(112 days)
Not Found
No
The device description focuses on display technology and calibration features, with no mention of AI or ML algorithms for image analysis or interpretation.
No
The device is an LCD monitor intended for displaying and viewing digital medical images for diagnosis, not for providing therapy.
Yes.
The "Intended Use / Indications for Use" section states that the device "is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners." This explicitly indicates a diagnostic purpose.
No
The device description explicitly lists hardware components such as an LCD Panel, main board, power adapter, and data cable, in addition to software. The performance studies also focus on the physical characteristics and electrical safety of the hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "displaying and viewing digital images for diagnosis of X-ray or MRI, etc." This describes a device used to visualize medical images, not a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis.
- Device Description: The description focuses on the technical specifications of a monitor designed for displaying medical images (resolution, luminance, color, DICOM support, etc.). It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD-related information: There is no mention of reagents, assays, sample handling, or any other elements typically associated with IVD devices.
IVD devices are specifically designed to perform tests on biological samples to aid in diagnosis. This device is a display monitor used to present images generated by other diagnostic modalities (like X-ray and MRI).
N/A
Intended Use / Indications for Use
JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
JUSHA-C350G LCD Monitor , JUSHA-C350 LCD Monitor , C350G LCD Monitor , C350 LCD Monitor is the display system with the high resolution monitor (3 megapixels) with electronic capabilities for evaluation of high resolution medical images, high luminance (800 cd/m²) and 281.47 trillion colors, built-in DICOM standard LUT. JUSHA-C350G LCD Monitor contains CGA function, it is specially made by JUSHA, it can automatic identify gray and color signals, then gray area calls DICOM LUT and color area calls GAMMA2.2 LUT. In addition, JUSHA-C350G has ambient brightness adapting, 3D LUT color calibration, real-time DICOM automatic calibration, Full-screen brightness equalization, presence induction and focusview function, with these this display can automatic adjustment accordingThe product is consisted of the following components: - 21.3" Color TFT LCD Panel - DMX0704AR0/main board/REV1.1 - JUSHA-C350G LCD Monitor software - Power Adapter - Data Cable. The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards: 1. IEC 60601-1:2012, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance. 2. IEC 60601-1-2 Edition 4:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray or MRI
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-C350G 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-C350G. 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-C350G, does not require animal or clinical studies to support substantial equivalence.
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.
JUSHA-C33C; K141684
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Nanjing Jusha Display Technology Co., Ltd. % Zilong Liang Certification Manager Suite A. 8/F, Bldg 1, No. 301, Hanzhongmen St. Nanjing, Jiangsu 210036 CHINA
April 8, 2019
Re: K183496
Trade/Device Name: JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: January 11, 2019 Received: January 11, 2019
Dear Zilong Liang:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, subject to the general controls provisions of the Act. Although this letter refers to your products as devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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3
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | December 1, 2018 |
|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd |
| Add: 301, 8F Block A, No.1, Nanjing International Service | |
| Outsourcing Mansion, Hanzhongmen Street,Nanjing, 210036 China | |
| Contact Person: | Zilong Liang |
| Certification Manager | |
| Nanjing Jusha Display Technology Co., Ltd | |
| Tel: +86-25- 83305050 | |
| Fax: +86-25- 58783271 | |
| Device Trade Name: | JUSHA-C350G LCD Monitor , JUSHA-C350 LCD Monitor , |
| C350G LCD Monitor , C350 LCD Monitor | |
| Common/Usual Name: | 3MP Color LCD Monitor |
| Classification Name: | Display, Diagnostic Radiology 21CFR 892.2050 |
| Product Code: | PGY |
| Predicate Device(s): | JUSHA-C33C; K141684 |
| Device Description: | JUSHA-C350G LCD Monitor , JUSHA-C350 LCD Monitor , |
| C350G LCD Monitor , C350 LCD Monitor is the display system with | |
| the high resolution monitor (3 megapixels) with electronic capabilities | |
| for evaluation of high resolution medical images, high luminance (800 | |
| cd/m²) and 281.47 trillion colors, built-in DICOM standard LUT. | |
| JUSHA-C350G LCD Monitor contains CGA function, it is specially | |
| made by JUSHA, it can automatic identify gray and color signals, | |
| then gray area calls DICOM LUT and color area calls GAMMA2.2 | |
| LUT. In addition, JUSHA-C350G has ambient brightness adapting, | |
| 3D LUT color calibration, real-time DICOM automatic calibration, | |
| Full-screen brightness equalization, presence induction and focusview | |
| function, with these this display can automatic adjustment accordingThe product is consisted of the following components: |
- 21.3" Color TFT LCD Panel
- DMX0704AR0/main board/REV1.1
- JUSHA-C350G LCD Monitor software
- Power Adapter
- Data Cable.
