(85 days)
C630G, K222121
Not Found
No
The description focuses on display technology features like resolution, luminance, grayscale, and calibration, without mentioning AI/ML algorithms for image analysis or processing. The performance studies are related to display characteristics, not AI/ML model performance.
No
The device is a medical monitor intended for displaying diagnostic images, not for delivering therapy.
Yes
This device is intended to be used in displaying digital images for the diagnosis of X-ray or MRI by trained medical practitioners, which clearly indicates its role in a diagnostic process.
No
The device description explicitly lists multiple hardware components, including the display, graphic card, cables, and power supply. The performance studies also focus on hardware characteristics like luminance, contrast, and electrical safety.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to display digital images from modalities like X-ray and MRI for diagnosis by trained medical practitioners. This is related to medical imaging, not the examination of specimens derived from the human body.
- Device Description: The device is a monitor designed for displaying medical images with specific characteristics like high resolution, luminance, and grayscale. It does not involve any reagents, instruments, or systems used for the examination of specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in the body, or providing information about a patient's health status based on laboratory tests.
IVDs are specifically designed to perform tests on biological samples (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is solely to display images generated by other medical equipment.
N/A
Intended Use / Indications for Use
C660G/C810G LCD Monitor is intended to be used in displaying digital images diagnosis of X-ray or MRI.etc.by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
JUSHA-C660G/JUSHA-C660/C660G/C660 LCD Monitor is the display system with high resolution (3280×2048), high luminance (800 cd/m2), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, C660G has ambient brightness adaptation inside, on top of which C660G has real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, therefore this display automatically adjust according to different requirements to achieve the best results.
The product is consisted of the following components:
- the display with stand
- a graphic card
- agraphic card driver CD
- an AC power cable
- an external power supply
- a Type-C cable
- Three DP cables
- a USB cable
JUSHA-C810G/ C810G LCD Monitor is the display system with high resolution (3840×2160), high luminance (800 cd/m2), and 14-bit grayscale (16384 grayscale), built-in DICOM standard LUT. In particular, C810G has ambient brightness adaptation inside, on top of which C810G has real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, therefore this display automatically adjust according to different requirements to achieve the best results.
The product is consisted of the following components:
- the display with stand
- a graphic card
- agraphic card driver CD
- an AC power cable
- an external power supply
- a DVI cable
- two Mini DP switch to DP cable
- a USB cable
The LCD Monitors are 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
X-ray or MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted to demonstrate the C660G/C810G 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 C660G/C810G. 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, C660G/C810G, 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.
C630G, K222121
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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
June 9, 2023
Re: K230728
Trade/Device Name: JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA- C660G/C660/C660G 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.
1
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 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.
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) K230728
Device Name
JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor
Indications for Use (Describe)
C660G/C810G LCD Monitor is intended to be used in displaying digital images 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) | |
|---|---|
|X 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
(K230728)
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | Mar 16, 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 | |
| lidongdong@jusha.com.cn | |
| Device Trade Name: | JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA- |
| C660G/C660/C660G LCD Monitor | |
| Common/Usual Name: | 6MP/8MP Color LCD Monitor |
| Classification Name: | Medical Image Management and Processing System 21CFR 892.2050 |
| Product Code: | PGY |
| Predicate Device(s): | C630G, K222121 |
| Device Description: | JUSHA-C660G/JUSHA-C660/C660G/C660 LCD Monitor is the |
| display system with high resolution (3280×2048), high luminance (800 | |
| cd/m2), and 16-bit grayscale (65536 level), built-in DICOM standard | |
| LUT. In particular, C660G has ambient brightness adaptation inside, | |
| on top of which C660G has real-time DICOM automatic calibration, | |
| full-screen brightness equalization and presence induction system, | |
| therefore this display automatically adjust according to different | |
| requirements to achieve the best results. |
The product is consisted of the following components:
- the display with stand
- a graphic card |
| | - agraphic card driver CD |
| | - an AC power cable |
| | - an external power supply |
| | - a Type-C cable |
| | - Three DP cables |
| | - a USB cable |
| | JUSHA-C810G/ C810G LCD Monitor is the display system with high resolution (3840×2160), high luminance (800 cd/m2), and 14-bit grayscale (16384 grayscale), built-in DICOM standard LUT. In particular, C810G has ambient brightness adaptation inside, on top of which C810G has real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, therefore this display automatically adjust according to different requirements to achieve the best results. |
| | The product is consisted of the following components: |
| | - the display with stand |
| | - a graphic card |
| | - agraphic card driver CD |
| | - an AC power cable |
| | - an external power supply |
| | - a DVI cable |
| | - two Mini DP switch to DP cable |
| | - a USB cable |
| | |
| | The LCD Monitors are 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.
