(18 days)
No
The document describes a medical display monitor and does not mention any AI or ML capabilities for image processing or analysis.
No
The device is a monitor used for displaying and viewing medical images for diagnosis, not for providing therapy or treatment.
No
The device is a monitor used for displaying medical images, which are then used by practitioners for diagnosis. The monitor itself does not perform the diagnostic function.
No
The device description explicitly states it is a 21.3-inch LCD monitor, which is a hardware component.
Based on the provided information, 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 description clearly states that this device is a monitor intended for displaying and viewing medical images. It does not perform any tests on biological samples.
- Intended Use: The intended use is for displaying images from digital mammography PACS and modalities, which are imaging systems, not IVD tests.
Therefore, this device falls under the category of medical imaging display devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) and 5MP Color LCD Monitor CCL550i2 (CL21550) are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. They are to be used in digital mammography PACS, modalities including FFDM, and breast tomosynthensis
Product codes
PGY
Device Description
MS55i2 (ML21055, MD211G5) is a 21.3 inch (54 cm) monochrome LCD monitor and CCL550i2 (CL21550) is a 21.3 inch (54 cm) color LCD monitor. Their displays' resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface) and DisplayPort.
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
Not Found
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).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the smallest and the bottom profile being the largest.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2016
JVC KENWOOD Corporation % Mr. Tsukasa Tashiro Engineering Specialist 3-12, Moriya-cho, Kanagawa-ku Yokohama, Kanagawa 221-0022 JAPAN
Re: K160326
Trade/Device Name: 5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) 5MP Color LCD Monitor CCL550i2 (CL21550) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: January 29, 2016 Received: February 5, 2016
Dear Mr. Tashiro:
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
1
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. 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,
Robert Ocks
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K160326
Device Name
5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) 5MP Color LCD Monitor CCL550i2 (CL21550)
Indications for Use (Describe)
5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) and
5MP Color LCD Monitor CCL550i2 (CL21550)
are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. They are to be used in digital mammography PACS, modalities including FFDM, and breast tomosynthensis
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 Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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."
Form Approved: OMB No. 0910-0120
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Image /page/3/Picture/0 description: The image shows the logo for JVC KENWOOD. The logo is in a dark blue color. Below the logo is the text "creates excitement & peace of mind" in a light blue color.
510(k) SUMMARY
| Submitted Information: | JVC KENWOOD Corporation
3-12, Moriya-cho, Kanagawa-ku,
Yokohama-shi, Kanagawa, 221-0022 Japan | | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Tsukasa Tashiro, Engineering Specialist
Email: tashiro.tsukasa@jvckenwood.com
Tel: +81-258-24-6611
Fax: +81-258-24-6617 | | |
| Date Prepared: | January 29, 2016 | | |
| Device Name: | 1. 5MP Monochrome LCD Monitor MS55i2
(ML21055, MD211G5)
2. 5MP Color LCD Monitor CCL550i2
(CL21550) | | |
| Common Name: | 1. MS55i2 (ML21055, MD211G5)
2. CCL550i2 (CL21550) | | |
| Classification Name: | Class II
(Part 892 Radiology Devices
Sec. 892.2050 Picture Archiving and Communication System) | | |
| Predicate Device: | 5MP Monochrome LCD Monitor, RadiForce GX540 (K151883) | | |
| Device Description: | MS55i2 (ML21055, MD211G5) is a 21.3 inch (54 cm) monochrome
LCD monitor and CCL550i2 (CL21550) is a 21.3 inch (54 cm) color
LCD monitor. Their displays' resolution is 2048 x 2560 (landscape),
2560 x 2048 (portrait) supporting DVI (digital visual interface) and
DisplayPort. | | |
| Intended Use: | 5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) and
5MP Color LCD Monitor CCL550i2 (CL21550)
are intended to be used in displaying and viewing medical images
for diagnosis by trained medical practitioners.
They are to be used in digital mammography PACS, modalities
including FFDM, and breast tomosynthensis | | |
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Image /page/4/Picture/0 description: The image shows the JVC KENWOOD logo in dark blue. Below the logo is the text "creates excitement & peace of mind" in a lighter blue color. The logo is simple and modern, with a focus on the company's name and tagline.
510(k) SUMMARY
Substantial Equivalence:
LCD Monitor MS55i2(ML21055, MD211G5)
| | EIZO RadiForce GX540 | LCD Monitor MS55i2
(ML21055, MD211G5) | Explanation of
Differences |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K151883 | K131137 | JVC KENWOOD uses
typical data provided by the
panel
manufacturer.
