(29 days)
No reference devices were used in this submission.
No
The summary describes a medical display device and its technical specifications, focusing on image display quality and compliance with standards like DICOM. There is no mention of AI, ML, or any algorithms that perform analysis or interpretation of the images beyond basic display functions. The performance studies focus on display characteristics, not diagnostic performance based on image analysis.
No.
The device is a medical display system intended for displaying and viewing digital images for review and analysis; it does not directly treat or diagnose a medical condition.
No
This device is a medical display used for viewing and analyzing digital images. It does not perform diagnostic functions itself, but rather presents the images to a trained medical practitioner who then makes the diagnosis.
No
The device description explicitly lists hardware components such as a Liquid Crystal Display, Motherboard, Power Adapter, and Data Cable, in addition to the software.
Based on the provided information, the JUSHA-M53 Medical Display is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to display and view digital images for review and analysis by medical practitioners. This is related to medical imaging, not the examination of specimens derived from the human body.
- Device Description: The description focuses on the technical specifications of a display system (resolution, luminance, grayscale, compliance with DICOM, etc.). It does not mention any components or functions related to analyzing biological samples.
- Mentions image processing: While it mentions "image processing," this is in the context of displaying and manipulating medical images, not processing biological samples. The listed regulation (21 CFR 892.2050) is for "Picture archiving and communications system," which is related to medical imaging, not IVDs.
- Input Imaging Modality: The input is "digital images including those of digital mammography," which are medical images, not biological samples.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The JUSHA-M53 Medical Display's function is to present medical images for visual interpretation by a trained professional.
N/A
Intended Use / Indications for Use
JUSHA-M53 Medical Display is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.
Product codes
PGY
Device Description
JUSHA-M53 Medical Display is a display system with the high resolution (2560 x 2048), high luminance (1000 cd/m²), and 1024 simultaneous shades of gray out of a palette of 4096, 8 DICOM look up table with 12 bit inside. It is compliant with DICOM Part 14, and it has front sensor, presents induction system and ambient brightness adapting function. JUSHA-M53 employs energy efficient LED as backlight, it can achieve a high brightness and low power consumption at the same time. LED backlights deteriorate more slowly and thus the monitor offers a long service time.JUSHA-M53 with 10 bit (1024 tones) simultaneous grayscale display extends graysacle fidelity to the boundaries of human visual perception abilities and helps radiologists discern the finest nuances within an image.
The product is consisted of the following components:
- 21.3 inch, mono-TFT Liquid Crystal Display
- JUSHA-45T Motherboard/FR-4/REV1.0
- JUSHA-M53 Medical Display software
- Power Adapter
- Data Cable.
Mentions image processing
System, image processing (21 CFR 892.2050)
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital images including those of digital mammography
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)
Bench testing was conducted to demonstrate the JUSHA-M53 meets all performance standards as follows:
- . Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions
- . Measurement of the luminance non-uniformity characteristics of the display screen as specified in TGI18 guideline.
- . Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline.
- Measurement of small-spot contrast ratio.
- Measurement of temporal response
- Performance data on luminance stability
Electrical safety and EMC testing were conducted on the JUSHA-M53. The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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 U.S. Department of Health & Human Services. The logo consists of 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, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2015
Nanjing Jusha Display Technology Co., Ltd. % Mr. Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technology Services Co., Ltd. 7th Floor, Jingui Business Building No. 982 Congyun Road, Baiyun District Guangzhou, Guangdongg 510420 CHINA
Re: K150842
Trade/Device Name: JUSHA-M53 Medical Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: March 27, 2015 Received: March 30, 2015
Dear Mr. Gu:
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 A Ochs
Robert Ochs, Ph.D. Acting 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) K150842
Device Name JUSHA-M53 Medical Display
Indications for Use (Describe)
JUSHA-M53 Medical Display is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
l. SUBMITTER
Nanjing Jusha Display Technology Co., Ltd.