- 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: | C660G/C810G 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-C660G/JUSHA-C660/C660G/C660 LCD Monitor is the
display system with high resolution (3280×2048), high luminance (800
cd/m2), and 16-bit grayscale (65536 level), built-in DICOM standard
LUT. In particular, C660G has ambient brightness adaptation inside,
on top of which C660G has real-time DICOM automatic calibration,
full-screen brightness equalization and presence induction system,
therefore this display automatically adjust according to different
requirements to achieve the best results.
JUSHA-C810G/ C810G LCD Monitor is the display system with high
resolution (3840×2160), high luminance (800 cd/m2), and 14-bit
grayscale (16384 grayscale), built-in DICOM standard LUT. In
particular, C810G has ambient brightness adaptation inside, on top of
which C810G has real-time DICOM automatic calibration, full-screen
brightness equalization and presence induction system, therefore this
display automatically adjust according to different requirements
to
achieve the best results. |
| Determination of Substantial
Equivalence: | Summary of Non-Clinical Tests:
The LCD Monitor(C660G,C810G) 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 |
| | C660G/C810G LCD Monitor are substantially equivalent to C630
LCD Monitor. They have equivalent characteristics andfunctions
according to comparison table, pleaserefer to 12. 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
C660G/C810G LCD Monitor to be as safe, as effective, and
performance is substantially equivalent to the predicate device(s) |
4
5
6
12.1 Product Comparison
This comparison identifies the similarities and differences of the proposed C660G/C810G LCD Monitor device to the legally marketed predicate C630 LCD Monitor device to which substantial equivalency is claimed.
7
| Attributes | Predicate Device | Proposed Device | Discussion of Differences | |
|---|---|---|---|---|
| Display Performance/Specifications | ||||
| Product | C630G LCD | |||
| Monitor | C660G LCD | |||
| Monitor | C810G LCD | |||
| Monitor | ||||
| 510(k) Number | K222121 | K230728 | ||
| Screen | ||||
| technology | 30 inches, Color-TFT LCD Panel | 30inches,Color-TFT LCD Panel | 31.5inches, | |
| Color-TFT LCD | ||||
| Panel | C660G and | |||
| C630G are | ||||
| same, C810G is | ||||
| larger than | ||||
| C630G. | ||||
| Viewing angle | ||||
| (H, V) | Horizontal | |||
| 178°, Vertical | ||||
| 178° | Horizontal | |||
| 178°, Vertical 178° | Horizontal | |||
| 178°, Vertical | ||||
| 178° | Same | |||
| Resolution | 3280x2048 | 3280x2048 | 3840x2160 | C660G and |
| C630G are | ||||
| same, C810G is | ||||
| better than | ||||
| C630G. | ||||
| Display area | 645.5 (H) mm × | |||
| 403 (V)mm | 645.5 (H) mm × | |||
| 409.3 (V)mm | 697.31(H) mm× | |||
| 392.23(V)mm | C660G and | |||
| C630G are | ||||
| same, C810G is | ||||
| larger than | ||||
| C630G. | ||||
| Contrast Ratio | 1000:1 | 2000:1 | 1300:1 | C660G and |
| C810G are larger | ||||
| than C630G. | ||||
| DICOM | ||||
| calibrated | ||||
| luminance | 500cd/m² | 800 cd/m² | 1000cd/m² | C660G and |
| C810G are larger | ||||
| than C630G. | ||||
| Pixel Pitch | 0.197mm× | |||
| 0.197mm | 0.197mm× | |||
| 0.197mm | 0.1816mm× | |||
| 0.1816mm | C660G and | |||
| C630G are | ||||
| same, C810G is | ||||
| better than | ||||
| C630G. | ||||
| Backlight | LED | LED | LED | Same. |
| Attributes | Predicate Device | Proposed Device | Discussion of Differences | |
| Product | C630G LCD | |||
| Monitor | C660G LCD | |||
| Monitor | C810G LCD | |||
| Monitor | ||||
| 510(k) Number | K222121 | K230728 | ||
| DICOM LUT | 16-bit:65536 | 16-bit:65536 | 14-bit:16384 | This parameter is an output |
| range.C810G is smaller than | ||||
| them, But the three products | ||||
| can only output 10bit images. | ||||
| Luminance | ||||
| calibration | Built in | |||
| calibration | ||||
| sensor provided | Built in calibration | |||
