(56 days)
Not Found
No
The description focuses on the display's technical specifications (resolution, luminance, grayscale, DICOM LUTs) and compliance with safety and EMC standards. There is no mention of AI/ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a monitor intended for displaying digital images for review and analysis by medical practitioners, not for direct therapeutic intervention. Its function is descriptive and diagnostic support, not therapeutic.
Yes
The device is intended to be used in "displaying digital images for review and analysis by trained medical practitioners," which directly supports diagnostic activities even if it doesn't perform the diagnosis itself. The phrase "does not support the display of mammography images for diagnosis" implies that it supports other types of images for diagnosis.
No
The device description explicitly lists hardware components (LCD, FR4-v0.4, Power Adapter, Data Cable) in addition to the software.
Based on the provided information, the JUSHA-C43 LCD Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "displaying digital images for review and analysis by trained medical practitioners." This is a display device for medical images, not a device that performs tests on biological samples or provides diagnostic information based on such tests.
- Device Description: The description focuses on the technical specifications of the display (resolution, luminance, grayscale, DICOM support) and its components. It doesn't mention any components or functionalities related to analyzing biological samples or performing in vitro tests.
- Standards: The listed standards (IEC 60601-1 and IEC 60601-1-2) are general standards for medical electrical equipment, focusing on safety and electromagnetic compatibility. They are not specific to IVD devices.
- Performance Studies: The performance studies described are related to the display's characteristics (luminance, uniformity, contrast, temporal response) and electrical safety/EMC. There are no studies related to the accuracy or performance of in vitro tests.
- Lack of IVD-specific information: The document lacks any mention of reagents, assays, sample handling, or any other elements typically associated with IVD devices.
In summary, the JUSHA-C43 LCD Monitor is a medical device used for displaying medical images, which is a different category than In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
JUSHA-C43 LCD Monitor is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Product codes
PGY
Device Description
JUSHA-C43 LCD Monitoris the display system with the high resolution(2560 x 1600), high luminance(350cd/m²) and 1024 simultaneous shades of gray out of a palette of 4096, 4 DICOM look up table inside, the product is consisted of the following components:
- 30inch, Color Active Matrix Liquid Crystal Display
- FR4-v0.4
- JUSHA-C43 LCD Monitor software
- Power Adapter
- Data Cable.
The LCD Monitoris designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards:
- IEC 60601-1Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2005 + CORR. 1 (2006) +CORR. 2 (2007)
- 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.
Mentions image processing
Yes
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
Bench testing was conducted to demonstrate the JUSHA-C43 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) testing were conducted on the JUSHA-C43. The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
The subject of this premarket submission, JUSHA-C43, does not require animal or clinical studies to support substantial equivalence.
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).
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 10, 2015
Nanjing Jusha Display Technology Co., Ltd. % Ma Jing Certification Engineer 301 Hnazhongmen Street, 8F Block A, No. 1 Nanjing International Service Outsourcing Mansion, Nanjing Jiangsu 210036 CHINA
Re: K151972
Trade/Device Name: JUSHA-C43 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: June 16, 2015 Received: July 16, 2015
Dear Ma Jing:
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 Ochs
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
Indications for Use
510(k) Number (if known) K151972
Device Name JUSHA-C43 LCD Monitor
Indications for Use (Describe)
JUSHA-C43 LCD Monitor is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
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
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | Jun,15,2015 |
|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd |
| Add: 301, Hanzhongmen Street, 8F Block A, No.1, Nanjing | |
| International Service Outsourcing Mansion, Nanjing, 210036 China | |
| Contact Person: | Ma Jing |
| Certification Engineer | |
| Nanjing Jusha Display Technology Co., Ltd | |
| Tel: +86-25- 83305050 | |
| Fax: +86-25- 58783271 | |
| Device Trade Name: | JUSHA-C43 LCD Monitor |
| Common/Usual Name: | 4MP Color LCD Monitor |
| Classification Name: | System, image processing ,Radiology |
| Product Code: | PGY |
| Predicate Device(s): | RADIFORCE RX440;K130070 |
| Device Description: | JUSHA-C43 LCD Monitoris the display system with the high |
| resolution(2560 x 1600), high luminance(350cd/m²) and 1024 | |
| simultaneous shades of gray out of a palette of 4096, 4 DICOM | |
| look up table inside, the product is consisted of the following | |
| components: |
- 30inch, Color Active Matrix Liquid Crystal Display
- FR4-v0.4 |
| - JUSHA-C43 LCD Monitor software - Power Adapter
- Data Cable.
The LCD Monitoris designed, tested, and will be manufactured
in accordance with both mandatory and voluntary standards:
- IEC 60601-1Medical equipment medical electrical
equipment - Part 1: General requirements for basic
safety and essential performance 2005 + CORR. 1
(2006) +CORR. 2 (2007) - 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. | |
| Intended Use: | JUSHA-C43 LCD Monitoris intended to be used in displaying
and viewing digital images for review and analysis by trained
medical practitioners. It does not support the display of
mammography images for diagnosis. |
| Technology: | JUSHA-C43 LCD Monitor is the display system with the high
resolution monitor (4 megapixels) with electronic capabilities for
evaluation of high resolution medical images, high
luminance(350cd/m²) and 1024 simultaneous shades of gray
out of a palette of 4096, 4 DICOM look up table inside |
| Determination of
Substantial Equivalence: | Summary of Non-Clinical Tests:
The LCD Monitor complies with voluntary standards as
following:
1 IEC 60601-1Medical equipment medical electrical |
4
5
6
| | require clinical studies to support substantial equivalence.
