(54 days)
CP620G/CP620 LCD Monitor is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
CP620G/CP620 LCD Monitor is the display system with the high resolution (30002000), high luminance (500 cd/m2), and 4398 billion colors, built-in DICOM standard LUT. Monitor is portable and light, the 750g weight make it is easy to carry. With these this display can automatic adjustment according to different requirements in order to achieve the best results.(There is no difference between CP620G and CP620 except for labeling as they are marketed in different areas. CP620G is global sales, CP620 is domestic sales .It does not affect their safety or effectiveness in any terms. ) The product is consisted of the following components: - 13.5" Color-TFT LCD Panel - DMS3400AR0/6 layers/214150mm/1.0mm/REV:1.0 - CP620G LCD Monitor software - Power Adapter - Data Cable. In accordance with the May 11, 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software level of concern for the CP620G/CP620 LCD Monitor was determined to be Moderate on account of a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. the software doesn't include any functions of image manipulation. 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.
The information provided describes the Nanjing Jusha Display Technology Co., Ltd. CP620G LCD Monitor / CP620 LCD Monitor. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" in the traditional sense of measurable thresholds for diagnostic accuracy (e.g., sensitivity, specificity for an AI algorithm). Instead, the performance data presented focuses on the technical specifications of the display and compliance with established electrical safety and electromagnetic compatibility (EMC) standards. The "predicate device" is used as the benchmark for substantial equivalence.
| Attribute | Acceptance Criteria (Predicate Device K200472) | Reported Device Performance (CP620G / CP620 LCD Monitor - K230643) |
|---|---|---|
| Screen Technology | 13.5" Color TFT LCD Panel | 13.5" Color TFT LCD Panel |
| Viewing Angle (H, V) | Horizontal 170°, Vertical 170° | Horizontal 170°, Vertical 170° |
| Resolution | 3000x2000 | 3000x2000 |
| Display Area | 285.3(V)x190.2(H)mm | 285.3(V)x190.2(H)mm |
| Contrast Ratio | 1800:1 | 1800:1 |
| Scanning frequency (H; V) | 94.94~123.84kHz; 60Hz | 94.94~123.84kHz; 60Hz |
| Recommended Luminance | 300cd/m2 | 500cd/m2 |
| Pixel Pitch | 0.0951x0.0951mm | 0.0951x0.0951mm |
| Backlight | LED | LED |
| Display Colors | 14-bit, 4398 billion colors | 14-bit, 4398 billion colors |
| Luminance Calibration | General calibration sensor | General calibration sensor |
| Video Signal Input | Type-C x1, Mini DP x1 | Type-C x2, HDMI x1 |
| Display Controller | Off the shelf | Off the shelf |
| Power Requirement | AC 100 | AC 100 |
| Power Consumption/Save Mode | 15W / N/A | 20W / NA |
| Applicable 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; IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015 | 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; IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015 |
Discussion of Differences:
- Recommended Luminance: The proposed device has a higher recommended luminance (500cd/m2) than the predicate (300cd/m2), which is considered an improvement ("CP620G is better than CP610").
- Video Signal Input: The proposed device has different input ports (Type-C x2, HDMI x1 vs. Type-C x1, Mini DP x1). This difference is stated to "only shows that they have different input, has nothing to do with the display function."
- Power Consumption/Save Mode: The proposed device has a higher power consumption (20W vs. 15W). This is attributed to "components used in the LCD Monitor" and is stated to have "nothing to do with the display function."
- Dimensions w/o stand: Slight differences are noted (312.3mmx220mmx11.5mm vs. 323mmx225x11.5mm), explained as "Different housing design due to the different glass size."
- New Features: The proposed device includes new features: Bidirectional power supply function, dual-screen display function, gravity sensing function, adaptive environment brightness function, and screen touch function. These are all described as making the product "more convenient" and "has nothing to do with the display function" (except for dual-screen display, which allows two independent 3MP windows side-by-side).
2. Sample size used for the test set and the data provenance
The document describes bench testing for the CP620/CP620G. There is no mention of a "test set" in the context of clinical images or patient data. The testing pertains to the physical and electrical performance of the display monitor itself. Therefore, concepts like sample size and data provenance (country, retrospective/prospective) are not applicable in the way they would be for an AI diagnostic algorithm. The tests conducted include:
- 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
- Measurement of the chromaticity non-uniformity characteristics of the display screen
- Measurement of small-spot contrast ratio
- Measurement of temporal response
- Performance data on luminance stability
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is an LCD monitor for displaying medical images, not an AI algorithm that provides diagnostic interpretations requiring expert ground truth setting for a dataset. The "ground truth" for this device relates to its physical performance characteristics meeting technical specifications, which are verified through various physical and electrical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated above.
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
No MRMC comparative effectiveness study was done. This device is an LCD monitor, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance acceptance is based on:
- Technical Specifications: Measured physical and electrical properties of the display (luminance, contrast, resolution, viewing angle, color, etc.) matching or exceeding the predicate device's specifications.
- Compliance with Standards: Adherence to recognized medical device safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) standards.
