(54 days)
Not Found
No
The description focuses on the display's technical specifications and compliance with standards, with no mention of AI/ML capabilities. The "automatic adjustment" feature is likely a standard display calibration function, not indicative of AI/ML.
No
The device is a display monitor for digital images and does not provide any therapeutic function. Its intended use is for review and analysis by medical practitioners.
Yes
This device is a diagnostic device because its intended use is "displaying digital images for review and analysis by trained medical practitioners," which directly supports medical diagnosis.
No
The device description explicitly lists hardware components like a "13.5" Color-TFT LCD Panel" and mentions testing against hardware standards like IEC 60601-1 and IEC 60601-1-2. While it includes software, it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "displaying digital images for review and analysis by trained medical practitioners." This describes a device used for viewing medical images, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description focuses on the technical specifications of a display monitor (resolution, luminance, color, DICOM standard LUT). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Measurement of biomarkers or analytes
- Diagnostic testing procedures
The device is clearly a medical image display monitor, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
CP620G/CP620 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.
CP620G/CP620 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.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
CP620G/CP620 LCD Monitor is the display system with the high resolution (3000*2000), high luminance (500 cd/m2), and 4398 billion Monitor is portable and light, the 750g weight make it is easy to carry. With these this display can automatic adjustment according to different requirements in order to achieve the best results.(There is no difference between CP620G and CP620 except for labeling as they are marketed in different areas. CP620G is global sales, CP620 is domestic sales .It does not affect their safety or effectiveness in any terms. )
The product is consisted of the following components:
- 13.5" Color-TFT LCD Panel
- DMS3400AR0/6 layers/214*150mm/1.0mm/REV:1.0
- CP620G LCD Monitor software
- Power Adapter
- Data Cable.
In accordance with the May 11, 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software level of concern for the CP620G/CP620 LCD Monitor was determined to be Moderate on account of a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. the software doesn't include any functions of image manipulation.
The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards:
- IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010,CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted to demonstrate the CP620/CP620G 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 .
- Measurement of the chromaticity non-uniformity characteristics of the display screen.
- 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 CP620G 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, CP620G, 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-CP610; K200742
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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Nanjing Jusha Display Technology Co., Ltd. % Donny Lee Certification Engineer 8A, Block 1. No. 301, Hanzhongmen Street Nanjing, Jiangsu 210036 CHINA
May 1, 2023
Re: K230643
Trade/Device Name: CP620G LCD monitor, CP620 LCD monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: March 9, 2023 Received: March 9, 2023
Dear Donny Lee:
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 medical devices and radiation-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.
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230643
Device Name CP620G LCD Monitor / CP620 LCD Monitor
Indications for Use (Describe)
CP620G/CP620 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)
| Research Use (Part 1, CFR 301 Subpart D) |
|---|
| Commodity Use (Part 1, CFR 319) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
(K230643)
1.In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | Mar 3, 2023 |
|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd |
| Add: 8A, Block 1. Nanjing International Service Outsourcing Mansion, | |
| No. 301, Hanzhongmen street, Nanjing City, Jiangsu Province, 210036 | |
| China. | |
| Contact Person: | Donny Lee |
| Certification Engineer | |
| Nanjing Jusha Display Technology Co., Ltd | |
| Tel: +86-25- 83305050 | |
| Fax: +86-25- 58783273 | |
| Device Trade | |
| Name: | CP620G LCD Monitor, CP620 LCD Monitor |
| Common/Usual | |
| Name: | 6MP Color LCD Monitor |
| Classification | |
| Name: | Medical Image Management and Processing System, 21 CFR 892.2050 |
| Product Code: | PGY |
| Device Class | Class II |
| Predicate | |
| Device(s): | JUSHA-CP610; K200742 |
| Classification | |
| Name: | Medical Image Management and Processing System ,21 CFR 892.2050 |
| Product Code: | PGY |
| Device Class | Class II |
| Device | |
| Description: | CP620G/CP620 LCD Monitor is the display system with the high |
| resolution (3000*2000), high luminance (500 cd/m2), and 4398 billion | |
| Monitor is portable and light, the 750g weight make it is easy to carry. | |
| With these this display can automatic adjustment according to different | |
| requirements in order to achieve the best results.(There is no difference | |
| between CP620G and CP620 except for labeling as they are marketed | |
| in different areas. CP620G is global sales, CP620 is domestic sales .It | |
| does not affect their safety or effectiveness in any terms. ) | |
| The product is consisted of the following components: |
- 13.5" Color-TFT LCD Panel
- DMS3400AR0/6 layers/214*150mm/1.0mm/REV:1.0
- CP620G LCD Monitor software
- Power Adapter
- Data Cable.
