(252 days)
Not Found
No
The description focuses on the display's technical specifications and calibration features, not on image analysis or interpretation using AI/ML.
No
The device is a monitor used for displaying and viewing digital medical images for review, analysis, and diagnosis, which is a diagnostic function, not a therapeutic one.
Yes
The intended use states that the device is for "displaying and viewing digital images... for review, analysis, and diagnosis by trained medical practitioners." This explicitly includes diagnosis as an intended function.
No
The device description explicitly lists hardware components such as an LCD panel, main board, power adapter, and data cable, in addition to software. Performance studies also focus on hardware characteristics like luminance and chromaticity.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "displaying and viewing digital images... for review, analysis, and diagnosis by trained medical practitioners." This describes a device used to present medical images to a healthcare professional for interpretation, not a device that performs tests on biological samples.
- Device Description: The description details a high-resolution LCD monitor with features designed for displaying medical images (DICOM standard LUT, brightness adaptation, etc.). It does not mention any components or processes related to analyzing biological samples.
- No mention of biological samples: The entire description focuses on the display of digital images and the technical specifications of the monitor. There is no mention of blood, tissue, urine, or any other biological material that would be the subject of an in vitro diagnostic test.
- Regulatory Classification: The mention of "Radiological 21CFR 892.2050" points towards a classification related to radiological devices, which are distinct from IVDs.
- Performance Studies: The performance studies described are focused on the display characteristics (luminance, uniformity, contrast, temporal response) and electrical safety/EMC, which are relevant to a medical display device, not an IVD.
In summary, an IVD is a device used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device is a display used to present medical images for interpretation by a medical professional.
N/A
Intended Use / Indications for Use
JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
Product codes
PGY
Device Description
JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is the display system with the high resolution (4200×2800), high luminance (800 cd/m²), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, JUSHA- C1210G has ambient brightness adapt inside. In particular, JUSHA- C1210G 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:
- 31" Color-TFT LCD Panel
- DMF2604AR0/main board/REV1.0
- JUSHA-C1210G 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, 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
Digital mammography, breast tomosynthesis
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 JUSHA-C1210G 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 TG18 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-C1210G 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-C1210G, does not require animal or clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
JUSHA JUSHA-M550G; K190848
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
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
March 25, 2022
Re: K212231
Trade/Device Name: C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: January 24, 2022 Received: January 24, 2022
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
1
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, Ph.D. Assistant Director Mammography Ultrasound and Imaging Software Branch 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
2
Indications for Use
510(k) Number (if known) K212231
Device Name C1210G/JUSHA-C1210G/C1210/JUSHA-C1210 LCD Monitor
Indications for Use (Describe)
JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, 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 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CER 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
K212231
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | May 26, 2021 |
|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd |
| Contact Person: | Add: 301, 8F Block A, No.1, Nanjing International Service |
| Outsourcing Mansion, Hanzhongmen Street,Nanjing, 210036 China |
Dongdong Li
Certification Manager
Nanjing Jusha Display Technology Co., Ltd
Tel: +86-25- 83305050
Fax: +86-25- 58783273 |
| Device Trade Name: | JUSHA-C1210G LCD Monitor, JUSHA-C1210 LCD Monitor,
C1210G LCD Monitor, C1210 LCD Monitor |
| Common/Usual Name: | 12MP Color LCD Monitor |
| Classification Name: | System, image processing, Radiological 21CFR 892.2050
PGY |
| Product Code: | |
| Predicate Device(s): | JUSHA JUSHA-M550G; K190848 |
| Device Description: | JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is the
display system with the high resolution (4200×2800), high
luminance (800 cd/m²), and 16-bit grayscale (65536 level), built-in
DICOM standard LUT. In particular, JUSHA- C1210G has ambient
brightness adapt inside. In particular, JUSHA- C1210G 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:
-
31" Color-TFT LCD Panel
-
DMF2604AR0/main board/REV1.0
-
JUSHA-C1210G LCD Monitor software
-
Power Adapter |
4
| - 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, | |||
| 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-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is | ||
| intended to be used in displaying and viewing digital images, | |||
| including standard and multi-frame digital mammography, for review, | |||
| analysis, and diagnosis by trained medical practitioners. It is specially | |||
| designed for displaying and viewing digital images, including | |||
| standard and multi-frame digital mammography, for review, analysis, | |||
| and diagnosis by trained medical practitioners. It is specially designed | |||
| for breast tomosynthesis applications. | |||