8. The sample size for the training set
This information is not applicable. The device is a monitor, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
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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 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
May 1, 2023
Re: K230643
Trade/Device Name: CP620G LCD monitor, CP620 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 9, 2023 Received: March 9, 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 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
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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, Ph.D. 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) K230643
Device Name CP620G LCD Monitor / CP620 LCD Monitor
Indications for Use (Describe)
CP620G/CP620 LCD Monitor is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Type of Use (Select one or both, as applicable)
| Research Use (Part 1, CFR 301 Subpart D) |
|---|
| Commodity Use (Part 1, CFR 319) |
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
(K230643)
1.In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | Mar 3, 2023 |
|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., LtdAdd: 8A, Block 1. Nanjing International Service Outsourcing Mansion,No. 301, Hanzhongmen street, Nanjing City, Jiangsu Province, 210036China. |
| Contact Person: | Donny LeeCertification EngineerNanjing Jusha Display Technology Co., LtdTel: +86-25- 83305050Fax: +86-25- 58783273 |
| Device TradeName: | CP620G LCD Monitor, CP620 LCD Monitor |
| Common/UsualName: | 6MP Color LCD Monitor |
| ClassificationName: | Medical Image Management and Processing System, 21 CFR 892.2050 |
| Product Code: | PGY |
| Device Class | Class II |
| PredicateDevice(s): | JUSHA-CP610; K200742 |
| ClassificationName: | Medical Image Management and Processing System ,21 CFR 892.2050 |
| Product Code: | PGY |
| Device Class | Class II |
| DeviceDescription: | CP620G/CP620 LCD Monitor is the display system with the highresolution (3000*2000), high luminance (500 cd/m2), and 4398 billion |
| Monitor is portable and light, the 750g weight make it is easy to carry.With these this display can automatic adjustment according to differentrequirements in order to achieve the best results.(There is no differencebetween CP620G and CP620 except for labeling as they are marketedin different areas. CP620G is global sales, CP620 is domestic sales .Itdoes not affect their safety or effectiveness in any terms. )The product is consisted of the following components:- 13.5" Color-TFT LCD Panel- DMS3400AR0/6 layers/214*150mm/1.0mm/REV:1.0- CP620G LCD Monitor software- Power Adapter- Data Cable.In accordance with the May 11, 2005 Guidance for the Content ofPremarket Submissions for Software Contained in Medical Devices, thesoftware level of concern for the CP620G/CP620 LCD Monitor wasdetermined to be Moderate on account of a failure or latent flaw couldindirectly result in minor injury to the patient or operator through incorrector delayed information or through the action of a care provider. thesoftware doesn't include any functions of image manipulation.The LCD Monitor is designed, tested, and will be manufactured inaccordance 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/CSAC22.2 NO.60601-1:14, Medical equipment medical electricalequipment - Part 1: General requirements for basic safety andessential performance.2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, Medicalelectrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral standard:Electromagnetic disturbances - Requirements and tests. | |
| Intended Use: | CP620G/CP620 LCD Monitor is intended to be used in displaying andviewing digital images for review and analysis by trained medicalpractitioners. It does not support the display of mammography images fordiagnosis. |
| Technology: | CP620G/CP620 LCD Monitor is the display system with the highresolution (3000*2000), high luminance (500 cd/m²), and 4.398 billion |
| colors, built-in DICOM standard LUT. In particular, CP620G/CP620 LCDMonitor is portable and light, the 750 g weight make it is easy to carry.With these this display can automatic adjustment according to differentrequirements in order to achieve the best results. | |
| Determination ofSubstantialEquivalence: | Summary of Non-Clinical Tests:The LCD Monitor complies with voluntary standards as following:1 IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMIES60601-1:2005+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 basic safetyand essential performance - Collateral standard: Electromagneticdisturbances - Requirements and testsCP620G LCD Monitor are substantially equivalent to JUSHA-CP610LCD Monitor. They have equivalent characteristics and functionsaccording to comparison table, please refer to 2. Product ComparisonThe 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 not requireclinical studies to support substantial equivalence.The proposed device is Substantially Equivalent (SE) to the predicatedevice which is US legally market device. Therefore, the subject device isdetermined as safe and effectiveness. |
| Conclusion: | Nanjing Jusha Display Technology Co., Ltd Considers theCP620G/CP620 LCD Monitor to be as safe as effective and performance |
| is substantially equivalent to the predicate device(s). |
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2. Product Comparison
This comparison identifies the similarities and differences of the proposed CP620G LCD Monitor device to the legally marketed predicate JUSHA-CP610 LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
|---|---|---|---|