301, Hanzhongmen Street, 8F Block A, No.1, Nanjing International Service Outsourcing Mansion, Nanjing, 210036 China
Phone: (+86) 25- 83305050
Fax: (+86) 25- 58783271
| Primary Contact Person: | Mike Gu |
|---|---|
| ------------------------- | --------- |
Regulatory Affairs Manager
OSMUNDA Medical Device Consulting Co., Ltd
Tel: (+86) 20-6232 1333
Fax: (+86) 20-8633 0253
Jing Ma Secondary Contact Person:
Certification Engineer
Nanjing Jusha Display Technology Co., Ltd
Date Prepared: March 23, 2015
- II. DEVICE
- Name of Device: JUSHA-M53 Medical Display
ll
- Common/Usual Name: Display, 5M Grayscale Flat panel Display
- System, image processing (21 CFR 892.2050) Classification Names:
- Regulation Class:
- Product Code: LLZ
- III. PREDICATE DEVICE
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Eizo Nanao Corporation's RadiForce GX540, K130336
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
JUSHA-M53 Medical Display is a display system with the high resolution (2560 x 2048), high luminance (1000 cd/m²), and 1024 simultaneous shades of gray out of a palette of 4096, 8 DICOM look up table with 12 bit inside. It is compliant with DICOM Part 14, and it has front sensor, presents induction system and ambient brightness adapting function. JUSHA-M53 employs energy efficient LED as backlight, it can achieve a high brightness and low power consumption at the same time. LED backlights deteriorate more slowly and thus the monitor offers a long service time.JUSHA-M53 with 10 bit (1024 tones) simultaneous grayscale display extends graysacle fidelity to the boundaries of human visual perception abilities and helps radiologists discern the finest nuances within an image.
The product is consisted of the following components:
- 21.3 inch, mono-TFT Liquid Crystal Display
- -JUSHA-45T Motherboard/FR-4/REV1.0
- JUSHA-M53 Medical Display software
- Power Adapter
- Data Cable.
V. INDICATIONS FOR USE
JUSHA-M53 Medical Display is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
JUSHA-M53 Medical Display is the display system with the high resolution (2560 x 2048) monitor (5 megapixels) with electronic capabilities for evaluation of high resolution medical images. It uses a monochrome LCD panel with IPS (in-plane switching) technology, so that it can
6
achieve wide viewing angles. JUSHA-M53 has a backlight sensor inside to stabilize the set luminance level automatically. JUSHA-M53 also has an integrated front sensor used for independent grayscale. With high luminance (1000 cd/m²) and 1024 simultaneous shades of gray out of a palette of 4096, 8 DICOM look up table with 12 bit, DSA, DSI and CT/MRI-JS curve which are calibrated in our factory are stored -inside the display.JUSHA-M53 has a ambient brightness sensor used to adjust the luminance and DICOM LUT along with the ambient brightness changing when the ambient function is enable. It has a brightening quickly button which can adjust the luminance and curve when press the button, this can be used to switch the using mode between high luminance and low luminance level, the is luminance used for diagnosis, the low luminance level is used for normal reading.JUSHA-M53 has an infrared sensor to detect whether there is a person in front of the display, it is working when there is a person, and it will be in power saving mode if there is no person in front of it. The JUSHA-M53 employs the same technology as its predicate devices K130336.
