(30 days)
Not Found
No
The document describes a medical monitor with features for image display and quality control, but there is no mention of AI or ML technology being used for image analysis, processing, or any other function.
No
Explanation: The device is a display monitor intended for displaying medical images for diagnosis. It does not exert any direct therapeutic action on a patient.
No
This device is a monitor used for displaying medical images for diagnosis, not for performing the diagnosis itself. Its function is to present images faithfully along DICOM GSDF, ensuring luminance stability and uniformity, which are crucial for accurate image interpretation by medical practitioners, but it does not analyze or interpret the images to make a diagnosis.
No
The device description clearly describes a physical hardware component (a 21.3 inch Monochrome Digital Mammography LCD Monitor) with specific hardware features and functions.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body (in vitro).
- Device Function: The MS-S300 is a medical image display monitor. Its purpose is to display images generated by other medical devices (like mammography machines) for interpretation by medical professionals. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for "displaying medical images for diagnosis." This aligns with the function of a display device, not an IVD.
Therefore, based on the provided information, the MS-S300 is a medical device, but it falls under the category of a medical image display monitor, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
MS-S300 is intended to be used in displaying medical images for diagnosis by trained medical practitioners or certified personnel. It's intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
21.3 inch Monochrome Digital Mammography LCD Monitor
2048 x 1536 (landscape), 1536 x 2048 (portrait)
■ High-luminance monochrome LCD panel, which has wide view
angle, is used for this product. It is designed for medical image
display.
■ Luminance stabilization function composed with luminance
sensor and luminance control circuit always observes the
luminance and makes it stable.
■ Images are faithfully displayed along grayscale characteristics
(DICOM GSDF) based on the calibrated data stored to the lookup
table of the monitor.
■ It minimizes luminance unevenness by Uniformity Correction
Function to achieve the uniformity of luminance on the whole
screen.
■ Quantitative evaluation and visual evaluation are done before
the shipment. Quality control along the QC guideline is conducted.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners or certified personnel.
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)
Recommended Physical Laboratory Tests:
a. Spatial resolution - MTF measurement method that uses a bar-pattern image. (Rectangle chart method)
b. Pixel defects (maximum counts, allowed defect types, and locations) - ISO13406-2 and Flat Panel Display Measurement Standard [VESA 2001] were used.
c. Artifacts - Artifacts (phase or clock, ringing, ghosting, image sticking, etc.)
d. Temporal response - JVCKENWOOD uses typical data provided by the panel manufacturer. (5-95%, 10-90%, 40-60%)
e. Luminance (maximum, minimum, achievable, and recommended) - Lmin, and Lmax on the calibrated luminance was confirmed by the requirement of the "Luminance Response" test of AAPM-TG18.
f. Conformance to a grayscale-to-luminance function (e.g., DICOM GSDF) - Luminance Response at 256 digital values by AAPM-TG18
g. Luminance at 30° and 45° in diagonal, horizontal, and vertical directions at center and four corners - Angular dependency of luminance by AAPM-TG18
h. Luminance uniformity or Mura test - Luminance Uniformity by AAPM-TG18 Chromaticity by AAPM-TG18
i. Stability of luminance and chromaticity response with temperature and time of operation or on-time - 0°C, 25°C, and 40°C on Luminance response by AAPM-TG18 (Power On Drift.)
j. Spatial noise - Noise Power Spectrum
k. Reflection coefficient - Specular reflection and Diffuse reflection by AAPM-TG18
I. Veiling glare or small-spot contrast - Veiling Glare test by AAPM-TG18
Other - Pixel fill factor (Pixel structure and aperture ratio of pixel.
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.
