(85 days)
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.
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.
The provided document describes the FDA 510(k) premarket notification for the JUSHA-C810G/C810G LCD Monitor and JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor. These are medical image display systems.
The acceptance criteria for this device are based on its performance specifications and compliance with recognized standards, demonstrating substantial equivalence to a legally marketed predicate device (C630G, K222121).
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison table against a predicate device, which indicates the performance criteria and how the proposed devices (C660G and C810G) compare. The acceptance criteria are implicitly those of the predicate device and relevant industry standards.
| Attribute | Acceptance Criteria (Predicate C630G) | Reported Device Performance (Proposed C660G LCD Monitor) | Reported Device Performance (Proposed C810G LCD Monitor) |
|---|---|---|---|
| Display Performance/Specifications | |||
| Screen technology | 30 inches, Color-TFT LCD Panel | 30 inches, Color-TFT LCD Panel | 31.5 inches, Color-TFT LCD Panel |
| Viewing angle (H, V) | Horizontal 178°, Vertical 178° | Horizontal 178°, Vertical 178° | Horizontal 178°, Vertical 178° |
| Resolution | 3280x2048 | 3280x2048 | 3840x2160 |
| 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 |
| Contrast Ratio | 1000:1 | 2000:1 | 1300:1 |
| DICOM calibrated luminance | 500cd/m² | 800 cd/m² | 1000cd/m² |
| Pixel Pitch | 0.197mm × 0.197mm | 0.197mm × 0.197mm | 0.1816mm × 0.1816mm |
| Backlight | LED | LED | LED |
| DICOM LUT | 16-bit:65536 | 16-bit:65536 | 14-bit:16384 (outputs 10-bit images) |
| Luminance calibration | Built in calibration sensor provided | Built in calibration sensor provided | Built in calibration sensor provided |
| Video Signal Input | |||
| Input signals | DisplayPort 1.2a, DVI | DisplayPort 1.2a, Type-C, DVI | DisplayPort 1.2a, DVI |
| Input terminational | DisplayPort × 2, DVI × 1 | DisplayPort × 2, Type-C, DVI × 1 | DisplayPort × 2, DVI × 1 |
| Output signals | DisplayPort 1.2a | DisplayPort 1.2a | NA |
| Output Terminational | DisplayPort × 1 | DisplayPort × 1 | NA |
| Display controller | Off the shelf | Off the shelf | Off the shelf |
| Power Related Specification | |||
| Power Requirement | 24VDC-9.2A | 24VDC-6.25A | 24V 5A |
| Power Consumption/Save Mode | 150W/less than 0.5W | 150W/less than 0.5W | 120W/less than 0.5W |
| Power Management | DisplayPort 1.2a | DisplayPort 1.2a | DisplayPort 1.2a |
| 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 |
| Indication for use | Same as proposed devices | 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 as C660G |
| Applicable Standards | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states that no clinical studies were required to support substantial equivalence for this device (medical image display monitors). The testing performed was "Bench testing" and "Electrical safety and electromagnetic compatibility (EMC) testing" on the physical devices themselves. Therefore, there is no "test set" in the context of clinical data, no sample size of patients/cases, and no data provenance from patients/cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As noted above, no clinical studies with expert-established ground truth were performed or required for this device type. The performance evaluation relied on engineering bench testing and compliance with recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring expert adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a display monitor, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-assistance comparison was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a display monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for evaluating this device's performance is objective technical specifications and compliance with international standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2) and display performance (TG18 guideline).
8. The sample size for the training set
Not applicable. This device is a display monitor and does not involve machine learning algorithms requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set.
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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 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.
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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
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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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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., LtdAdd: 8A, Block 1. Nanjing International Service OutsourcingMansion, No. 301, Hanzhongmen street, Nanjing City, JiangsuProvince, 210036 China. |
| Contact Person: | Donny LeeCertification EngineerNanjing Jusha Display Technology Co., LtdTel: +86-25- 83305050Fax: +86-25- 58783273lidongdong@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 thedisplay system with high resolution (3280×2048), high luminance (800cd/m2), and 16-bit grayscale (65536 level), built-in DICOM standardLUT. 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 differentrequirements 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/AAMIES60601-1:2005+A1:2012+C1:2009+A2:2010,CAN/CSA C22.2 NO.60601-1:14, Medical equipmentmedical electrical equipment - Part 1: Generalrequirements 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: Generalrequirements 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 andviewing digital images for diagnosis of X-ray or MRI, etc. by trainedmedical practitioners. The device does not support the display ofmammography images for diagnosis. |
| Technology: | JUSHA-C660G/JUSHA-C660/C660G/C660 LCD Monitor is thedisplay system with high resolution (3280×2048), high luminance (800cd/m2), and 16-bit grayscale (65536 level), built-in DICOM standardLUT. 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 differentrequirements to achieve the best results.JUSHA-C810G/ C810G LCD Monitor is the display system with highresolution (3840×2160), high luminance (800 cd/m2), and 14-bitgrayscale (16384 grayscale), built-in DICOM standard LUT. Inparticular, C810G has ambient brightness adaptation inside, on top ofwhich C810G has real-time DICOM automatic calibration, full-screenbrightness equalization and presence induction system, therefore thisdisplay automatically adjust according to different requirementstoachieve the best results. |
| Determination of SubstantialEquivalence: | Summary of Non-Clinical Tests:The LCD Monitor(C660G,C810G) complies with voluntary standardsas following:1 IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2NO.60601-1:14, Medical equipment medical electrical equipment- Part 1: General requirements for basic safety and essentialperformance. |
| 2 | IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, Medicalelectrical equipment - Part 1-2: General requirements for basicsafety and essential performance - Collateral standard:Electromagnetic disturbances - Requirements and tests |
| C660G/C810G LCD Monitor are substantially equivalent to C630LCD Monitor. They have equivalent characteristics andfunctionsaccording to comparison table, pleaserefer to 12. Product Comparison | |
| The following quality assurance measures were applied to thedevelopment 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 notrequire clinical studies to support substantial equivalence. | |
| The proposed device is Substantially Equivalent (SE) to the predicatedevice which is US legally market device. Therefore, the subjectdevice is determined as safe and effectiveness. | |
| Conclusion: | Nanjing Jusha Display Technology Co., Ltd Considers theC660G/C810G LCD Monitor to be as safe, as effective, andperformance 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 C660G/C810G LCD Monitor device to the legally marketed predicate C630 LCD Monitor device to which substantial equivalency is claimed.
