(50 days)
JUSHA-C23C; K151861
Not Found
No
The description focuses on display technology features like resolution, luminance, and DICOM calibration, with no mention of AI or ML algorithms for image analysis or processing. The "ambient brightness adapting, real-time DICOM automatic calibration and presence induction system" are described as automatic adjustments based on environmental factors and presence, not as learning or predictive systems.
No.
The device is an LCD monitor used for displaying digital images for diagnosis, not for providing therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc."
No
The device description explicitly lists hardware components such as an LCD Panel, main board, power adapter, and data cable, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The JUSHA-C270G/JUSHA-C270/C270G/C270 LCD Monitor is a display system used for viewing digital images from modalities like X-ray and MRI. It does not perform any tests on biological samples.
- Intended Use: The intended use is to display and view digital images for diagnosis, which is a function of medical imaging equipment, not IVD.
Therefore, this device falls under the category of medical imaging display devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
JUSHA-C270G/JUSHA-C270/C270G/C270 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-C270G/JUSHA-C270/C270G/C270 LCD Monitor is the display system with the high resolution (1600*1200), high luminance (600 cd/m²), and 281.47 trillion colors, built-in DICOM standard LUT. In particular, JUSHA-C270G has ambient brightness adapting, real-time DICOM automatic calibration and presence induction system, 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:
- 21.3" Color TFT LCD Panel
- DMX0302CR0/main board/V1.2
- JUSHA-C270G 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:
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray or MRI
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
Bench testing: Bench testing was conducted to demonstrate the JUSHA-C270G 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 JUSHA-C270G 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, JUSHA-C270G, does not require animal or clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
JUSHA-C23C; K151861
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 logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are displayed side-by-side.
Nanjing Jusha Display Technology Co., Ltd. % Zilong Liang Certification Manager Suite A. 8/F. Bldg 1. No. 301. Hanzhongmen St. Naniing, Jiangsu 210036 CHINA
February 5, 2019
Re: K183498
Trade/Device Name: JUSHA-C270G/ JUSHA-C270/C270G/C270 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
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 medical devices and radiation-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,
Jeff Bages
for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K183498
Device Name
JUSHA-C270G/JUSHA=C270/C270G/C270 LCD Monitor
Indications for Use (Describe)
JUSHA-C270G/JUSHA-C270/C270G/C270 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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3
K183498
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | December 5, 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-C270G/JUSHA-C270/C270G/C270 LCD Monitor |
| Common/Usual Name: | 2MP Color LCD Monitor |
| Classification Name: | Display, Diagnostic Radiology 21CFR 892.2050 |
| Product Code: | PGY |
| Predicate Device(s): | JUSHA-C23C; K151861 |
| Device Description: | JUSHA-C270G/JUSHA-C270/C270G/C270 LCD Monitor is the |
| display system with the high resolution (1600*1200), high luminance | |
| (600 cd/m²), and 281.47 trillion colors, built-in DICOM standard | |
| LUT. In particular, JUSHA-C270G has ambient brightness adapting, | |
| real-time DICOM automatic calibration and presence induction | |
| system, 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: |
- 21.3" Color TFT LCD Panel
- DMX0302CR0/main board/V1.2
- JUSHA-C270G 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: |
| Intended Use: | JUSHA-C270G/JUSHA-C270/C270G/C270 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-C270G/JUSHA-C270/C270G/C270 LCD Monitor is the
display system with the high resolution (1600*1200), high luminance
(600 cd/m2), and 281.47 trillion colors, built-in DICOM standard
LUT. In particular, JUSHA-C270G has ambient brightness adapting,
real-time DICOM automatic calibration and presence induction
system, 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-C270G/JUSHA-C270/C270G/C270 LCD Monitor is
substantially equivalent to JUSHA-C23C.
JUSHA-C270G/JUSHA-C270/C270G/C270 LCD Monitor employs
the maximum resolution values same as that of JUSHA-C23C.
