(86 days)
Not Found
No
The summary describes a medical monitor for displaying images, with no mention of AI/ML capabilities or image processing beyond display technology.
No.
The device is a monitor used for displaying medical images for diagnosis, not for providing therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device "is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners."
No
The device description explicitly states it is a 21.3-inch monochrome 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 for diagnosis. It is a display device for images generated by other medical equipment (digital mammography PACS and modalities).
- Lack of Biological Sample Interaction: The device does not interact with or analyze any biological samples from a patient. Its function is solely to present visual information.
Therefore, while it is a medical device used in the diagnostic process, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
21.3 inch Monochrome Digital Mammography 5M pixel LCD Monitor with sub-pixel driving techniques enabling 15M subpixels to be driven independently, MS55i2 (ML21055, MD211G5) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
MS55i2 (ML21055, MD211G5) is a 21.3-inch monochrome LCD monitor whose display 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 / digital mammography PACS and modalities including FFDM
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)
Not Found
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).
0
131137 2
JVCKENWOOD
JUL 1 8 2013
t
510(k) SUMMARY
| Submitted Information: | JVC KENWOOD Corporation
3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi,
Kanagawa, 221-0022 Japan |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tsukasa Tashiro, General Manager
Email: tashiro.tsukasa@jvckenwood.com
Tel: +81.258.24.6611
Fax: +81.258.24.6617 |
| Date Prepared: | July 17, 2013 |
| Device Name: | 21.3 inch Monochrome Digital Mammography LCD Monitor MS55i2
(ML21055, MD211G5) |
| Common Name: | MS55i2, ML21055, MD211G5 |
| Classification Name: | Class II
(Part 892 Radiology Devices
Sec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 21.3 inch (54 cm) Monochrome Digital Mammography LCD Monitor
MS53i2 (ML21053) (K111496). |
| Device Description: | MS55i2 (ML21055, MD211G5) is a 21.3-inch monochrome LCD
monitor whose display resolution is 2048 x 2560 (landscape), 2560 x
2048 (portrait) supporting DVI (digital visual interface)
and
DisplayPort. |
| Intended Use: | 21.3 inch Monochrome Digital Mammography 5M pixel LCD Monitor
with sub-pixel driving techniques enabling 15M subpixels to be driven
independently, MS55i2 (ML21055, MD211G5) is intended to be used in
displaying and viewing medical images for diagnosis by trained medical
practitioners. It is to be used in digital mammography PACS and
modalities including FFDM. |
| Substantial Equivalence: | MS55i2 (ML21055, MD211G5) shares the same characteristics with our
predicate device MS53i2 (ML21053) (K111496) except for the main
board, LCD panel and power supply. |
1
| - |
|---|
| 1 |
| And Status Load |
| 1 |
| 1 |
| 510(k) Number | 5M Monochrome Digital Mammography
LCD Monitor MS53i2 (ML21053) (K111496)
Conventional LCD Panel (IAQS80P) | 5M Monochrome Digital Mammography
LCD Monitor MS55i2 (ML21055, MD211G5)
New LCD Panel (TX54D84MM0BAA) |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display Area | K061447
Horizontal: 337.9mm, Vertical: 422.4mm | Not Known
Horizontal: 337.92mm, Vertical: 422.4mm |
| Input Signal | DVI, DisplayPort | DVI, DisplayPort |
| Maximum Display | 2048 x 2560 dots | 2048 x 2560 dots |
| Scanning Frequency | Horizontal: 129.6K, Vertical: 50Hz - Portrait
Horizontal: 103.93KHz, Vertical: 50Hz - Landscape | Horizontal: 129.6K, Vertical: 50Hz - Portrait
