(77 days)
Not Found
No
The description focuses on display technology, calibration, and quality control, with no mention of AI or ML algorithms for image analysis or processing beyond standard display functions.
No
The device is a monitor used for displaying and viewing medical images for diagnosis, not for treating any condition or disease.
No
The device is a medical monitor intended for displaying and viewing medical images for diagnosis, and while crucial for diagnosis, it is not performing the diagnostic process itself.
No
The device description clearly states it is a "21.3 inch (54cm) Monochrome LCD Monitor" and details hardware components like the LCD panel, luminance sensor, and control circuit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "displaying and viewing medical images for diagnosis." This involves presenting visual information to a medical professional for interpretation, not performing tests on biological samples.
- Device Description: The description focuses on the technical specifications of a medical monitor designed for displaying images with specific characteristics (monochrome, high luminance, DICOM GSDF compliance, uniformity correction). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing results based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a display tool for medical images, which are typically generated by other medical devices (like X-ray machines, CT scanners, MRI machines, etc.).
N/A
Intended Use / Indications for Use
MS-S200 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
Product codes
PGY
Device Description
2MP Monochrome LCD Monitor MS-S200
21.3 inch (54cm) Monochrome LCD Monitor
1600 x1200 (landscape)
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
Not Found
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)
Validation for Performance Specification: All items in monitor specification have met the acceptance criteria according to the standard, AAPM-TG18 and ISO 13406-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MS25i2 (ML21025) (MS25i2/ K133511)
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
April 23, 2021
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Jvckenwood Corporation % Hideki Tengeiji Senior Manager 3-12, Moriya-cho, Kanagawa-ku Yokohama-shi, Kanagawa 221-0022 JAPAN
Re: K210345
Trade/Device Name: 2MP Monochrome LCD Monitor MS-S200 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: January 29, 2021 Received: February 5, 2021
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 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
1
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.
For
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
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Indications for Use
510(k) Number (if known) K210345
Device Name 2MP Monochrome LCD Monitor MS-S200
Indications for Use (Describe)
MS-S200 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital 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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3
JVCKENWOO DID
510(k) SUMMARY
| 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: | April 13, 2021 |
| Device Name: | 2MP Monochrome LCD Monitor MS-S200 |
| Common Name: | MS-S200
(MS-S200xxxxx) |
| 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 MS25i2 (ML21025)
(MS25i2/ K133511) |
| Device Description: | 21.3 inch (54cm) Monochrome LCD Monitor
1600 x1200 (landscape) |
| | 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. |
| Intended Use: | MS-S200 is intended to be used in displaying and viewing medical
images for diagnosis by trained medical practitioners or certified
personnel.
It is not meant to be used in digital mammography. |
| Substantial Equivalence: | MS-S200 shares the same technical characteristics, application, and
intended use as our predicate device MS25i2/K133511. |
| Validation for Performance
Specification: | All items in monitor specification have met the acceptance criteria
according to the standard, AAPM-TG18 and ISO 13406-2. |
| Changes in the new
monitor, MS-S200: | 1) Response Time
19 ms (new monitor:MS-S200) vs. 40 ms (predicate device:MS25i2)
The specification of the proposed device (MS-S200) is superior to that of
the predicate device (MS25i2).
2) Contrast Ratio
1800:1 (new monitor:MS-S200) vs. 1400:1 (predicate device:MS25i2)
The specification of the proposed monitor (MS-S200) is superior to that
of the predicate device (MS25i2) |
| Conclusion: | Based on our specification confirmation and physical evaluation as
above, the proposed device is substantial equivalent to the predicate |
4
JVCKENWOOD
device.
JVCKENWOOD Corporation
Healthcare Business Division
5
Substantial Equivalence Comparison
| | Predicate Device
MS25i2 (ML21025) | Proposed Device
MS-S200 (MS-S200xxxxx) | Explanation of
Differences | Response Time (typical) | T on + T off (10%-90%)
40 ms typ. | T on + T off (10%-90%)
19 ms typ. | The specification of the
proposed device is
superior to that of the
predicate device. |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| 510(k) Number | K133511 | Not Known | — | Aspect Ratio | 3:4 | 3:4 | – |
| Indication for Use | 21.3 inch (54 cm) Monochrome 2M pixel LCD
Monitor MS25i2 (ML21025) is intended to be
used in displaying and viewing medical images
for diagnosis by trained medical practitioners or
certified personnel.
It is not meant to be used in digital
mammography. | 21.3 inch (54 cm) Monochrome 2M pixel LCD
Monitor MS-S200 (MS-S200xxxxx) is
intended to be used in displaying and viewing
medical images for diagnosis by trained
medical practitioners or certified personnel.