In accordance with the May 11, 2005 Guidance for the Content of
Premarket Submissions for Software Contained in Medical Devices, the
software level of concern for the CP620G/CP620 LCD Monitor was
determined to be Moderate on account of a failure or latent flaw could
indirectly result in minor injury to the patient or operator through incorrect
or delayed information or through the action of a care provider. the
software doesn't include any functions of image manipulation.
The LCD Monitor is designed, tested, and will be manufactured in
accordance with both mandatory and voluntary standards:
- IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI
ES60601-1:2005+A1:2012+C1:2009+A2:2010,CAN/CSA
C22.2 NO.60601-1:14, Medical equipment medical electrical
equipment - Part 1: General requirements for basic safety and
essential performance. - IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, Medical
electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral standard:
Electromagnetic disturbances - Requirements and tests. |
| Intended Use: | CP620G/CP620 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. |
| Technology: | CP620G/CP620 LCD Monitor is the display system with the high
resolution (3000*2000), high luminance (500 cd/m²), and 4.398 billion |
| colors, built-in DICOM standard LUT. In particular, CP620G/CP620 LCD
Monitor is portable and light, the 750 g weight make it is easy to carry.
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, EN 60601-1:2013, ANSI/AAMI
ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2
NO.60601-1:14, Medical equipment medical electrical equipment -
Part 1: General requirements for basic safety and essential
performance.
2 IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, Medical
electrical equipment - Part 1-2: General requirements for basic safety
and essential performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests
CP620G LCD Monitor are substantially equivalent to JUSHA-CP610
LCD Monitor. They have equivalent characteristics and functions
according to comparison table, please refer to 2. Product Comparison
The following quality assurance measures were applied to the
development of the system:
• Risk Analysis
• Requirements Reviews
• Design Reviews
• Raw materials verification
• 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
CP620G/CP620 LCD Monitor to be as safe as effective and performance |
| | is substantially equivalent to the predicate device(s). |
4
5
6
2. Product Comparison
This comparison identifies the similarities and differences of the proposed CP620G LCD Monitor device to the legally marketed predicate JUSHA-CP610 LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|------------------------------------|----------------------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Product | JUSHA-CP610 | CP620G LCD Monitor | |
| 510(k) Number | K200472 | K230643 | |
| Display Performance/Specifications | | | |
| Screen
technology | 13.5" Color TFT LCD Panel | 13.5" Color TFT LCD Panel | Same |
| Viewing
angle
(H, V) | Horizontal 170°,Vertical
170° | Horizontal 170°,Vertical
170° | Same |
| Resolution | 3000×2000 | 3000×2000 | Same |
| Display area | 285.3(V)×190.2(H)mm | 285.3(V)×190.2(H)mm | Same |
| Contrast Ratio | 1800:1 | 1800:1 | Same |
| Scanning
frequency (H; V) | 94.94123.84kHz; 60Hz | 94.94123.84kHz; 60Hz | Same |
| Recommended
Luminance | 300cd/m2 | 500cd/m2 | CP620G is better
than CP610 |
| Pixel Pitch | 0.0951×0.0951mm | 0.0951×0.0951mm | Same. |
| Backlight | LED | LED | Same. |
| Display Colors | 14-bit, 4398 billion colors | 14-bit, 4398 billion colors | Same. |
| Luminance
calibration | General calibration sensor | General calibration sensor | Same |
| Video Signal Input | | | |
| Input signals | Type-C×1,
Mini DP×1 | Type-C×2
HDMI×1 | The difference
only shows that
they have
different input,
has nothing to do
with the display
function. |
7
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences | | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Product | JUSHA-CP610 | CP620G LCD Monitor | | | |
| 510(k) Number | K200472 | K230643 | | | |
| Output signals | - | - | | | |
| Display
controller | Off the shelf | Off the shelf | Same | | |
| | | Power Related Specification | | | |
| Power
Requirement | AC 100240V 5060Hz | AC 100240V 5060Hz | Same | | |
| Power
Consumption/Sa
ve Mode | 15W / N/A | 20W/NA | The differences caused by components used in the LCD Monitor. This only shows the power consumption is different, nothing to do with the display function | | |
| Power
Management | NA | NA | Same | | |
| Miscellaneous Features/Specifications | | | | | |
| USB
Ports/standard | upstream (endpoint)/Rev.