The LCD Monitor is designed, tested, and will be manufactured in
accordance with both mandatory and voluntary standards:
- IEC 60601-1:2012, Medical equipment medical electrical
equipment - Part 1: General requirements for basic safety |
| | and essential performance. |
| | 2. IEC 60601-1-2 Edition 4:2014, Medical electrical
equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral standard:
Electromagnetic disturbances - Requirements and tests. |
| Intended Use: | JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor,
C350G LCD Monitor, C350 LCD Monitor is intended to be used in
displaying and viewing digital images for diagnosis of X-ray or MRI,
etc. by trained medical practitioners. The device does not support the
display of mammography images for diagnosis. |
| Technology: | JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor,
C350G LCD Monitor, C350 LCD Monitor is the display system with
the high resolution monitor (3 megapixels) with electronic capabilities
for evaluation of high resolution medical images, high luminance (800
cd/m²) and 281.47 trillion colors, built-in DICOM standard LUT.
JUSHA-C350G LCD Monitor contains CGA function, it is specially
made by JUSHA, it can automatic identify gray and color signals,
then gray area calls DICOM LUT and color area calls GAMMA2.2
LUT. In addition, JUSHA-C350G has ambient brightness adapting,
3D LUT color calibration, real-time DICOM automatic calibration,
Full-screen brightness equalization, presence induction and focusview
function, with these this display can automatic adjustment according
to different requirements in order to achieve the best results. |
| Determination of Substantial
Equivalence: | Summary of Non-Clinical Tests:
The LCD Monitor complies with voluntary standards as following:
1 IEC 60601-1:2012, Medical equipment medical electrical
equipment - Part 1: General requirements for basic safety and
essential performance.
2 IEC 60601-1-2 Edition 4:2014, Medical electrical equipment -
Part 1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic disturbances -
Requirements and tests.
JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor,
C350G LCD Monitor, C350 LCD Monitor is substantially equivalent
to JUSHA-C33C. JUSHA-C350G employs the maximum resolution
values same as that of JUSHA-C33C. Comparison table of the
principal characteristics of 2 devices is shown in the Attachment 1.
Attachment 1
The following quality assurance measures were applied to the
development of the system:
• Risk Analysis
• Requirements Reviews
• Design Reviews |
| | Testing on unit level (Module verification) Integration testing (System verification) Final acceptance testing (Validation) Performance testing (Verification) Safety testing (Verification) Summary of Clinical Tests:
The subject of this premarket submission, LCD Monitor, did not
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-C350G LCD Monitor, JUSHA-C350 LCD Monitor,
C350G LCD Monitor, C350 LCD Monitor to be as safe, as effective,
and performance is substantially equivalent to the predicate device(s). |
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5
12.1 Product Comparison
This comparison identifies the similarities and differences of the proposed JUSHA-C350G LCD Monitor device to the legally marketed predicate JUSHA-C33C LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|------------------------------------|------------------|----------------------------|------------------------------|
| Product | JUSHA-C33C | JUSHA-C350G LCD
Monitor | |
| 510(k) Number | K141684 | / | |
| Display Performance/Specifications | | | |
6
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | JUSHA-C33C | JUSHA-C350G LCD
Monitor | |
| 510(k) Number | K141684 | / | |
| Screen
technology | 21.3" Color TFT LCD Panel | 21.3" Color TFT LCD Panel | Same |
| Viewing angle
(H, V) | Horizontal 176°,Vertical
176° | Horizontal 178°,Vertical
178° | - |
