(63 days)
Not Found
No
The device description focuses on display technology and calibration features, with no mention of AI or ML for image analysis or interpretation.
No.
The device is a medical monitor used for displaying and viewing digital images for diagnosis, not for treating any condition or disease.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for view, and diagnosis by trained medical practitioners." The explicit mention of "diagnosis" indicates its role in the diagnostic process.
No
The device description explicitly lists hardware components such as an LCD Panel, Main Board, Power Adapter, and Data Cable, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to display and view digital images for diagnosis by trained medical practitioners. This is a function of medical imaging display, not a test performed on biological samples to diagnose a condition.
- Device Description: The device is a monitor, a display system. It does not contain reagents, assays, or components that interact with biological specimens.
- No mention of biological samples: The description focuses on displaying digital images, not analyzing biological samples like blood, urine, or tissue.
- Performance Studies: The performance studies described are related to the display's technical characteristics (luminance, contrast, uniformity) and electrical safety/EMC, not the accuracy or performance of a diagnostic test on biological samples.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to present existing medical images for interpretation, which is a different category of medical device.
N/A
Intended Use / Indications for Use
C510G/JUSHA-C510G/C510/JUSHA-C510 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for view, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
C510G/JUSHA-C510G/JUSHA-C510/C510 LCD Monitor is the display system with the high resolution (2560*2048), high luminance (1150 cd/m2), and 16-bit (65536 level), built-in DICOM standard LUT. In particular, C510G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, 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:
- 21.3" Color-TFT LCD Panel
- DMX0704AR1/Main Board/REV: 1.2
- C510G LCD Monitor software
- Power Adapter
- Data Cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
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 C510G meets all performance standards as follows:
- Measurement of the angular dependency of luminance response in horizontal, . vertical and diagonal directions
- Measurement of the luminance non-uniformity characteristics of the display . screen as specified in TGI18 guideline.
- Measurement of the chromaticity non-uniformity characteristics of the display . screen as specified in TG18 guideline.
- Measurement of small-spot contrast ratio. .
- Measurement of temporal response ●
- Performance data on luminance stability .
Electrical safety and EMC testing were conducted on the C510G The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): 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.
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 Donny Lee Certification Engineer 8A, Block 1. Nanjing International Service Outsourcing Mansion, No. 301 Hanzhongmen Street NANJING, JIANGSU 210036 CHINA
May 18, 2023
Re: K230723
Trade/Device Name: C510G/JUSHA-C510G/C510/JUSHA- C510 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 16, 2023 Received: March 16, 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
1
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 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. 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) K230723
Device Name C510G/JUSHA-C510G/C510/JUSHA-C510
Indications for Use (Describe)
C510G/JUSHA-C510G/C510/JUSHA-C510 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for view, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
| 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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3
510(k) Summary
(K230723)
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | March 16, 2023 |
|---|---|
| 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: | Donny Lee |
| Certification Manager | |
| Nanjing Jusha Display Technology Co., Ltd | |
| Tel: +86-25- 83305050 | |
| Fax: +86-25- 58783273 | |
| lidongdong@jusha.com.cn | |
| Device Trade Name: | C510G/JUSHA-C510G/C510/JUSHA-C510 LCD Monitor |
| Common/Usual Name: | 5MP Color LCD Monitor |
| Classification Name: | Medical image management and processing system 21CFR 892.2050 PGY |
| Product Code: | JUSHA-M550G; K190848 |
| Predicate Device(s): | JUSHA-M550G; K190848 |
| Device Description: | C510G/JUSHA-C510G/JUSHA-C510/C510 LCD Monitor is the display system with the high resolution (2560*2048), high luminance (1150 cd/m2), and 16-bit (65536 level), built-in DICOM standard LUT. In particular, C510G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, 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: |
- 21.3" Color-TFT LCD Panel
- DMX0704AR1/Main Board/REV: 1.2
- C510G LCD Monitor software |
4
| - 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, 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. | ||||
| Intended Use: | C510G/JUSHA-C510G/JUSHA-C510/C510 LCD Monitor is intended | |||
| to be used in displaying and viewing digital images, including | ||||
| standard and multi-frame digital mammography, for view, analysis, | ||||
| and diagnosis by trained medical practitioners. It is specially designed | ||||
| for breast tomosynthesis applications. | ||||
| Technology: | C510G/JUSHA-C510G/JUSHA-C510/C510 LCD Monitor is the | |||
| display system with the high resolution (2560*2048), high luminance | ||||
| (1150 cd/m2), and 16-bit grayscale (65536 level), built-in DICOM | ||||
| standard LUT. In particular, C510G has ambient brightness adapting, | ||||
| real-time DICOM automatic calibration, full-screen brightness | ||||
| equalization and presence induction system, 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: | | | |
| | C510G is substantially equivalent to JUSHA-M550G. C510G
employs the maximum resolution values same as that of JUSHA-
M550G.
