(28 days)
Not Found
No
The description focuses on the hardware specifications of a medical display and quality control software, with no mention of AI or ML capabilities for image analysis or processing.
No
The device is a display monitor used for viewing radiological images for diagnosis, and it does not directly provide therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the product is "indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners." The term "diagnosis" clearly indicates that the device has a diagnostic function.
No
The primary device described is a color LCD monitor (RadiForce MX194), which is a hardware device. While the submission includes software (RadiCS) as an accessory, the core 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 radiological images for review, analysis, and diagnosis by trained medical practitioners." This describes a device used to visualize medical images, not a device used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis.
- Device Description: The description details a color LCD monitor designed for viewing medical images. It focuses on display technology, resolution, and calibration for image presentation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process related to testing specimens from the human body.
IVD devices are specifically designed to perform tests on biological samples to aid in diagnosis. This device is a display monitor, which is a tool used by medical professionals to interpret images generated by other diagnostic modalities (like X-ray, CT, MRI).
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 MX194 is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs Vertical Alignment (VA) technology allowing high contrast ratio and the matrix size (or resolution) is 1,280 x 1,024 pixels (1MP) with a pixel pitch of 0.294 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 MX194 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 MX194.
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 bench tests performed on the RadiForce MX194 following the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on October 2, 2017 included:
- 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 MX194 has display characteristics equivalent to those of the predicate device, RadiForce MX215. Besides, the display characteristics of the RadiForce MX194 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce MX194.
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
EIZO Corporation % Hiroaki Hashimoto Senior Manager 153 Shimokashiwano Hakusan, Ishikawa 924-8566 JAPAN
May 10, 2018
Re: K180961
Trade/Device Name: RadiForce MX194 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: April 10, 2018 Received: April 12, 2018
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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
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Page 2 - Hiroaki Hashimoto
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mechonl D. O'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
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Indications for Use
510(k) Number (if known) K180961
Device Name RadiForce MX194
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) |
|---|
| ------------------------------------------------- |
| Research Use (Per 21 CFR 201.128) or Screening Purposes |
|---|
| As Therapeutic Use (21 CFR part 312) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the EIZO logo. 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 a gray, three-dimensional object with a checkered pattern on its face. The "EIZO" text is in black, and there is a registered trademark symbol to the upper right of the letter "O".
EIZO Corporation, 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Janan
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 Requlatory Compliance and Safety
Telephone Fax E-Mail
+81 (76) 274-2468 +81 (76) 274-2484 hiroaki.hashimoto@eizo.com
510(k) Summary
1. Submitter
EIZO Corporation 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Japan Phone: +81 (76) 274-2468 Fax: +81 (76) 274-2484
Contact Person: Hiroaki Hashimoto Date of Prepared: April 10th, 2018
2. Device
- Name of Device: RadiForce MX194 ●
- Common or Usual Name: 48.1 cm (19.0 inch) class Color LCD Monitor ●
- Classification Name: Display, Diagnostic Radiology (21 CFR 892.2050) ●
- Regulatory Class: II
- Product Code: PGY
3. Predicate Device
EIZO Corporation RadiForce MX215 (K131090)
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4. Device Description
RadiForce MX194 is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs Vertical Alignment (VA) technology allowing high contrast ratio and the matrix size (or resolution) is 1,280 x 1,024 pixels (1MP) with a pixel pitch of 0.294 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 MX194 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 MX194.
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.
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6. Comparison of Technological Characteristics with the predicate device
The comparison table below enumerates information derived from the product brochure of the each device and different technological characteristics are discussed in it:
| Attributes | Proposed Device:
RadiForce MX194 | Predicate Device:
RadiForce MX215 |
|---------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Display Technology | TFT Color
LCD Panel (VA) | TFT Color
LCD Panel (IPS) |
| Screen size | 48.1cm / 19.0"
Aspect ratio: 5 : 4 | 54cm / 21.3"
Aspect ratio: 3 : 4 |
| Backlight type | LED | LED |
| Frame rate and refresh rate | | |
| Digital Scanning Frequency
(H / V) | 31 - 64 kHz / 59 - 61 Hz | 31 - 100 kHz / 59 - 61 Hz |
| Analog Scanning Frequency
(H / V) | 24.8 - 80 kHz / 50 - 75 Hz | 26 - 100 kHz / 49 - 76 Hz |
| Display Interface | | |
| Input video signals | DVI-D x 1,
DisplayPort x 1,
D-Sub mini 15 pin x 1 | DVI-I x 1,
DisplayPort x 1 |
| Video bandwidth | | |
| | DVI : 108MHz
DisplayPort : 108MHz
Analog : 135MHz | DVI : 164.5MHz
DisplayPort : 164.5MHz
Analog : 164.5MHz |
| Ambient light sensing | | |
| Ambient light sensor | Yes | Yes |
| 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 MX194.
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7. Performance Testing
The bench tests below were performed on the RadiForce MX194 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 Color tracking
The test results showed that the RadiForce MX194 has display characteristics equivalent to those of the predicate device, RadiForce MX215.
Besides, the display characteristics of the RadiForce MX194 meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce MX194.
8. Conclusion
The RadiForce MX194 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.