 (K190153) ●
- Common or Usual Name: 54.1 cm (21.3 inch) class Color LCD Monitor ●
- . Classification Name: Picture archiving and communications system (21 CFR 892.2050)
- II
- Regulatory Class: PGY . Product Code:
4
4. Device Description
RadiForce MX217 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) 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 MX217 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 MX217.
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 MX217 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 MX217 | Predicate Device:
RadiForce MX216 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. |
| Display Technology | TFT Color
LCD Panel (IPS) | TFT Color
LCD Panel (IPS) |
| Screen size | 54.0cm / 21.3"
Aspect ratio: 3 : 4 | 54.0cm / 21.3"
Aspect ratio: 3 : 4 |
| Backlight type | LED | LED |
| Frame rate and refresh rate | | |
| Digital Scanning Frequency
(H / V) | 31 - 100 kHz / 59 - 61 Hz | 31 - 100 kHz / 59 - 61 Hz |
| Display Interface | | |
| Input video signals | DVI-D x 1,
DisplayPort x 1 | DVI-D x 1,
DisplayPort x 1 |
| Output video signals | DisplayPort x 1 (daisy chain) | DisplayPort x 1 (daisy chain) |
| Video bandwidth | | |
| | DVI : 25-164.5MHz
DisplayPort : 25-164.5MHz | DVI : 164.5MHz
DisplayPort : 164.5MHz |
| Ambient light sensing | | |
| Ambient light sensor | Photo Diode
Position: In the upper bezel of the
screen
Software tool: RadiCS | Photo Diode
Position: In the upper bezel of the
screen
Software tool: RadiCS |
| 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 |
6
It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the MX217.
7. Performance Testing
The bench tests below were performed on the RadiForce MX217 following the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on September 28,2022:
- 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 Color tracking
The test results showed that the RadiForce MX217 has display characteristics equivalent to those of the predicate device, RadiForce MX216.
Besides, the display characteristics of the RadiForce MX217 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce MX217.
8. Conclusion
The RadiForce MX217 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.