(86 days)
Not Found
No
The device description details display features and automatic adjustments based on signal type and ambient conditions, but does not mention AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is an LCD monitor intended for displaying and viewing digital images for diagnosis, not for providing therapy.
Yes
The stated "Intended Use / Indications for Use" is "displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners."
No
The device description explicitly lists hardware components such as a TFT LCD Panel, Motherboard, Power Adapter, and Data Cable, in addition to software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for "displaying and viewing digital images for diagnosis of X-ray or MRI, etc." This describes a device used for interpreting medical images, which are typically generated from imaging modalities applied directly to the patient.
- Device Description: The description details a medical monitor with features designed for displaying medical images (high resolution, luminance, DICOM support, etc.).
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens.
The device is a medical imaging display, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
PGY
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.
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray or MRI, etc.
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
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.
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.
Key Metrics
Not Found
Predicate Device(s)
JUSHA-C61; K141679
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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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., 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). |
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