MS35i2/ K133686
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). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
February 21, 2020
JVCKENWOOD Corporation % Hideki Tengeiji Senior Manager 3-12, Moriya-cho, Kanagawa-ku Yokohama, Kanagawa 221-0022 JAPAN
Re: K200161
Trade/Device Name: 3MP Monochrome Digital Mammography LCD Monitor MS-S300 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: January 16, 2020 Received: January 22, 2020
Dear Hideki Tengeiji:
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
1
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) 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 (OS) 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,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
3MP Monochrome Digital Mammography LCD Monitor MS-S300
Indications for Use (Describe)
MS-S300 is intended to be used in displaying medical images for diagnosis by trained medical practitioners or certified personnel. It's intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
3
JVCKENWOOD
510(k) SUMMARY K200161
| Submitted Information: | JVCKENWOOD Corporation
3-12, Moriya-cho, Kanagawa-ku,
Yokohama-shi, Kanagawa, 221-0022 Japan | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Hideki Tengeiji, Senior Manager
Email: tengeiji.hideki@jvckenwood.com
Tel: +81-45-450-2715
Fax: +81-45-450-1926 | |
| Date Prepared: | January 16, 2020 | |
| Device Name: | 3MP Monochrome Digital Mammography LCD Monitor MS-S300 | |
| Common Name: | MS-S300 (MS-S300xxxxx) | |
| Classification Name: | Class II
(Part 892 Radiology Devices
Sec. 892.2050 Picture Archiving and Communication System) | |
| Predicate Device: | 21.3 inch (54cm) Monochrome LCD Monitor MS35i2
(MS35i2/ K133686) | |
| Device Description: | 21.3 inch Monochrome Digital Mammography LCD Monitor
2048 x 1536 (landscape), 1536 x 2048 (portrait)
■ High-luminance monochrome LCD panel, which has wide view
angle, is used for this product. It is designed for medical image
display.
■ Luminance stabilization function composed with luminance
sensor and luminance control circuit always observes the
luminance and makes it stable.
■ Images are faithfully displayed along grayscale characteristics
(DICOM GSDF) based on the calibrated data stored to the lookup
table of the monitor.
■ It minimizes luminance unevenness by Uniformity Correction
Function to achieve the uniformity of luminance on the whole
screen.
■ Quantitative evaluation and visual evaluation are done before
the shipment. Quality control along the QC guideline is conducted. | |
4
JVCKENWOOD
- MS-S300 is intended to be used in displaying and viewing medical Intended Use: images for diagnosis by trained medical practitioners or certified personnel. lt's intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
- MS-S300 shares the same technical characteristics, application, and Substantial Equivalence: intended use as our predicate device MS35i2/ K133686.
MS-S300 is substantially equivalent to the predicate device with Conclusion: respect to technical characteristics, application and intended use. The specification of the primary component employed by the proposed device is the same as one of the predicate device, and other differences have been independently validated. Any differences between the devices do not affect safety or effectiveness.
JVCKENWOOD Corporation Healthcare Business Division 3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi, Kanagawa, 221-0022 Japan
5
Substantial Equivalence Comparison
This comparison table shows the differences on the technical characteristics between the proposed device and the predicate device.
| | Predicate device
LCD Monitor MS35i2
(ML21035) | LCD Monitor MS-S300 | Explanation of
Differences |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| 510(k) Number | K133686 | — | — |
| Indication for Use | MS35i2 is intended to be used in
displaying and viewing medical images for
diagnosis by trained medical practitioners
or certified personnel. It is to be used in
digital mammography PACS and
modalities including FFDM. | MS-S300 is intended to be used in
displaying and viewing medical images for
diagnosis by trained medical practitioners
or certified personnel. It is intended to be
used in digital mammography PACS,
digital breast tomosynthesis and modalities
including FFDM. | — |
| Response Time
(typical) | 40ms (On/Off) | 28ms (On/Off) | Response Time of MS-S300 is better