| sensor provided | Built in | |||
| calibration | ||||
| sensor provided | Same. | |||
| Video Signal Input | ||||
| Input signals | DisplayPort 1.2a | |||
| DVI | DisplayPort 1.2a | |||
| Type-C | ||||
| DVI | DisplayPort 1.2a | |||
| DVI | The difference | |||
| only shows that | ||||
| they have | ||||
| different | ||||
| input,has nothing | ||||
| to do with the | ||||
| display function. | ||||
| Input | ||||
| terminational | DisplayPort×2 | |||
| DVI×1 | DisplayPort×2 | |||
| Type-C | ||||
| DVI×1 | DisplayPort×2 | |||
| DVI×1 | The difference | |||
| only shows that | ||||
| they have | ||||
| different | ||||
| input,has nothing | ||||
| to do with the | ||||
| display function. | ||||
| Output signals | DisplayPort 1.2a | DisplayPort 1.2a | NA | C660G and |
| C630G are | ||||
| same, C810G | ||||
| has no output | ||||
| interface. | ||||
| Output | ||||
| Terminational | DisplayPort×1 | DisplayPort×1 | NA | C660G and |
| C630G are | ||||
| same, C810G | ||||
| has no output | ||||
| interface. | ||||
| Display | ||||
| controller | Off the shelf | Off the shelf | Off the shelf | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of Differences | |
| Product | C630G LCD Monitor | C660G LCD Monitor | C810G LCD Monitor | |
| 510(k) Number | K222121 | K230728 | ||
| Power Related Specification | ||||
| Power Requirement | 24VDC-9.2A | 24VDC-6.25A | 24V 5A | Same |
| Power Consumption/Save Mode | 150W/less than 0.5W | 150W/less than 0.5W | 120W/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 | DisplayPort 1.2a | DisplayPort 1.2a | 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 | 1 upstream (endpoint), | |||
| 2 downstream/ Rev. 2.0 | Same | |||
| Dimensions w/o stand (W×H×D) | Without stand: | |||
| 701.3 mm× 500 mm× 86.8mm | ||||
| With stand: | ||||
| 701.3 mm× 589 mm× 245mm | Without stand: | |||
| 721.5 mm× 493.5 mm× 110mm | ||||
| With stand: | ||||
| 721.5 mm× 585 mm× 262mm | Without stand: | |||
| 756.7 mm× 464.2 mm× 70.2mm | ||||
| With stand: | ||||
| 756.7 mm× 556.7 mm× 262mm | Different housing design due to the different glass size. | |||
| Attributes | Predicate Device | Proposed Device | Discussion of Differences | |
| Product | C630G LCD | |||
| Monitor | C660G LCD | |||
| Monitor | C810G LCD | |||
| Monitor | ||||
| 510(k) Number | K222121 | K230728 | ||
| Indication for use | JUSHA- | |||
| C630G/JUSHA- | ||||
| C630/C630G/C6 | ||||
| 30 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. | C660G/C810G 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 |
8
9
10
11
| Applicable
| standard | |||
|---|---|---|---|
| 1 IEC 60601- | |||
| 1:2012, EN | |||
| 60601-1:2013, | |||
| ANSI/AAMI | |||
| ES60601- | |||
| 1:2005+A1:2012 | |||
| +C1:2009+A2:20 | |||
| 10, CAN/CSA | |||
| C22.2 | |||
| NO.60601-1:14, | |||
| Medical | |||
| equipment | |||
| medical electrical | |||
| equipment - Part | |||
| 1: General | |||
| requirements for | |||
| basic safety and | |||
| essential | |||
| performance. | 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. | Same | ||
| 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 | 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 |
12
PERFORMANCE DATA:
The following performance data were provided in support of the substantial equivalence determination.
Bench testing:
Bench testing was conducted to demonstrate the C660G/C810G 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 C660G/C810G 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, C660G/C810G, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
C660G/C810G LCD Monitor is substantially equivalent to the predicate device with respect to technical characteristics, performance, application and intended use. The non-clinical data support the safety of the device should perform as intended in the specified use conditions. Nanjing Jusha Display Technology Co., Ltd considers the C660G/C810G Medical Display does not raise any new issues of safety or effectiveness.