| Technology: | JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is the | ||
| display system with the high resolution ( $4200\times2800$ ), high | |||
| luminance (800 cd/m²), and 16-bit grayscale (65536 level), built-in | |||
| DICOM standard LUT. In particular, JUSHA- C1210G has ambient | |||
| brightness adapt inside. In particular, JUSHA- C1210G 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. | | |
5
| 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-C1210G is substantially equivalent to JUSHA JUSHA-
M550G. JUSHA-C1210G employs the maximum resolution values
larger than that of JUSHA-M550G. Comparison table of the principal
characteristics of 2 devices is shown in the 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 JUSHA-
C1210G LCD Monitor to be as safe, as effective, and performance is |
12.1 Product Comparison
6
This comparison identifies the similarities and differences of the proposed JUSHA-C1210G LCD Monitor device to the legally marketed predicate JUSHA JUSHA-M550G LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | JUSHA JUSHA-M550G | JUSHA-C1210G LCD
Monitor | |
| 510(k) Number | K190848 | / | |
| Display Performance/Specifications | | | |
| Screen
technology | 21.3inches, Mono-TFT LCD
Panel | 31inches, Color-TFT LCD
Panel | C1210G is larger
than M550G |
| Viewing angle
(H, V) | Horizontal 170°,Vertical
170° | Horizontal 178°,Vertical
178° | C1210G is better
than M550G |
| Resolution | $2560 \times 2048/2048 \times 2560$ | $4200\times2800$ | C1210G is larger
than M550G |
| Display area | $422.4(H)\times377.92(V)$ mm | $676.9(H)\times459.7(V)$ mm | C1210G is larger
than M550G |
| Contrast Ratio | 1700:1 | 1500:1 | C1210G is
smaller than
M550G, but the
difference does
not make
difference to the
diagnosis. |
| Supplied
CURVE | DICOM\CIE\GAMMA2.2\G
AMMA2.4 | DICOM\CIE\GAMMA2.2\G
AMMA2.4 | Same |
| DICOM
calibrated
luminance | 1000cd/m² | 800cd/m² | C1210G is
smaller than
M550G, and
both of them
meet the
requirements of
AAPM
regarding breast
diagnosis. |
| Pixel Pitch | $0.165\times0.165$ mm | $0.1554\times0.1554$ mm | C1210G is better
than M550G |
| Backlight | LED | LED | Same. |
| DICOM LUT | 16-bit:65536 | 16-bit:65536 | Same. |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | JUSHA JUSHA-M550G | JUSHA-C1210G LCD
Monitor | |
| 510(k) Number | K190848 | / | |
| 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 | DisplayPort 1.2a | The difference
only shows that
they have
different
input,has nothing
to do with the
display function. |
| Input
terminational | DVI-D×1,
DisplayPort×1 | DisplayPort×2 | The difference
only shows that
they have
different
input,has nothing
to do with the
display function. |
| Output signals | DisplayPort 1.2a | HDMI 2.0 | The difference
only shows that
they have
different output,
has nothing to do
with the display
function. |
| Output
Terminational | DisplayPort×1 | HDMI×1 | The difference
only shows that
they have
different output,
has nothing to do
with the display
function. |
| Display
controller | Off the shelf | Off the shelf | Same |
| Power Related Specification | | | |
| Power
Requirement | AC 100240V 5060Hz | AC 100240V 5060Hz | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | JUSHA JUSHA-M550G | JUSHA-C1210G LCD
Monitor | |
| 510(k) Number | K190848 | / | |
| Power
Consumption/Save Mode | 55W/less than 0.5W | 150W/less than 0.5W | 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 1.2a | DisplayPort 1.2a | The difference
only shows that
they have
different power
Management,
has nothing to do
with the display
function. |
| Miscellaneous Features/Specifications | | | |
| USB
Ports/standard | 1 upstream (endpoint),
2 downstream/ Rev. 2.0 | 1 upstream (endpoint),
2 downstream/ Rev. 3.0 | C1210G is better
than M550G. |
| Dimensions w/o
stand
(W×H×D) | Without stand:
$363mm×475mm×66mm$
With stand:
$363mm×635mm×238mm$ | Without stand:
$701.3 mm× 500 mm×$
86.8mm
With stand:
$701.3 mm× 589 mm×$
245mm | Different
housing design
due to the
different panel
size. |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | JUSHA JUSHA-M550G | JUSHA-C1210G LCD
Monitor | |
| 510(k) Number | K190848 | / | |
| 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 review,
analysis, and diagnosis by
trained medical practitioners.
It is specially de displaying
and viewing digital images,
including standard and
multi-frame digital
mammography, for review,
analysis, and diagnosis by
trained medical practitioners.
It is specially designed for
breast tomosynthesis
applications. | JUSHA-C1210G/JUSHA-
C1210/ C1210G/ C1210
LCD Monitor is intended to
be used in displaying and
viewing digital images,
including standard and
multi-frame digital
mammography, for review,
analysis, and diagnosis by
trained medical practitioners.
It is specially de displaying
and viewing digital images,
including standard and
multi-frame digital
mammography, for review,
analysis, and diagnosis by
trained medical practitioners.
It is specially designed for
breast tomosynthesis
applications. | Same |
7
8
9
10
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Product | JUSHA JUSHA-M550G | JUSHA-C1210G LCD
Monitor | |
| 510(k) Number | K190848 | / | |
| 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,
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 | 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 | 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 JUSHA-C1210G 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 TG18 guideline.
- Measurement of the chromaticity non-uniformity characteristics of the display . screen as specified in TG18 guideline.
- Measurement of small-spot contrast ratio. ●
11
- . 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-C1210G 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-C1210G, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
JUSHA-C1210G Medical Display is substantially equivalent to the predicate device with respect to technical characteristics, performance, application and intended use. The nonclinical 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-C1210G Medical Display does not raise any new issues of safety or effectiveness.