| Product | JUSHA-CP610 | CP620G LCD Monitor | |
| 510(k) Number | K200472 | K230643 | |
| Display Performance/Specifications | |||
| Screentechnology | 13.5" Color TFT LCD Panel | 13.5" Color TFT LCD Panel | Same |
| Viewingangle(H, V) | Horizontal 170°,Vertical170° | Horizontal 170°,Vertical170° | Same |
| Resolution | 3000×2000 | 3000×2000 | Same |
| Display area | 285.3(V)×190.2(H)mm | 285.3(V)×190.2(H)mm | Same |
| Contrast Ratio | 1800:1 | 1800:1 | Same |
| Scanningfrequency (H; V) | 94.94~123.84kHz; 60Hz | 94.94~123.84kHz; 60Hz | Same |
| RecommendedLuminance | 300cd/m2 | 500cd/m2 | CP620G is betterthan CP610 |
| Pixel Pitch | 0.0951×0.0951mm | 0.0951×0.0951mm | Same. |
| Backlight | LED | LED | Same. |
| Display Colors | 14-bit, 4398 billion colors | 14-bit, 4398 billion colors | Same. |
| Luminancecalibration | General calibration sensor | General calibration sensor | Same |
| Video Signal Input | |||
| Input signals | Type-C×1,Mini DP×1 | Type-C×2HDMI×1 | The differenceonly shows thatthey havedifferent input,has nothing to dowith the displayfunction. |
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| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences | ||
|---|---|---|---|---|---|
| Product | JUSHA-CP610 | CP620G LCD Monitor | |||
| 510(k) Number | K200472 | K230643 | |||
| Output signals | - | - | |||
| Displaycontroller | Off the shelf | Off the shelf | Same | ||
| Power Related Specification | |||||
| PowerRequirement | AC 100 | AC 100 | Same | ||
| PowerConsumption/Save Mode | 15W / N/A | 20W/NA | 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 | ||
| PowerManagement | NA | NA | Same | ||
| Miscellaneous Features/Specifications | |||||
| USBPorts/standard | upstream (endpoint)/Rev.3.1 | upstream (endpoint)/Rev.3.1 | |||
| Dimensions w/ostand(W×H×D) | 323mm×225×11.5mm | 312.3mm×220mm×11.5mm | Different housing design due to the different glass size. | ||
| Indication foruse | JUSHA-CP610 LCDMonitor is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography | CP620G/CP620 LCDMonitor is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography | CP620G/CP620 LCD Monitor is the display system with the high resolution (3000*2000), high luminance (500 cd/m2), and |
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| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
|---|---|---|---|
| Product | JUSHA-CP610 | CP620G LCD Monitor | |
| 510(k) Number | K200472 | K230643 | |
| Applicablestandard | 1 IEC 60601-1:2012, EN60601-1:2013, ANSI/AAMIES60601-1:2005+A1:2012+C1:2009+A2:2010,CAN/CSA C22.2NO.60601-1:14, Medicalequipment medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance.2 IEC 60601-1-2 Edition4:2014, EN 60601-1-2:2015,Medical electrical equipment- Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral standard:Electromagnetic disturbances- Requirements and tests | 1 IEC 60601-1:2012, EN60601-1:2013, ANSI/AAMIES60601-1:2005+A1:2012+C1:2009+A2:2010,CAN/CSA C22.2NO.60601-1:14, Medicalequipment medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance.2 IEC 60601-1-2 Edition4:2014, EN 60601-1-2:2015,Medical electrical equipment- Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral standard:Electromagnetic disturbances- Requirements and tests | colors, can beused indisplaying andviewing digitalimages fordiagnosis ofX-ray, MRI andmammography,etc.Same |
| New Features | |||
| Bidirectionalpower supplyfunction | / | When one USB-C isconnected to the powersupply, it can power theCP620 and reverse chargethe connected phone orcomputer through the otherUSB-C port | This is a newfeature ofCP620G thatmakes using theproduct moreconvenient andhas nothing to dowith the display |
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
| Product | JUSHA-CP610 | CP620G LCD Monitor | |
| 510(k) Number | K200472 | K230643 | |
| dual-screendisplay function | / | With two inputs connected,users can have a seamlessexperience like a traditional6MP medical monitor, twoindependent 3MP windowside by side. | This is a newfeatureofCP620Gthatmakes using theproductmoreconvenient. |
| gravity sensingfunction | / | With build-in gravity sensor,windowswillrotateautomatically withthedevice orientation. | This is a newfeatureofCP620Gthatmakes using theproductmoreconvenient andhas nothing to dowith the displayfunction. |
| Adaptiveenvironmentbrightnessfunction | / | CP620G will monitor theambient light in real time,and change brightness andDICOMcompensationaccordingly, making it morecomfortable to do diagnosisin differentlightingenvironment | This is a newfeatureofCP620Gthatmakes using theproductmoreconvenient. |
| Screen touchfunction | / | The touch screen enablesusers directly interact withPACS and many moresoftware with fingers. Easierand more intuitive | This is a newfeatureofCP620Gthatmakes using theproductmoreconvenient andhas nothing to dowith the displayfunction. |
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PERFORMANCE DATA:
The following performance data were provided in support of the substantial equivalence
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determination.
Bench testing:
Bench testing was conducted to demonstrate the CP620/CP620G 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 .
- Measurement of the chromaticity non-uniformity characteristics of the display screen.
- 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 CP620G 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, CP620G, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
CP620G 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. Naniing Jusha Display Technology Co., Ltd considers the CP620G 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).