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 C510G
LCD Monitor to be as safe, as effective, and performance is
substantially equivalent to the predicate device JUSHA-M550G. | | | |
5
Product Comparison
This comparison identifies the similarities and differences of the proposed C510G LCD Monitor device to the legally marketed predicate JUSHA-M550G LCD Monitor device to which substantial equivalency is claimed.
6
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | JUSHA-M550G LCD
Monitor | C510G LCD Monitor | |
| 510(k) Number | K190848 | K230723 | |
| | | Display Performance/Specifications | |
| Screen
technology | 21.3inches, Mono-TFT LCD
Panel | 21.3inches, Color-TFT LCD
Panel | Same |
| Viewing angle
(H, V) | Horizontal 178°,
Vertical 178° | Horizontal 178°,
Vertical 178° | Same |
| Resolution | 2560 x 2048/2048x 2560 | 2560 x2048/2048x 2560 | Same |
| Display area | 422.4(H) x 377.9 (V) mm | 422.4(H) x337.9 (V) mm | The two
monitors have
different front
frame style while
the M550G
employ a Slim
Bezel design so
that the display
area is different. |
| Contrast Ratio | 1700:1 | 2000:1 | C510G has
better contrast
ratio for the
panel, while the
difference does
not make
difference to the
diagnosis. |
| DICOM
calibrated
luminance | 1000cd/m2 | 500cd/m2 | The two models
have different
panels with
different
brightness but
they have the
same resolution
for 5MP for
Mammo image
diagnosis. |
| Pixel Pitch | 0.165x0.165 mm | 0.165x0.165 mm | Same |
| Backlight | LED | LED | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | JUSHA-M550G LCD
Monitor | C510G LCD Monitor | Same |
| 510(k) Number | K190848 | K230723 | Same |
| DICOM LUT | 16-bit: 65536 | 16-bit: 65536 | Same |
| Luminance
calibration | Built in calibration sensor
provided | Built in calibration sensor
provided | Same |
| Video Signal Input | | | |
| Input signals | DVI standard 1.0,
DisplayPort 1.2a | DVI standard 1.0,
DisplayPort 1.2a | Same |
| Input
terminational | DVI-D x 1,
DisplayPort x 1 | DVI-D x 1,
DisplayPort x 1 | Same |
| Output signals | DisplayPort 1.2a | DisplayPort 1.2a | Same |
| Output | DisplayPort x 1 | DisplayPort x 1 | Same |
| Terminational
Display
controller | Off the shelf | Off the shelf | Same |
| Power Related Specification | | | |
| Power
Requirement | DC 24V | DC 24V | Same |
| Power
Consumption/Sa
ve Mode | 55W/less than 0.5W | 55W/less than 0.5W | Same |
| Power
Management | DVI DMPM
DisplayPort 1.2a | DVI DMPM
DisplayPort 1.2a | Same |
| Miscellaneous Features/Specifications | | | |
| USB
Ports/standard | 1 upstream (endpoint),
2 downstream/ Rev. 2.0 | 1 upstream (endpoint),
2 downstream/ Rev. 2.0 | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of Differences |
| Product | JUSHA-M550G LCD Monitor | C510G LCD Monitor | |
| 510(k) Number | K190848 | K230723 | |
| Dimensions w/o stand
(W x H x D) | Without stand:
363mm x475mm x66mm
With stand:
363mm x522mm x238mm | Without stand:
399mm x491mm x74mm
With stand:
399mm x530mm x238mm | Different Dimensions design due to the different structure size. |
| Indication for use | JUSHA-M550G/JUSHA-
M550/M550G/M550 LCD
Monitor is intended to be
used in displaying and
viewing digital images,
including standard and
multi-frame digital
mammography, for view,
analysis, and diagnosis by
trained medical practitioners.
It is specially designed for
breast tomosynthesis
applications. | C510G/JUSHA-
C510G/C510/JUSHA-C510
LCD Monitor is intended to
be used in displaying and
viewing digital images,
including standard and
multi-frame digital
mammography, for view,
analysis, and diagnosis by
trained medical practitioners.
It is specially designed for
breast tomosynthesis
applications. | Same |
7
8
9
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Product | JUSHA-M550G LCD
Monitor | C510G LCD Monitor | |
| 510(k) Number | K190848 | K230723 | |
| 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 | Same |
PERFORMANCE DATA:
The following performance data were provided in support of the substantial equivalence determination.
Bench testing:
Bench testing was conducted to demonstrate the C510G 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 ●
10
- Performance data on luminance stability .
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the C510G 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, C510G, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
C510G 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 C510G Medical Display does not raise any new issues of safety or effectiveness.