| Items | Predicate Device | Proposed Device |
|---|---|---|
| Product | RADIFORCE GX540 | JUSHA-M53 Medical Display |
| 510(k) Number | K130336 | / |
| Display Performance/Specifications | ||
| Screen technology | 21.3"TFT Monochrome | |
| LCD Panel | 21.3"TFT Monochrome LCD Panel | |
| Viewing angle (H,V) | Horizontal | |
| 176°, Vertical 176° | Horizontal 176°, Vertical 176° | |
| Resolution | $2048\times2560$ | $2048\times2560$ |
| Display area | $337.9\times 422.4$ mm | $337.9 \times 422.4$ mm |
| Aspect ratio | 4:5 | 4:5 |
| Contrast Ratio(typ) | 1200:1 | 1200:1 |
| Recommended brightness | 500cd/m² | 500cd/m² |
| Pixel Pitch | $0.165\times0.165$ mm | $0.165\times0.165$ mm |
| Backlighting | LED backlight | LED backlight |
| grayscale | 1024 | 1024 |
| Response time | 25ms | 25ms |
| Sensor | Backlight sensor, | |
| Integrated front sensor, | ||
| Presence sensor, | ||
| Ambient light sensor | Backlight sensor, Integrated front | |
| sensor, Presence sensor, Ambient | ||
| light sensor | ||
| Video Signal Input | ||
| Input signals | DVI standard 1.0 | DVI standard 1.0 |
| Input terminational | 1 DVI-D Dual Link | |
| 1 Display Port | 1 DVI-D Dual Link | |
| 1 Display port | ||
| Display controller | Off the shelf | Off the shelf |
| Scanning Frequency (H,V) | 31 - 135 kHz /24 -61 Hz | |
| Frame synchronous | ||
| mode: 24.5 - 25.5 Hz, 49 | ||
| -51 Hz | 123KHz/60Hz | |
| Power Related Specification | ||
| Power Requirement | 100 - 120 Vac ±10%, | |
| 50/60 Hz 1.1 - 0.9A |
200 - 240 Vac ±10%,
50/60 Hz 0.6 - 0.5A | 100 - 120 Vac ±10%, 50/60 Hz 1.1 -
0.9A
200 - 240 Vac ±10%, 50/60 Hz 0.6 -
0.5A |
| Power Consumptions/Save
Mode | 108W/less than 0.7W | 48.9W/less than 1.5W |
| Power Management | DVI DMPM | DVI DMPM |
| Miscellaneous Features/Specifications | | |
| USB Ports/standard | 1 upstream (endpoint),
2 downstream | 1 upstream (endpoint), 2
downstream |
| Dimensions w/o stand
(W x H x D) | With stand: | With stand: |
| | 338×512-595×245.5 | 395×238×530 |
| | Without stand: | Without stand: |
| | 688.5×496×99 mm | 395×74×491 |
| Indication for use | RadiForce GX540 is
intended to be used in
displaying and viewing
digital images, including
those of digital
mammography, for
review and analysis by
trained medical
practitioners. | JUSHA-M53 Medical Display is
intended to be used in displaying
and viewing digital images, including
those of digital mammography, for
review and analysis by trained
medical practitioners. |
| Applicable standard | 1 IEC 60601-1Medical
equipment medical
electrical equipment -
Part 1: General
requirements for basic
safety and essential
performance 1988+A1 :
1991 + A2:1995
2 IEC 60601-1-2 Edition
3:2007, Medical
electrical equipment -
Part 1-2: General
requirements for basic
safety and essential
performance -
Collateral standard:
Electromagnetic
compatibility -
Requirements and
tests. | 1 IEC 60601-1Medical equipment
medical electrical equipment - Part
1: General requirements for basic
safety and essential performance
1988+A1 : 1991 + A2:1995
2 IEC 60601-1-2 Edition 3:2007,
Medical electrical equipment - Part
1-2: General requirements for basic
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and
tests. |
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8
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Bench testing:
Bench testing was conducted to demonstrate the JUSHA-M53 meets all performance standards as follows:
- . Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions
- . Measurement of the luminance non-uniformity characteristics of the display screen as specified in TGI18 guideline.
- . Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline.
- Measurement of small-spot contrast ratio.
- Measurement of temporal response
- Performance data on luminance stability
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the JUSHA-M53. The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
Animal and clinical study
The subject of this premarket submission, JUSHA-M53, does not require animal or clinical studies to support substantial equivalence.
VIII. CONCLUSIONS
JUSHA-M53 Medical Display is substantially equivalent to the predicate device with respect to technical characteristics, performance, application and intended use. The non-clinical data support the safety of the device should perform as intended in the specified use conditions. Nanjing Jusha Display Technology Co., Ltd considers the JUSHA-M53 Medical Display does not raise any new issues of safety or effectiveness.