3.1 | upstream (endpoint)/Rev.
3.1 | | | |
| Dimensions w/o
stand
(W×H×D) | 323mm×225×11.5mm | 312.3mm×220mm×11.5mm | Different housing design due to the different glass size. | | |
| Indication for
use | JUSHA-CP610 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 | CP620G/CP620 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 | CP620G/CP620 LCD Monitor is the display system with the high resolution (3000*2000), high luminance (500 cd/m2), and | | |
8
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | JUSHA-CP610 | CP620G LCD Monitor | |
| 510(k) Number | K200472 | K230643 | |
| Applicable
standard | 1 IEC 60601-1:2012, EN
60601-1:2013, ANSI/AAMI
ES60601-1:2005+A1:2012+
C1:2009+A2:2010,
CAN/CSA C22.2
NO.60601-1:14, Medical
equipment medical electrical
equipment - Part 1: General
requirements for basic safety
and essential performance.
2 IEC 60601-1-2 Edition
4:2014, EN 60601-1-2:2015,
Medical electrical equipment
- Part 1-2: General
requirements for basic safety
and essential performance -
Collateral standard:
Electromagnetic disturbances - Requirements and tests | 1 IEC 60601-1:2012, EN
60601-1:2013, ANSI/AAMI
ES60601-1:2005+A1:2012+
C1:2009+A2:2010,
CAN/CSA C22.2
NO.60601-1:14, Medical
equipment medical electrical
equipment - Part 1: General
requirements for basic safety
and essential performance.
2 IEC 60601-1-2 Edition
4:2014, EN 60601-1-2:2015,
Medical electrical equipment - Part 1-2: General
requirements for basic safety
and essential performance -
Collateral standard:
Electromagnetic disturbances - Requirements and tests | colors, can be
used in
displaying and
viewing digital
images for
diagnosis of
X-ray, MRI and
mammography,
etc.
Same |
| New Features | | | |
| Bidirectional
power supply
function | / | When one USB-C is
connected to the power
supply, it can power the
CP620 and reverse charge
the connected phone or
computer through the other
USB-C port | This is a new
feature of
CP620G that
makes using the
product more
convenient and
has nothing to do
with the display |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | JUSHA-CP610 | CP620G LCD Monitor | |
| 510(k) Number | K200472 | K230643 | |
| dual-screen
display function | / | With two inputs connected,
users can have a seamless
experience like a traditional
6MP medical monitor, two
independent 3MP window
side by side. | This is a new
feature
of
CP620G
that
makes using the
product
more
convenient. |
| gravity sensing
function | / | With build-in gravity sensor,
windows
will
rotate
automatically with
the
device orientation. | This is a new
feature
of
CP620G
that
makes using the
product
more
convenient and
has nothing to do
with the display
function. |
| Adaptive
environment
brightness
function | / | CP620G will monitor the
ambient light in real time,
and change brightness and
DICOM
compensation
accordingly, making it more
comfortable to do diagnosis
in different
lighting
environment | This is a new
feature
of
CP620G
that
makes using the
product
more
convenient. |
| Screen touch
function | / | The touch screen enables
users directly interact with
PACS and many more
software with fingers. Easier
and more intuitive | This is a new
feature
of
CP620G
that
makes using the
product
more
convenient and
has nothing to do
with the display
function. |
9
PERFORMANCE DATA:
The following performance data were provided in support of the substantial equivalence
10
determination.
Bench testing:
Bench testing was conducted to demonstrate the CP620/CP620G 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 .
- Measurement of the chromaticity non-uniformity characteristics of the display screen.
- 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 CP620G 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, CP620G, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
CP620G 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. The device should perform as intended in the specified use conditions. Naniing Jusha Display Technology Co., Ltd considers the CP620G Medical Display does not raise any new issues of safety or effectiveness.