It is not meant to be used in digital
mammography. | — | Pixel Pitch | Horizontal: 0.270 mm, Vertical: 0.270 mm | Horizontal: 0.270 mm, Vertical: 0.270 mm | – |
| Resolution or Matrix Size | Portrait : 1200 x 1600 (4800 subpixel)
Landscape : 1600 (4800 subpixel) x 1200 | Portrait : 1200 x 1600 (4800 subpixel)
Landscape : 1600 (4800 subpixel) x 1200 | — | Contrast Ratio | 1400:1 | 1800:1 | The specification of the
proposed device is
superior to that of the
predicate device. |
| Screen Technology | TFT Monochrome LCD Panel (IPS) | TFT Monochrome LCD Panel (IPS) | — | Grayscale Tones | 10.3 bit (1276 gradation) | 10.3 bit (1276 gradation) | – |
| Backlighting | LED | LED | — | Non-Uniformity
Compensation | N/A | N/A | – |
| Maximum Luminance | 1900 cd/m² typ. | 1900 cd/m² typ. | — | Input Video Signal | DVI-D, DisplayPort | DVI-D, DisplayPort | – |
| DICOM
Calibrated Luminance | 0.8 - 410 cd/m² | 0.8 - 410 cd/m² | — | USB Ports / Standard | USB:
Upstream port (x1), Downstream port (x2)
Ver.2.0 | USB:
Upstream port (x1), Downstream port (x2)
Ver.2.0 | – |
| Viewing Angle | CR>10:1
Viewing angle :
Horizontal: Typ.176 Vertical: Typ.176 | CR>10:1
Viewing angle :
Horizontal: Typ.178 Vertical: Typ.178 | The specification of the
proposed device is
superior to that of the
predicate device. | Scanning Frequency | DVI
74.1KHz, Vertical: 60Hz (Landscape)
98.1KHz, Vertical: 60Hz (Portrait)
DisplayPort
75.0KHz, Vertical: 60Hz (Landscape)
99.0KHz, Vertical: 60Hz (Portrait) | DVI
74.1KHz, Vertical: 60Hz (Landscape)
98.1KHz, Vertical: 60Hz (Portrait)
DisplayPort
75.0KHz, Vertical: 60Hz (Landscape)
99.0KHz, Vertical: 60Hz (Portrait) | – |
| Display Area | Horizontal: 324.0 mm, Vertical: 432.0 mm | Horizontal: 324.0 mm, Vertical: 432.0 mm | — | Maximum Image Clock | 162MHz | 162MHz | – |
| Rated | AC100-240V, 50/60Hz 1.5 – 0.6A | AC100-240V, 50/60Hz 2.2 – 1.1A | The difference does not
affect diagnosis. | | | | |
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7
| Luminance Calibration
(Optional) | Software: Medivisor Nx
Calibration Sensor (Optional): Chroma5 (X-Rite) | Software: F-CAL, Medivisor Agent
Calibration Sensor (Optional): i1Display (X-Rite) | Application software and
calibration sensor of the
proposed device currently
support those of the
predicate device. |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Sensor | Built-in Front Sensor | Built-in Front Sensor | Adding human presence
sensor does not affect
diagnosis, only for energy |
| | Built-in Ambient Light Sensor | Built-in Ambient Light Sensor | saving. |
| | None | Built-in Human presence sensor | |
| Safety Standards | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.
60601-1, FCC (Class B), ICES-003 (Class B),
MDD/CE, VCCI-B (Class B) | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.
60601-1, FCC (Class B), ICES-003 (Class B),
MDR/CE, RCM, VCCI-B (Class B) | Safety standards of the
predicate device currently
support those of the
proposed device.
(RCM is added) |
| Weight & Dimension | Net: Approximately 12.0kg
Landscape:
474.0 (w) x 468.4 - 529.9 (H) x 220.0 (D) mm
Portrait:
367.0 (w) x 521.9 - 583.4 (H) x 220.0 (D) mm
Packed: Approximately 15.0kg
470 (W) x 670 (H) x 340 (D) mm | Net: Approximately 9.3 kg (Filter Model)
Approximately 8.9 kg (Normal Model)
Landscape:
493.0 (w) x 451.3 – 546.3 (H) x 196.5 (D) mm
Portrait:
361.5 (w) x 517.0 - 612.0 (H) x 196.5 (D) mm
Packed: Approximately 12.3kg (Filter Model)
Approximately 11.9kg (Normal Model)
585 (W) x 580 (H) x 285 (D) mm | The difference does not
affect diagnosis. |