What is the regulatory pathway for JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor

Q: Who is the manufacturer of JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor?

Nanjing Jusha Display Technology Co., Ltd. filed the 510(k) submission for JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor (K183492).

Q: What is the FDA product code for JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor?

PGY. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

K183492 · Nanjing Jusha Display Technology Co., Ltd. · PGY · Mar 13, 2019 · Radiology

Device Facts

Record ID	K183492
Device Name	JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor
Applicant	Nanjing Jusha Display Technology Co., Ltd.
Product Code	PGY · Radiology
Decision Date	Mar 13, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2

Intended Use

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.

Device Story

High-resolution (3280x2048) 30-inch color TFT LCD monitor for diagnostic radiology. Inputs digital image signals; processes via internal motherboard and software to optimize display. Features include Color/Gray Automatic (CGA) identification (gray areas use DICOM LUT, color areas use GAMMA2.2 LUT), ambient brightness adaptation, 3D LUT color calibration, real-time DICOM automatic calibration, full-screen brightness equalization, presence induction, focusview, and text mode. Used in clinical settings by medical practitioners to view diagnostic images; output facilitates clinical decision-making by providing calibrated, high-fidelity visualization of radiological data.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including compliance with IEC 60601-1 and IEC 60601-1-2 standards, and internal quality assurance measures (risk analysis, design reviews, integration/system/validation testing).

Technological Characteristics

30-inch color TFT LCD panel; 3280x2048 resolution; 500 cd/m² luminance; 281.47 trillion colors. Features built-in DICOM LUT, 3D LUT, and ambient light sensors. Standards: IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1, CAN/CSA C22.2 NO.60601-1, IEC 60601-1-2 Edition 4:2014, FCC Part 15 Subpart B. Connectivity via data cable.

Indications for Use

Indicated for trained medical practitioners to display and view digital images for diagnosis of X-ray or MRI. Not indicated for mammography image display.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

JUSHA-C61 (K141679)

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 {2}------------------------------------------------ ## 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) | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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., Ltd Add: 301, 8F Block A, No.1, Nanjing International Service Outsourcing Mansion, Hanzhongmen Street, Nanjing, 210036 China | | Contact Person: | Zilong Liang Certification Manager Nanjing Jusha Display Technology Co., Ltd Tel: +86-25- 83305050 Fax: +86-25- 58783273 | | Device Trade Name: | JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD 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 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. | | | 2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47 FCC Part15 subpart B: 2017, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests. | | Intended Use: | JUSHA-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. | | Technology: | 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. | | Determination of Substantial Equivalence: | Summary of Non-Clinical Tests: The LCD Monitor complies with voluntary standards as following: | | | 1 IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601- 1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance. | | | 2 IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47 FCC Part15 subpart B: 2017, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests. | | | JUSHA-C620G LCD/JUSHA-C620/C620G/C620 LCD Monitor is substantially equivalent to JUSHA-C61. JUSHA-C620G LCD/JUSHA-C620/C620G/C620 LCD Monitor employs the maximum resolution values same as that of JUSHA-C61. Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1. Attachment 1 | | | The following quality assurance measures were applied to the development of the system: | | | Risk Analysis Requirements Reviews Design Reviews Raw materials verification Testing on unit level (Module verification) Integration testing (System verification) Final acceptance testing (Validation) Performance testing (Verification) Safety testing (Verification) | | | Summary of Clinical Tests: The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence. The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the subject device is determined as safe and effectiveness. | | Conclusion: | Nanjing Jusha Display Technology Co., Ltd Considers the JUSHA- C620G LCD Monitor to be as safe, as effective, and performance is substantially equivalent to the predicate device(s). | {4}------------------------------------------------ {5}------------------------------------------------