The proposed device is Substantially Equivalent (SE) to the
predicate device which is US legally market device. Therefore,
the subject device is determined as safe and effectiveness. |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | Nanjing Jusha Display Technology Co., Ltd Considers the
JUSHA-C43 LCD Monitor to be as safe as effective, and
performance is substantially equivalent to the predicate
device(s). |
7
This comparison identifies the similarities and differences of the proposed JUSHA-C43 LCD Monitor device to the legally marketed predicate EIZO RADIFORCE RX440 LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|------------------------------------|----------------------------------|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Product | RADIFORCE RX440 | JUSHA-C43 LCD Monitor | |
| 510(k) Number | K130070 | / | |
| Display Performance/Specifications | | | |
| Screen
technology | 29.8" Color TFT LCD
Panel | 30", Color Active Matrix
TFT LCD Panel | The panel of
JUSHA-C43 is larger
than the predicate
device, it can display
more
information |
| Viewing angle
(H, V) | Horizontal 176°,Vertical
176° | Horizontal 178°,Vertical
178°(CR > 10) | The viewing angle of
JUSHA-C43 is wider
than the predicate
device, it can get
greater field of view |
| Resolution | 2560 x1600/1280 x1600
x2 | 2560 x 1600/1280 x 1600
x2 | Same |
| Display area | 641.2(H) x 400.8 (V) mm | 641.28 (H) x 400.8 (V) mm | Same |
| Recommended
Luminance | 300cd/m² | 300cd/m² | Same |
8
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | RADIFORCE RX440 | JUSHA-C43 LCD Monitor | |
| 510(k) Number | K130070 | / | |
| Contrast Ratio | 1100:1 | 1200:1 | The contrast ratio of
JUSHA-C43 is higher
than the predicate
device, it can display
image more clarity |
| Scanning
frequency (H; V) | 31 - 159 kHz / 29 - 61 Hz
(VGA Text: 69 - 71 Hz)
Frame synchronous
mode: 59 - 61 Hz, 29.5 -
30.5 Hz | 103.8kHz;50Hz | The two differences
between the two
device is caused by
the different no
display area defined
by different
manufacturers, but
the display area is
same(20482560),so
the same picture
displayed on the two
devices has the same
effect |
| Dot clock | 152MHz | 148MHz | by different
manufacturers, but
the display area is
same(20482560),so
the same picture
displayed on the two
devices has the same
effect |
| Pixel Pitch | 0.2505 x 0.2505 mm | 0.2505 x 0.2505 mm | Same |
| Backlighting | LED | LED | Same |
9
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|-----------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Product | RADIFORCE RX440 | JUSHA-C43 LCD Monitor | |
| 510(k) Number | K130070 | / | |
| Display Colors | 10-bit, 1.07 billion colors | 12-bit , 68.7billion colors | The JUSHA-C43 LCD
Monitor uses a color
extension technology
to improve image
display quality |
| Luminance
calibration | Built in calibration sensor
provided | Built in calibration sensor
provided | Same |
| Video Signal Input | | | |
| Input signals | DVI standard 1.0 | DVI standard 1.0 | Same |
| Input
terminational | DVI-D (dual link) x 1,
DVI-D (single link) x 1,
DisplayPort x 1 | DVI-D (dual link) x 1,
DVI-D (single link) x 1,
DisplayPort x 1 | Same |
| Display
controller | Off the shelf | Off the shelf | Same |
| Power Related Specification | | | |
| Power
Requirement | AC 100 - 120 V, 200 - 240
V: 50 / 60 Hz | AC 100-240V 50-60Hz | same |
10
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|----------------------------------------|----------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | RADIFORCE RX440 | JUSHA-C43 LCD Monitor | |
| 510(k) Number | K130070 | / | |
| Power
Consumptions/Save Mode | 84W/less than 0.7W | 82W/less than1.5W | The differences
caused by different
adapter and
components used in
the LCD Monitor, the
JUSHA-C43 has
fewer power
consumptions, this
only shows the power
consumption is
different, nothing to
do with the display
function |
| Power
Management | DVI DMPM, DisplayPort
1.1a | DVI DMPM, DisplayPort
1.1a | Same |
| Miscellaneous Features/Specifications | | | |
| USB
Ports/standard | 1 upstream ,
2 downstream/ Rev. 2.0 | 1 upstream (endpoint), 2
downstream/ Rev. 2.0 | Same |
| Dimensions w/o
stand
(W x H x D) | Without stand:
702x108x473 mm | With stand:
692x252x523mm
Without stand:
692x87x453mm | Different housing
design due to the
different panel size. |
11
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Product | RADIFORCE RX440 | JUSHA-C43 LCD Monitor | |
| 510(k) Number | K130070 | / | |
| Indication for use | RADIFORCE RX440 is
intended to be used in
displaying and viewing
digital images for review
and analysis by trained
medical practitioners. It
does not support the
display of mammography
images for diagnosis. | JUSHA-C43 LCD Monitor
is intended to be used in
displaying and viewing
digital images for review
and analysis by trained
medical practitioners. It
does not support the
display of mammography
images for diagnosis. | Same |
12
| Attributes | Predicate Device | Proposed Device | Discussion of Differences |
|---|---|---|---|
| Product | RADIFORCE RX440 | JUSHA-C43 LCD Monitor | |
| 510(k) Number | K130070 | / | |
| 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 | |||
| IEC 60601-1:2005 + | |||
| CORR. 1 (2006) +CORR. 2 (2007) | |||
| 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. | The JUSHA-C43 | ||
| safety standard is | |||
| edition 3.0, | |||
| RADIFORCE RX440 | |||
| safety standard is | |||
| edition 2.0. nothing to | |||
| do with the display | |||
| function |
13
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-C43 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-C43. 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-C43, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
JUSHA-C43 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-C43 Medical Display does not raise any new issues of safety or effectiveness.