(123 days)
JUSHA-C61; K141679
No
The document describes a medical display monitor with standard features like high resolution, luminance, and DICOM LUT. It mentions "automatic adjustment according to different requirements" and "color bit expansion technology" for image quality improvement, but these are not indicative of AI/ML. There is no mention of AI, ML, deep learning, or related terms, nor any description of training or test data sets typically associated with AI/ML models.
No
Explanation: The device is described as an LCD monitor intended for displaying and viewing digital images for diagnosis. It does not perform any therapeutic function like treating or mitigating a disease or condition.
Yes
The device is described as "intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners." This explicitly states its purpose in diagnosis.
No
The device description explicitly lists hardware components such as an LCD panel, a board, a power adapter, and a data cable, in addition to software.
Based on the provided information, the JUSHA-CP610 LCD Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "displaying and viewing digital images for diagnosis of X-ray or MRI, etc." 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 monitor (resolution, luminance, color, DICOM support) and its components. It does not mention any components or functionalities related to analyzing biological samples.
- Lack of IVD Characteristics: IVD devices are designed to perform tests on biological samples (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. This device does not perform any such tests.
- Standards Compliance: The listed standards (IEC 60601-1, IEC 60601-1-2) are general standards for medical electrical equipment, not specific standards for IVD devices.
In summary, the JUSHA-CP610 LCD Monitor is a medical device used for displaying medical images, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
JUSHA-CP610 LCD Monitor, CP610 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
PGY
Device Description
JUSHA-CP610/CP610 LCD Monitor is the display system with the high resolution (3000*2000), high luminance (300 cd/m²), and 4398 billion colors, built-in DICOM standard LUT. In particular, JUSHA-CP610 LCD Monitor is portable and light, the 850g 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.
The product is consisted of the following components:
- 13.5" Color TFT LCD Panel
- DMS0600A board/4 layer/233*127mm/1.0mm/REV:1.1
- JUSHA-CP610 LCD Monitor software
- Power Adapter
- Data Cable.
The software that supports the functions of the CP610 is the same as the software used with the predicate JUSHA C61. The level of concern was determined to be Moderate for the JUSHA-CP610 LCD Monitor.
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, CFR 47 FCC Part15 subpart B: 2017, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
Mentions image processing
Yes
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
Bench testing was conducted to demonstrate the JUSHA-CP610 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-CP610 The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
Key Metrics
Not Found
Predicate Device(s)
JUSHA-C61; K141679
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).
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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" in a larger font and the word "Administration" in a smaller font.
July 24, 2020
Nanjing Jusha Display Technology Co., Ltd. % Mr. Zilong Liang Certification Manager Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St. Nanjing, Jiangsu 210036 CHINA
Re: K200742
Trade/Device Name: JUSHA-CP610 LCD Monitor, CP610 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: July 1, 2020 Received: July 1, 2020
Dear Mr. Zilong Liang:
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 mediation-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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200742
Device Name JUSHA-CP610 LCD Monitor, CP610 LCD Monitor
Indications for Use (Describe)
JUSHA-CP610 LCD Monitor, CP610 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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
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510(k) Summary
K200742
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | September 23, 2019 |
|---|---|
| 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- 58783273 | |
| Device Trade Name: | JUSHA-CP610 LCD Monitor, CP610 LCD Monitor |
| Common/Usual Name: | 6MP Color LCD Monitor |
| Classification Name: | Display, Diagnostic Radiology 21CFR 892.2050 |
| Product Code: | PGY |
| Regulatory name: | Picture Archiving and Communications System |
| Regulatory Class: | Class II |
| Predicate Device(s): | JUSHA-C61; K141679 |
| Classification Name: Display, Diagnostic Radiology 21CFR 892.2050 | |
| Product Code: PGY | |
| Regulatory name: Picture Archiving and Communications System | |
| Regulatory Class: Class II | |
| Device Description: | JUSHA-CP610/CP610 LCD Monitor is the display system with the high |
| resolution (3000*2000), high luminance (300 cd/m²), and 4398 billion | |
| colors, built-in DICOM standard LUT. In particular, JUSHA-CP610 LCD | |
| Monitor is portable and light, the 850g 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. | |
| The product is consisted of the following components: |
- 13.5" Color TFT LCD Panel
- DMS0600A board/4 layer/233*127mm/1.0mm/REV:1.1
- JUSHA-CP610 LCD Monitor software
- Power Adapter
- Data Cable.
The software that supports the functions of the CP610 is the same as the
software used with the predicate JUSHA C61. The level of concern was
determined to be Moderate for the JUSHA-CP610 LCD Monitor.
