(86 days)
JUSHA-C620G LCD/JUSHA-C620/C620G/C620 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.
JUSHA-C620G LCD/JUSHA-C620/C620G/C620 LCD Monitor is the display system with the high resolution (3280*2048), high luminance (500 cd/m²), and 281.47 trillion colors, built-in DICOM standard LUT. In particular, JUSHA-C620G LCD Monitor contains CGA function, it is specially made by JUSHA, it can automatic identify gray and color signals, then gray area calls DICOM LUT and color area calls GAMMA2.2 LUT. In addition, JUSHA-C620G has ambient brightness adapting, 3D LUT color calibration, real-time DICOM automatic calibration, Full-screen brightness equalization, presence induction, focusview and text mode function, 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:
- 30" Color TFT LCD Panel
- C44&C62 Mother board/FR-6/V1.2
- JUSHA-C620G 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.
The provided text is a 510(k) summary for the JUSHA-C620G LCD Monitor. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. For such devices, the focus is on non-clinical testing and comparison to a predicate, rather than extensive clinical studies or AI algorithm performance.
Therefore, the requested information regarding acceptance criteria, study design for AI models, human expert involvement, and ground truth establishment (which are typical for AI/ML medical devices) is not applicable to this specific submission. This device is a medical display monitor, not an AI diagnostic algorithm.
Specifically, the document states:
- "Summary of Clinical Tests: The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence." (Page 4, under "Determination of Substantial Equivalence")
This indicates that the manufacturer did not conduct a clinical study to prove the device's performance against specific acceptance criteria in a real-world clinical setting, as would be expected for an AI software. Instead, substantial equivalence was demonstrated through non-clinical tests (meeting safety and performance standards like IEC 60601-1 and IEC 60601-1-2) and a comparison table of characteristics with the predicate device (JUSHA-C61; K141679).
Therefore, I cannot provide the requested details because they are not part of the information required or presented in this 510(k) submission for a medical display monitor.
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Nanjing Jusha Display Technology Co., Ltd. % Zilong Liang Certification Manager Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St., Nanjing, Jiangsu 210036 CHINA
Re: K183492
Trade/Device Name: JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: January 11, 2019 Received: January 11, 2019
Dear Zilong Liang:
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
March 13, 2019
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183492
Device Name
JUSHA-C620G LCD Monitor, JUSHA-C620 LDC Monitor, C620G LCD Monitor, C620 LCD Monitor
Indications for Use (Describe)
JUSHA-C620G LCD/JUSHA-C620/C620G/C620 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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K183492
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | December 6, 2018 |
|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., LtdAdd: 301, 8F Block A, No.1, Nanjing International ServiceOutsourcing Mansion, Hanzhongmen Street, Nanjing, 210036 China |
| Contact Person: | Zilong LiangCertification ManagerNanjing Jusha Display Technology Co., LtdTel: +86-25- 83305050Fax: +86-25- 58783273 |
| Device Trade Name: | JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620GLCD Monitor, C620 LCD Monitor |
| Common/Usual Name: | 6MP Color LCD Monitor |
| Classification Name: | Display, Diagnostic Radiology 21CFR 892.2050 |
| Product Code: | PGY |
| Predicate Device(s): | JUSHA-C61; K141679 |
| Device Description: | JUSHA-C620G LCD/JUSHA-C620/C620G/C620 LCD Monitor isthe display system with the high resolution (3280*2048), highluminance (500 cd/m²), and 281.47 trillion colors, built-in DICOMstandard LUT. In particular, JUSHA-C620G LCD Monitor containsCGA function, it is specially made by JUSHA, it can automaticidentify gray and color signals, then gray area calls DICOM LUT andcolor area calls GAMMA2.2 LUT. In addition, JUSHA-C620G hasambient brightness adapting, 3D LUT color calibration, real-timeDICOM automatic calibration, Full-screen brightness equalization,presence induction, focusview and text mode function, with these thisdisplay can automatic adjustment according to different requirementsin order to achieve the best results.The product is consisted of the following components:- 30" Color TFT LCD Panel- C44&C62 Mother board/FR-6/V1.2- JUSHA-C620G LCD Monitor software- Power Adapter- Data Cable.The LCD Monitor is designed, tested, and will be manufactured inaccordance 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 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,CFR 47 FCC Part15 subpart B: 2017, Medical electricalequipment - Part 1-2: General requirements for basicsafety and essential performance - Collateral standard:Electromagnetic disturbances - Requirements and tests. | |
| Intended Use: | JUSHA-C620G LCD/JUSHA-C620/C620G/C620 LCD Monitor isintended to be used in displaying and viewing digital images fordiagnosis of X-ray or MRI, etc. by trained medical practitioners. Thedevice does not support the display of mammography images fordiagnosis. |
| Technology: | JUSHA-C620G LCD/JUSHA-C620/C620G/C620 LCD Monitor isthe display system with the high resolution (3280*2048), highluminance (500 cd/m2), and 281.47 trillion colors, built-in DICOMstandard LUT. In particular, JUSHA-C620G LCD Monitor containsCGA function, it is specially made by JUSHA, it can automaticidentify gray and color signals, then gray area calls DICOM LUT andcolor area calls GAMMA2.2 LUT. In addition, JUSHA-C620G hasambient brightness adapting, 3D LUT color calibration, real-timeDICOM automatic calibration, Full-screen brightness equalization,presence induction, focusview and text mode function, with these thisdisplay can automatic adjustment according to different requirementsin order to achieve the best results. |
| Determination of SubstantialEquivalence: | 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 C22.2NO.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, CFR 47FCC Part15 subpart B: 2017, Medical electrical equipment - Part1-2: General requirements for basic safety and essentialperformance - Collateral standard: Electromagnetic disturbances -Requirements and tests. | |
| JUSHA-C620G LCD/JUSHA-C620/C620G/C620 LCD Monitor issubstantially equivalent to JUSHA-C61. JUSHA-C620GLCD/JUSHA-C620/C620G/C620 LCD Monitor employs themaximum resolution values same as that of JUSHA-C61. Comparisontable of the principal characteristics of 2 devices is shown in theAttachment 1.Attachment 1 | |
| 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 the JUSHA-C620G LCD Monitor to be as safe, as effective, and performance issubstantially equivalent to the predicate device(s). |
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§ 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).