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-C270G LCD Monitor to be as safe, as effective, and
performance is substantially equivalent to the predicate device(s). |
4
5
12.1 Product Comparison
This comparison identifies the similarities and differences of the proposed JUSHA-C270G LCD Monitor device to the legally marketed predicate JUSHA-C33C LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | JUSHA-C23C | JUSHA-C270G/JUSHA-C27
0/C270G/C270 LCD
Monitor | |
| 510(k) Number | K151861 | / | |
| Display Performance/Specifications | | | |
| Screen
technology | 21.3" Color TFT LCD Panel | 21.3" Color TFT LCD Panel | Same |
| Viewing angle
(H, V) | Horizontal 176°, Vertical
176° | Horizontal 178°, Vertical
178° | - |
| Resolution | 1600 x 1200/1200 x 1600 | 1600 x 1200/1200 x 1600 | Same |
| Display area | 432.0 (H) x 324.0(V) mm | 432.0 (H) x 324.0(V) mm | Same |
| Contrast Ratio | 1400:1 | 1400:1 | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | JUSHA-C23C | JUSHA-C270G/JUSHA-C27
0/C270G/C270 LCD
Monitor | |
| 510(k) Number | K151861 | / | |
| Scanning
frequency (H; V) | 5276 kHz;5961Hz | 37.975kHz;60Hz | This difference240V 50~60Hz | DC 24V | - |
between the two
device is caused
by the different
no display area
defined by
different
manufacturers ,
nothing to do
with the display
function |
| Recommended
Luminance | 400cd/m² | 350cd/m² | This difference
between the two
devices is caused
by factory
setting, nothing
to do with the
display function |
| Pixel Pitch | 0.27x0.27 mm | 0.27x0.27 mm | Same |
| Backlight | LED | LED | Same. |
| Display Colors | 12-bit | 16-bit | The
JUSHA-C270G
LCD Monitor
uses a color bit
expansion
technology to
improve image
display quality,
the image clarity
is better than the
image displayed
on the predicate
device. |
| Luminance
calibration | Built in calibration sensor
provided | Built in calibration sensor
provided | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | JUSHA-C23C | JUSHA-C270G/JUSHA-C27
0/C270G/C270 LCD
Monitor | |
| 510(k) Number | K151861 | / | |
| Input signals | DVI-D x 1,
DisplayPort x 1 | DVI-D x 1,
DisplayPort x 1 | same |
| Display
controller | Off the shelf | Off the shelf | Same |
| Power Related Specification | | | |
| Power
Requirement | AC 100
| Power
Consumption/Sa
ve Mode | 65W/less than 2.5W | 50W/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 | DVI DMPM | DVI DMPM | Same |
| Management | DisplayPort 1.1a | DisplayPort 1.1a | |
| Miscellaneous Features/Specifications | | | |
| USB | 1 upstream (endpoint), | 1 upstream (endpoint), | Same |
| Ports/standard | 2 downstream/ Rev. 2.0 | 2 downstream/ Rev. 2.0 | |
| Dimensions w/o | Without stand:
382mm x490mm x75mm | Without stand:
382mm x490mm x77mm | Different |
| stand | With stand:
382mm x533mm x238mm | With stand:
382mm x635mm x238mm | housing design |
| (W x H x D) | | | due to the
different panel
size. |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | JUSHA-C23C | JUSHA-C270G/JUSHA-C27
0/C270G/C270 LCD
Monitor | |
| 510(k) Number | K151861 | / | |
| Indication for
use | JUSHA-C23C 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-C270G 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 |
| Applicable
standard | 1 IEC 60601-1Medical
equipment medical electrical
equipment - Part 1: General
requirements for basic safety
and essential performance
2005+CORR.1(2006)+COR
R.2(2007)
2 IEC 60601-1-2 Edition
3:2007, Medical electrical
equipment - Part 1-2:
General requirements for
basic safety and essential
performance - Collateral
standard: Electromagnetic
compatibility - Requirements
and tests. | 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. | - |
6
7
8
9
PERFORMANCE DATA:
The following performance data were provided in support of the substantial equivalence determination.
Bench testing:
Bench testing was conducted to demonstrate the JUSHA-C270G 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 JUSHA-C270G 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, JUSHA-C270G, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
JUSHA-C270G/JUSHA-C270/C270G/C270 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 JUSHA-C270G Medical Display does not raise any new issues of safety or effectiveness.