| Resolution | 2048 x 1536/1536x 2048 | 2048 x1536/1536x 2048 | Same |
| Display area | 324.864(H) x 433.152
(V)
mm | 323.942(H) x 431.923
(V)
mm | - |
| Contrast Ratio | 1400:1 | 1400:1 | same |
| Scanning
frequency (H; V) | 96.7kHz;60Hz | 37.995.4kHz;60Hz | This difference240V 50~60Hz | DC 24V | - |
between the two
device is caused
by the different
no display area
defined by
different
manufacturers ,
nothing to do
with the display
function |
| Recommended
Luminance | 400cd/m2 | 450cd/m² | - |
| Pixel Pitch | 0.2115 x 0.2115 mm | 0.2109x0.2109 mm | - |
| Backlight | LED | LED | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | JUSHA-C33C | JUSHA-C350G LCD
Monitor | - |
| 510(k) Number | K141684 | / | - |
| Display Colors | 12-bit, 68.7 billion colors | 16-bit, 281.47 Trillion
colors | The
JUSHA-C350G
LCD Monitor
uses a color bit
expansion
technology to
improve image
display quality,
the image clarity
is better than the
image displayed
on the predicate
device. |
| Luminance
calibration | Built in calibration sensor
provided | Built in calibration sensor
provided | Same |
| Video Signal Input | | | |
| Input signals | DVI-D (dual link) x 1,
DisplayPort x 1 | DVI-D (dual link) x 1,
DisplayPort x 1 | - |
| Output Signal | - | DisplayPort x1 | - |
| Display
controller | Off the shelf | Off the shelf | Same |
| Power Related Specification | | | |
| Power
Requirement | AC 100
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | JUSHA-C33C | JUSHA-C350G LCD
Monitor | |
| 510(k) Number | K141684 | / | |
| Power
Consumption/Sa
ve Mode | 65W/less than 3W | 80W/less than 0.5W | The differences
caused by
different adapter
and components
used in the LCD
Monitor, the
JUSHA-C350G
has more power
consumption and
lower save mode
power
consumption.
This only shows
the power
consumption is
different,
nothing to do
with the display
function |
| Power | DVI DMPM | DVI DMPM | - |
| Management | DisplayPort 1.1a | DisplayPort 1.2a | |
| Miscellaneous Features/Specifications | | | |
| USB
Ports/standard | 1 upstream (endpoint),
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:
376mmx505mmx98 mm | Without stand:
356mm x476mm x85mm
With stand: | Different
housing design
due to the
different panel |
| | With stand:
376mmx599mmx245.5mm | 356mm x525mm x238mm | size. |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | JUSHA-C33C | JUSHA-C350G LCD Monitor | |
| 510(k) Number | K141684 | / | |
| Indication for use | JUSHA-C33C LCD Monitor
is intended to be used in
displaying and viewing
digital images for diagnosis
of X-ray or MRI, etc. by
trained medical practitioners.
The device does not support
the display of mammography
images for diagnosis. | JUSHA-C350G LCD
Monitor is intended to be
used in displaying and
viewing digital images for
diagnosis of X-ray or MRI,
etc. by trained medical
practitioners. The device
does not support the display
of mammography images for
diagnosis. | Same |
| Applicable
standard | 1 IEC 60601-1Medical
equipment medical electrical
equipment - Part 1: General
requirements for basic safety
and essential performance
2005+CORR.1(2006)+COR
R.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. | 1 IEC 60601-1:2012,
Medical equipment medical
electrical equipment - Part 1:
General requirements for
basic safety and essential
performance.
2 IEC 60601-1-2 Edition
4:2014, Medical electrical
equipment - Part 1-2:
General requirements for
basic safety and essential
performance - Collateral
standard: Electromagnetic
disturbances - Requirements
and tests. | - |
7
8
9
10
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-C350G 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-C350G 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-C350G, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
JUSHA-C350G/JUSHA-C350/C350G/C350 LCD Monitor 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-C350G Medical Display does not raise any new issues of safety or effectiveness.