For further explanation
refer to temporal response
of MS55i2. |
| Response Time
(typical) | 25ms (On/Off) | 25ms (On/Off) | |
| Resolution or
Matrix Size | 5MP(2048 x 2560) | 5MP(2048 x 2560) | - |
| Screen
Technology | TFT Monochrome
LCD Panel (IPS) | TFT Monochrome
LCD Panel (IPS) | - |
| Backlighting | LED | LED | - |
| Maximum
Luminance | Min.850cd/m²
Typ.1200cd/m². | Min.850cd/m²
Typ.1200cd/m². | - |
| DICOM
Calibrated
Luminance | 500cd/m² | 500cd/m² | - |
| Viewing Angle | CR>50
Horizontal: Typ.176
Vertical: Typ.176 | CR>50
Horizontal: Typ.176
Vertical: Typ.176 | - |
| Display Area | Horizontal: 337.92mm
Vertical: 422.4mm | Horizontal: 337.92mm
Vertical: 422.4mm | - |
| Aspect Ratio | 4:5 | 4:5 | - |
| Pixel Pitch | Horizontal: 0.165mm
Vertical: 0.165mm | Horizontal: 0.165mm
Vertical: 0.165mm | - |
| Contrast Ratio | Min.900 : 1
Typ.1200 : 1 | Min.900 : 1
Typ.1200 : 1 | - |
| Grayscale
Tones | 10-bit (DisplayPort): 1,024
from a palette of 16,369
tones
8-bit: 256 from a palette of
16,369 tones | 10-bit (DisplayPort): 1,024
from a palette of 12,277 tones
8-bit: 256 from a palette of
12,277 tones | Maximum bit depth by
Display port is 10 bit, it by
DVI is 8 bit.
Tone between the predicated
device and our monitors are
different. But our monitors
pass the exams in
AAPM-TG18 4.3
"Luminance Response".
Our monitors are equivalent
to the predicated device |
| Non-Uniformity
Compensation | Digital Uniformity
Equalizer (DUE) | Digital Uniformity correction
System | Our Uniformity
correction system is
equivalent to the
predicated device's one.
This system is helpful to
make visual performance
much better in the point
of luminance
(monochrome and color
version) and chromaticity. |
| Input Video Signal | DVI-D x1
DisplayPort x1 | DVI-D x1
DisplayPort x1 | - |
| Scanning
Frequency | 31 - 135 kHz / 24 - 61 Hz
Frame synchronous
mode: 24.5 - 25.5 Hz, 49
- 51 Hz | Portrait:
Horizontal:129.1KHz
Vertical:50Hz
Landscape:
Horizontal:103.5KHz | JVC KENWOOD specifies
only maximum scanning
frequency which is based on
the LCD panel driving
specification. |
| | | Vertical:50Hz | |
| Dot Clock | 290MHz | 285 MHz | JVC KENWOOD specifies
the dot clock which is based
on the LCD panel driving
specification. |
| | | | |
| Power
Requirements | AC 100 - 120 V,
200 - 240 V: 50 / 60 Hz | AC100-240V, 50/60Hz | JVC KENWOOD
specification covers power
requirement specification of
the predicated device. |
| Power | 108 W | 80W | - |
| Consumption | Less than 0.7 W | Less than 2W | - |
| Power | DVI DMPM, | DVI DMPM, | - |
| Management | DisplayPort 1.1a | DisplayPort 1.1a | - |
| | | | |
| QA Software | RadiCS | QA Medivisor / Medivisor NX
F-CAL | - |
| Sensor | Integrated Front Sensor
(IFS) | Built- in Front Sensor | - |
| | Backlight Sensor (BS) | None | Brightness stability is
controlled by the built-in
Front sensor. |
| | Ambient Light Sensor
(ALS) | Built-in ambient Light Sensor | - |
| | Presence Sensor (PS) | None | - |
| | | | |
| USB Ports /
Standard | 1 upstream,
2 downstream / Rev. 2.0 | 1 upstream,
2 downstream / Rev. 2.0 | - |
| Dimensions
w/o Stand
(W x H x D) | 388 x 496 x 99 mm | (AR, N) 474.5 x 390 x 98.1 mm
(F) 474.5 x 390 x 103.7 mm | - |
| | EIZO RadiForce GX540 | LCD Monitor CCL550i2
(CL21550) | Explanation of Differences |
| 510(k) Number | K151883 | K151007 | - |
| Response Time
(typical) | 25ms (On/Off) | 25ms (On/Off) | JVC KENWOOD uses typical data provided by the panel manufacturer.