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| Attributes | Predicate Device | Proposed Device | Discussion of Differences | |
|---|---|---|---|---|
| Display Performance/Specifications | ||||
| Product | C630G LCDMonitor | C660G LCDMonitor | C810G LCDMonitor | |
| 510(k) Number | K222121 | K230728 | ||
| Screentechnology | 30 inches, Color-TFT LCD Panel | 30inches,Color-TFT LCD Panel | 31.5inches,Color-TFT LCDPanel | C660G andC630G aresame, C810G islarger thanC630G. |
| Viewing angle(H, V) | Horizontal178°, Vertical178° | Horizontal178°, Vertical 178° | Horizontal178°, Vertical178° | Same |
| Resolution | 3280x2048 | 3280x2048 | 3840x2160 | C660G andC630G aresame, C810G isbetter thanC630G. |
| 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 andC630G aresame, C810G islarger thanC630G. |
| Contrast Ratio | 1000:1 | 2000:1 | 1300:1 | C660G andC810G are largerthan C630G. |
| DICOMcalibratedluminance | 500cd/m² | 800 cd/m² | 1000cd/m² | C660G andC810G are largerthan C630G. |
| Pixel Pitch | 0.197mm×0.197mm | 0.197mm×0.197mm | 0.1816mm×0.1816mm | C660G andC630G aresame, C810G isbetter thanC630G. |
| Backlight | LED | LED | LED | Same. |
| Attributes | Predicate Device | Proposed Device | Discussion of Differences | |
| Product | C630G LCDMonitor | C660G LCDMonitor | C810G LCDMonitor | |
| 510(k) Number | K222121 | K230728 | ||
| DICOM LUT | 16-bit:65536 | 16-bit:65536 | 14-bit:16384 | This parameter is an outputrange.C810G is smaller thanthem, But the three productscan only output 10bit images. |
| Luminancecalibration | Built incalibrationsensor provided | Built in calibrationsensor provided | Built incalibrationsensor provided | Same. |
| Video Signal Input | ||||
| Input signals | DisplayPort 1.2aDVI | DisplayPort 1.2aType-CDVI | DisplayPort 1.2aDVI | The differenceonly shows thatthey havedifferentinput,has nothingto do with thedisplay function. |
| Inputterminational | DisplayPort×2DVI×1 | DisplayPort×2Type-CDVI×1 | DisplayPort×2DVI×1 | The differenceonly shows thatthey havedifferentinput,has nothingto do with thedisplay function. |
| Output signals | DisplayPort 1.2a | DisplayPort 1.2a | NA | C660G andC630G aresame, C810Ghas no outputinterface. |
| OutputTerminational | DisplayPort×1 | DisplayPort×1 | NA | C660G andC630G aresame, C810Ghas no outputinterface. |
| Displaycontroller | 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× 86.8mmWith stand:701.3 mm× 589 mm× 245mm | Without stand:721.5 mm× 493.5 mm× 110mmWith stand:721.5 mm× 585 mm× 262mm | Without stand:756.7 mm× 464.2 mm× 70.2mmWith 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 LCDMonitor | C660G LCDMonitor | C810G LCDMonitor | |
| 510(k) Number | K222121 | K230728 | ||
| Indication for use | JUSHA-C630G/JUSHA-C630/C630G/C630 LCD Monitoris intended to beused indisplaying andviewing digitalimages fordiagnosis of X-ray or MRI, etc.by trainedmedicalpractitioners. Thedevice does notsupport thedisplay ofmammographyimages fordiagnosis. | C660G/C810G LCD Monitor is intendedto be used in displaying and viewingdigital images for diagnosis of X-ray orMRI, etc. by trained medicalpractitioners. The device does notsupport the display of mammographyimages for diagnosis. | Same |
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| Applicablestandard | |||
|---|---|---|---|
| 1 IEC 60601-1:2012, EN60601-1:2013,ANSI/AAMIES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSAC22.2NO.60601-1:14,Medicalequipmentmedical electricalequipment - Part1: Generalrequirements forbasic safety andessentialperformance. | 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 electricalequipment - Part 1: Generalrequirements for basic safety andessential performance. | Same | |
| 2 IEC 60601-1-2Edition 4:2014,EN 60601-1-2:2015, CFR 47FCC Part15subpart B: 2017,Medicalelectricalequipment - Part1-2: Generalrequirements forbasic safety andessentialperformance -Collateralstandard:Electromagneticdisturbances -Requirementsand tests | 2 IEC 60601-1-2 Edition 4:2014, EN60601-1-2:2015, Medical electricalequipment - Part 1-2: Generalrequirements for basic safety andessential performance - Collateralstandard: Electromagnetic disturbances -Requirements and tests |
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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.
§ 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).