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, CFR 47 FCC Part15 subpart B: 2017, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests. |
| Intended Use: | JUSHA-CP610/CP610 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-CP610/CP610 LCD Monitor is the display system with the high resolution (3000*2000), high luminance (300 cd/m²), and 4398 billion colors, built-in DICOM standard LUT. In particular, JUSHA-CP610 LCD Monitor is portable and light, the 850g 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, CFR 47 FCC Part15 subpart B: 2017, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
JUSHA-CP610 /CP610 LCD Monitor is substantially equivalent to JUSHA-C61. JUSHA-CP610 LCD/CP610 LCD Monitor employs the maximum resolution values same as that of JUSHA-C61. At a high level, the subject and predicate devices are based on the following same technological elements:
• Maximum resolution: 6megapixels
• Screen technology: Color TFT LCD Panel
• Viewing angle: Horizontal 170°,Vertical 170°
• LED Backlight
• Intended Use
• Software function: DICOM calibration function and The host computer communication. |
| predicate devices: | |
| • | Screen Size: The subject device uses a smaller screen size to reduce weight and improve the portability. |
| • | Display Colors: The subject device uses a color bit expansion technology to improve image display quality, the image clarity is better than the image displayed on the predicate device. |
| • | Software function: The new functions Grayscale expansion and Signal scanning and switching module were used in the subject device. |
| 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 JUSHA-CP610 LCD Monitor to be as safe, as effective, and performance is substantially equivalent to the predicate device(s). |
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12.1 Product Comparison
This comparison identifies the similarities and differences of the proposed JUSHA-CP610 LCD Monitor device to the legally marketed predicate JUSHA-C61 LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | JUSHA-C61 | JUSHA-CP610 | |
| 510(k) Number | K141679 | / | |
| Display Performance/Specifications | | | |
| Screen technology | 30" Color TFT LCD Panel | 13.5" Color TFT LCD Panel | The
JUSHA-CP610
LCD Monitor
uses a smaller
LCD Panel to
reduce weight
and improve
the portability of
the device. |
| Viewing angle
(H, V) | Horizontal 170°,Vertical
170° | Horizontal 170°,Vertical
170° | Same |
| Resolution | $3280×2048$ | $3000×2000$ | This difference
between the two
devices is caused
by the LCD
Panel, and the
JUSHA CP610
LCD Monitor
could also meet
the requirement
of 6megapixels. |
| Display area | 403.0(V) ×645.5(H) mm | 285.3(V)×190.2(H)mm | - |
| Contrast Ratio | 1000:1 | 1800:1 | - |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | JUSHA-C61 | JUSHA-CP610 | |
| 510(k) Number | K141679 | / | |
| Scanning
frequency (H; V) | 5276kHz; 5961Hz | 94.94123.84kHz; 60Hz | This difference240V 50
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 | 300cd/m² | This difference
between the two
devices is caused
by factory
setting, nothing
to do with the
display function |
| Pixel Pitch | 0.197×0.197 mm | 0.0951×0.0951mm | The
JUSHA-CP610
LCD uses a
smaller Pixel
Pitch to improve
the pixel density. |
| Backlight | LED | LED | Same. |
| Display Colors | 12-bit , 68.7 billion colors | 14-bit, 4398 billion colors | The
JUSHA-CP610
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. |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | JUSHA-C61 | JUSHA-CP610 | |
| 510(k) Number | K141679 | / | |
| Luminance
calibration | Built in calibration sensor
provided | General calibration sensor | The JUSHA
CP610 LCD
Monitor use the
general sensor to
instead the
build-in sensor
to reduce weight
and improve the
portability of the
device |
| Video Signal Input | | | |
| Input signals | DVI-D Dual Link x2
Display Port x2 | Type-C×1,
Mini DP×1 | - |
| Output signals | - | - | - |
| Display
controller | Off the shelf | Off the shelf | Same |
| Power Related Specification | | | |
| Power
Requirement | AC 10060Hz | AC 100240V 50~60Hz | Same |
| Power
Consumption/Save Mode | 100W/less than 1.5W | 15W / N/A | 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 | DVI DMPM
DisplayPort 1.1a | N/A | - |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | JUSHA-C61 | JUSHA-CP610 | |
| 510(k) Number | K141679 | / | |
| USB
Ports/standard | 1 upstream (endpoint),
2 downstream/ Rev. 2.0 | upstream (endpoint)/Rev.
3.1 | - |
| Dimensions (W x H x D) | Without stand:
704mm x 478mm x 81mm
With stand:
704mm x 611mm x292mm | 323mm×225×11.5mm | Different
housing design
due to the
different panel
size. |
| Indication for
use | JUSHA-C61 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. | JUSHA-CP610 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 |
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10
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Product | JUSHA-C61 | JUSHA-CP610 | / |
| 510(k) Number | K141679 | / | |
| 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, 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,
CFR 47 FCC Part15 subpart
B: 2017, Medical electrical
equipment - Part 1-2:
General requirements for
basic safety and essential
performance - Collateral
standard: Electromagnetic
disturbances - Requirements
and tests. | - |
11
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-CP610 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-CP610 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-CP610, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
JUSHA-CP610 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. Nanjing Jusha Display Technology Co., Ltd considers the JUSHA-CP610 Medical Display does not raise any new issues of safety or effectiveness.