For further explanation refer to temporal response of CCL550i2 |
| Resolution or
Matrix Size | 5MP(2048 x 2560) | 5MP(2048 x 2560) | - |
| Screen
Technology | TFT Monochrome LCD Panel (IPS) | TFT Color LCD Panel (IPS) | - |
| Backlighting | LED | LED | - |
| Maximum
Luminance | Min.850cd/m2
Typ.1200cd/m2. | Min.700cd/m2
Typ. 1000cd/m2 | Maximum luminance of color model is lower than monochrome panel.
However DICOM Calibrated luminance is same as the predicated device. |
| DICOM
Calibrated
Luminance | 500cd/m2 | 500cd/m2 | Then actual performance for diagnosis is the same. |
| Viewing Angle | CR>50
Horizontal: Typ.176
Vertical: Typ.176 | CR>50
Horizontal: Typ.176
Vertical: Typ.176 | - |
| Display Area | Horizontal: 337.92mm
Vertical: 422.4mm | Horizontal: 337.92mm
Vertical: 422.4mm | - |
| Aspect Ratio | 4:5 | 4:5 | - |
| Pixel Pitch | Horizontal: 0.165mm
Vertical: 0.165mm | Horizontal: 0.165mm
Vertical: 0.165mm | - |
| Contrast Ratio | Min.900 : 1
Typ.1200 : 1 | Min.1000 : 1
Typ. 1300 : 1 | Contrast ratio of the color model is higher than the monochrome model. |
| Grayscale
Tones | 10-bit (DisplayPort): 1,024 from a palette of 16,369 tones
8-bit: 256 from a palette of 16,369 tones | 10-bit (DisplayPort): 1,024 from a palette of 65,473 tones
8-bit: 256 from a palette of 65,473 tones | Maximum bit depth by Display port is 10 bit, it by DVI is 8 bit.
Tone between the predicated device and our monitors are different. But our monitors pass the exams in AAPM-TG18 4.3 "Luminance Response".
Our monitors are equivalent to the predicated device |
| Non-Uniformity
Compensation | Digital Uniformity Equalizer (DUE) | Digital Uniformity correction System | Our Uniformity correction system is equivalent to the predicated device's one.
This system is helpful to make visual performance much better in the point of luminance (monochrome and color version) and chromaticity. |
| Input Video Signal | DVI-D x1
DisplayPort x1 | DVI-D x1
DisplayPort x1 | - |
| Scanning
Frequency | 31 - 135 kHz / 24 - 61 Hz
Frame synchronous mode: 24.5 - 25.5 Hz, 49 - 51 Hz | Portrait:
Horizontal: 129.1 KHz
Vertical: 50Hz
Landscape:
Horizontal: 103.5 KHz
Vertical: 50Hz | JVC KENWOOD specifies only maximum scanning frequency which is based on the LCD panel driving specification. |
| Dot Clock | 290MHz | 285 MHz | JVC KENWOOD specifies the dot clock which is based on the LCD panel driving specification. |
| Power
Requirements | AC 100 - 120 V,
200 - 240 V: 50 / 60 Hz | AC100-240V, 50/60Hz | JVC KENWOOD
specification covers power
requirement specification of
the predicated device. |
| Power | 108 W | 95W | - |
| Consumption | Less than 0.7 W | Less than 2W | - |
| Power | DVI DMPM, | DVI DMPM, | - |
| Management | DisplayPort 1.1a | DisplayPort 1.1a | - |
| QA Software | RadiCS | QA Medivisor / Medivisor NX
F-CAL | - |
| Sensor | Integrated Front Sensor
(IFS) | Built- in Front Sensor | - |
| | Backlight Sensor (BS) | None | Brightness stability is
controlled by the built-in
Front sensor. |
| | Ambient Light Sensor
(ALS) | Built-in ambient Light Sensor | - |
| | Presence Sensor (PS) | None | - |
| USB Ports / | 1 upstream, | 1 upstream, | - |
| Standard | 2 downstream / Rev. 2.0 | 2 downstream / Rev. 2.0 | - |
| Dimensions
w/o Stand
(W x H x D) | 388 x 496 x 99 mm | (AR, N) 474.5 x 390 x 98.1 mm
(F) 474.5 x 390 x 103.7 mm | - |
5
MS55i2 adopts exactly the same panel as the predicated device, therefore its specification is completely same as the predicated device
6
7
Maximum luminance of the CCL550i2-panel is low, but calibrated luminance at the time of factory shipment state is 500cd/m2.
This value is same as the predicated one. Moreover, contrast ratio of CCL550i2-panel is better, and other specifications in comparison items are similar. Therefore, our monitor is equivalent to the predicated device.
JVC KENWOOD Corporation Professional & Healthcare Division
3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi, Kanagawa, 221-0022 Japan