Horizontal: 103.5KHz, Vertical: 50Hz - Landscape |
| Maximum Image Clock | 148 MHz | 285 MHz |
| Maximum Luminance
(Calibrated Luminance) | Min.850 cd/m² Typ.1100cd/m²
(500 cd/m² - calibrated luminance) | Min.850 cd/m² Typ.1200cd/m² (as LCD component)
(500 cd/m² - calibrated luminance) |
| Contrast Ratio | Min.600 Typ.850 | Min.900 Typ. 1200 |
| Viewing Angle | CR>20 Typ.85deg | CR>50 Typ.176 horizontal/vertical |
| Luminance Calibration
(Optional) | Software (Standard): Medivisor
Calibration Sensor (Optional): Chroma5 (X-Rite) | Software (Standard): Medivisor
Calibration Sensor (Optional): Chroma5 (X-Rite) |
| Serial Communication | USB: Downstream port x 2, Upstream port x 1 | USB: Downstream port x 2, Upstream port x 1 |
| Grayscale | 10.3 bit (1276 gradation) | 10.3 bit (1276 gradation) |
| Safety Standard | UL60601-1, CSA C22.2 No. 601-1, FCC-B, VCCI-B, MDD/CE, | UL60601-1, CSA C22.2 No. 601-1, FCC-B, VCCI-B, MDD/CE, |
| Weight & Dimension | Net: 12.1kg
474.5(W) x 480(H) x 220(D) mm (Landscape)
389(w) x 522(H) x 220(D) mm (Portrait)
Packed: 17.0 Kg
470(W) x 685 (H) x 345(D) | Net: approx. 12.8kg
474.5(W) x 480(H) x 220(D) mm (Landscape)
390(w) x 522(H) x 220(D) mm (Portrait)
Packed: approx.16.0 Kg
470(W) x 685 (H) x 345(D) |
| Power Supply | AC100-240V, 1.5-0.6A, 50/60Hz | AC100-240V, 1.5-0.6A, 50/60Hz |
Similarities :
MS55i2 (ML21055) employs the same diver board, tilt stand, power supply, etc. except of those of LCD Panel (included inverter board
Differences: Differences:
ellinentees.
MS55i2 (ML21055) employs a different LCD backlight) and the Maximum Luminance, contrast ratio and viewing angle have been
improved. MD211G5 is the same as MS55
2
| Display System Description | ||
|---|---|---|
| 1. Active-Matrix Liquid-Crystal Displays (AMLCD) panel manufacturer, technology Screen size and | ||
| pixel pitch: | ||
| Screen size: 422.4mm(H) x 337.92mm(V) at landscape display. 337.92mm(H) x 422.4mm(V) at | ||
| portrait display. Pixel pitch: 0.055mm(H) (sub-pixel pitch) x 0.165mm(V) at landscape display. | ||
| 0.165mm(H) x 0.055mm(V) (sub-pixel pitch) at portrait display | ||
| • Communicating ports: | ||
| Serial communication: USB (upstream x1, downstream x2) | ||
| 2. Graphics card and software | ||
| • Digital-to-Analog converters: speed and precision: | ||
| Only Digital operation, Digital to Analog converters are not provided. | ||
| • Software included: calibration, QC/QA (procedures with required frequencies and action | ||
| limits): | ||
| Totoku's calibration software called "Mediviser" optimizes the display's performance using | ||
| DICOM GSDF gamma and luminance. Calibration is recommended quarterly. | ||
| • On-screen GUI: On-screen GUI is not provided. | ||
| • Panel user controls: power switch | ||
| Technical Specification | ||
| 1. Measuring Equipment | ||
| Refer to List | ||
| 3. Luminance response | 2. Declared and actual (measured with test pattern in the screen) array size: | |
| Declared array size (spec): 422.4mm(H) x 337.92mm(V) | ||
| Actual array size (measured): 422.35mm(H) x 337.95mm(V) | ||
| • max and min achievable luminance: | [SPEC] Luminance Max (L.max)=1200cd/m2. Luminance Min (Lmin)= 0.5cd/m2 | |
| • max and min recommended (operational) luminance: | [SPEC] Luminance Max recommend: Lmax(r)=500cd/m2. Lmin(r)=0.8cd/m2 | |
| • intrinsic bit-depth of the panel: [SPEC] 8bit per each subpixel | ||
| • true output bit-depth by performing visual test with gradient test pattern: | ||
| [SPEC] 10.3bit gray scale (1276 steps) achieved by 11bit LUT (Look-up Table) in the Display | ||
| hardware. | ||
| • intrinsic luminance response at 256 digital values: | ||
| [SPEC] dJND per dP 210(k) K131137 |
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