than the predicate's one. |
| Resolution or
Matrix Size | 3MP(1536 x 2048) | 3MP(1536 x 2048) | — |
| Screen Technology | TFT Monochrome LCD Panel (IPS) | TFT Monochrome LCD Panel (IPS) | — |
| Backlighting | LED | LED | — |
| Maximum Luminance | Typ. 1700cd/m2 | Typ. 2000cd/m2 | The maximum luminance of MS-S300
is much better than the predicate's one. |
| DICOM
Calibrated Luminance | 500cd/m2 | 500cd/m2 | — |
| Viewing Angle | CR>10
Horizontal: Typ.176
Vertical: Typ.176 | CR>10
Horizontal: Typ.178
Vertical: Typ.178 | Viewing angle of MS-S300 is wider
than the predicate's one. |
| Display Area | Horizontal: 324.86mm
Vertical: 433.15mm | Horizontal: 324.86mm
Vertical: 433.15mm | — |
| Aspect Ratio | 3:4 | 3:4 | — |
| Pixel Pitch | Horizontal: 0.2115mm
Vertical: 0.2115mm | Horizontal: 0.2115mm
Vertical: 0.2115mm | — |
| Contrast Ratio | Typ. 1400:1 | Typ. 1500:1 | Contrast ratio of MS-S300 is wider than the predicate's one |
| Grayscale Tones | 10.3 bit: (1276 gradation) | 10.3 bit: (1276 gradation) | — |
| Non-Uniformity
Compensation | Digital Uniformity Correction System | Digital Uniformity Correction System | — |
| Input Video Signal | DVI-D x1
DisplayPort x1 | DVI-D x1
DisplayPort x1 | — |
| Scanning Frequency | DVI
46.6KHz, Vertical: 30Hz (Landscape)
61.9KHz, Vertical: 30Hz (Portrait)
93.1KHz, Vertical: 60Hz (Landscape)
123.9KHz, Vertical: 60Hz (Portrait)
DisplayPort
47.4KHz, Vertical: 30Hz (Landscape)
63.2KHz, Vertical: 30Hz (Portrait)
94.8KHz, Vertical: 60Hz (Landscape)
126.3KHz, Vertical: 60Hz (Portrait) | DVI
46.6KHz, Vertical: 30Hz (Landscape)
61.9KHz, Vertical: 30Hz (Portrait)
93.1KHz, Vertical: 60Hz (Landscape)
123.9KHz, Vertical: 60Hz (Portrait)
DisplayPort
47.4KHz, Vertical: 30Hz (Landscape)
63.2KHz, Vertical: 30Hz (Portrait)
94.8KHz, Vertical: 60Hz (Landscape)
126.3KHz, Vertical: 60Hz (Portrait) | — |
| Dot Clock | 216 MHz | 216 MHz | — |
| Power Requirements | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz | — |
| Power Consumption | 60W
Less than 2W | 55W
Less than 2W | Power consumption on MS-S300 is less than the predicate's one. |
| Power Management | DVI DMPM,
DisplayPort 1.1a | DVI DMPM,
DisplayPort 1.2a | — |
| QA Software | Medivisor NX
F-CAL | QA Medivisor Agent
F-CAL | "QA Medivosior Agent" is the later software of "Medivisor NX". |
| Sensor | Built- in Front Sensor
Built-in ambient Light Sensor | Built-in front sensor
Built-in ambient light sensor
Built-in human presence sensor | Used for the power save function. |
| USB Ports / Standard | 1 upstream,
2 downstream / Rev. 2.0 | 1 upstream,
2 downstream / Rev. 2.0 | — |
| Dimensions with Stand
(W x H x D) | 367.0 x 522/583 x 220.0 mm | 361.5 x 517.0 / 612.0 x 196.5 mm | — |
6
7
Recommended Physical Laboratory Tests
| Measurements
Guidance | MS-S300
Measurements |
|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| a. Spatial resolution | MTF measurement method that uses a bar-pattern
image.
(Rectangle chart method) |
| b. Pixel defects
(maximum counts, allowed defect
types, and locations) | ISO13406-2 and Flat Panel Display Measurement
Standard [VESA 2001] were used. |
| c. Artifacts | Artifacts (phase or clock, ringing, ghosting, image
sticking, etc.) |
| d. Temporal response | JVCKENWOOD uses typical data provided by the
panel manufacturer.
(5-95%, 10-90%, 40-60%) |
| e. Luminance
(maximum, minimum, achievable,
and recommended) | Lmin, and Lmax on the calibrated luminance was
confirmed by the requirement of the "Luminance
Response" test of AAPM-TG18. |
| f. Conformance to a grayscale-to-
luminance function
(e.g., DICOM GSDF) | Luminance Response at 256 digital values by
AAPM-TG18 |
| g. Luminance at 30° and 45° in
diagonal, horizontal, and vertical
directions at center and four
corners | Angular dependency of luminance by AAPM-TG18 |
| h. Luminance uniformity or Mura
test | Luminance Uniformity by AAPM-TG18
Chromaticity by AAPM-TG18 |
| i. Stability of luminance and
chromaticity response with
temperature and time of operation
or on-time | 0°C, 25°C, and 40°C on Luminance response by
AAPM-TG18
(Power On Drift.) |
| j. Spatial noise | Noise Power Spectrum |
| k. Reflection coefficient | Specular reflection and Diffuse reflection by
AAPM-TG18 |
| I. Veiling glare or small-spot
contrast | Veiling Glare test by AAPM-TG18 |
| Other | Pixel fill factor
(Pixel structure and aperture ratio of pixel. |