(29 days)
Not Found
No
The device description focuses on display technology and calibration, with no mention of AI/ML algorithms for image analysis or processing.
No
The device is a monitor used for displaying medical images for diagnosis, not for treating a condition.
Yes
The device is intended to be used in 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 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-M260G/JUSHA-M260/M260G/M260 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.
The device is a medical device, specifically a medical display monitor, but it falls under the category of medical imaging devices rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
JUSHA-M260G/JUSHA-M260/M260 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 (comma separated list FDA assigned to the subject device)
PGY
Device Description
JUSHA-M260G/JUSHA-M260/M260 LCD Monitor is the display system with the high resolution (1600*1200), high luminance (800 cd/m²), and 14-bit grayscale (16384 level), built-in DICOM standard LUT. In particular, JUSHA-M260G has real-time DICOM automatic calibration 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" Mono-TFT LCD Panel
- DMX0302CR0/main board/V1.2
- JUSHA-M260G LCD Monitor software
- Power Adapter
- Data Cable.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted to demonstrate the JUSHA-M260G 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 EMC testing were conducted on the JUSHA-M260G. The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
The subject of this premarket submission, JUSHA-M260G, does not require animal or clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
JUSHA-M23C; K151238
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K183497
Device Name
JUSHA-M260G/JUSHA-M260/M260G/M260 LCD Monitor
Indications for Use (Describe)
JUSHA-M260G/JUSHA-M260/M260 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
"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."
==============================================================================================================================================================================
1
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-M260G/JUSHA-M260/M260G/M260 LCD Monitor | |
| Common/Usual Name: | 2MP monochrome LCD Monitor | |
| Classification Name: | Display, Diagnostic Radiology 21CFR 892.2050 | |
| Product Code: | PGY | |
| Predicate Device(s): | JUSHA-M23C; K151238 | |
| Device Description: | JUSHA-M260G/JUSHA-M260/M260G/M260 LCD Monitor is the | |
| display system with the high resolution (1600*1200), high luminance | ||
| (800 cd/m²), and 14-bit grayscale (16384 level), built-in DICOM | ||
| standard LUT. In particular, JUSHA-M260G has real-time DICOM | ||
| automatic calibration 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" Mono-TFT LCD Panel
- DMX0302CR0/main board/V1.2
- JUSHA-M260G LCD Monitor software
- Power Adapter
- Data Cable. | |
| | 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.
- 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-M260G 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-M260G LCD Monitor is the display system with the high
resolution (1600*1200), high luminance (800 cd/m2), and 14-bit
grayscale (16384 level), built-in DICOM standard LUT. In particular,
JUSHA-M260G has real-time DICOM automatic calibration 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-M260G is substantially equivalent to JUSHA-M23C.
JUSHA-M260G employs the maximum resolution values same as that
of JUSHA-M23C. 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-M260G LCD Monitor to be as safe, as effective, and performance is substantially equivalent to the predicate device(s). | |
2
3
4
This comparison identifies the similarities and differences of the proposed JUSHA-M260G LCD Monitor device to the legally marketed predicate JUSHA-M23C LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | JUSHA-M23C | JUSHA-M260G | |
| 510(k) Number | K151238 | / | |
| Display Performance/Specifications | | | |
| Screen
technology | 21.3" Mono-TFT LCD Panel | 21.3" Mono-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 |
| Scanning
frequency (H; V) | 5276 kHz;5961Hz | 37.975kHz;60Hz | This difference240V 50~60Hz | DC 12V | - |
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 | 500cd/m² | 400cd/m² | This difference
between the two
device is caused
by the different
no display area
defined by
different
manufacturers ,
nothing to do
with the display
function |
| Pixel Pitch | 0.27x0.27 mm | 0.27x0.27 mm | Same |
| Backlight | LED | LED | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | JUSHA-M23C | JUSHA-M260G | |
| 510(k) Number | K151238 | / | |
| DICOM LUT | 12-bit:4096 | 14-bit:16384 | The
JUSHA-M260G
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 |
| | | Video Signal Input | |
| Input signals | DVI-D x 1, | DVI-D x 1, | Same |
| | DisplayPort x 1 | DisplayPort x 1 | |
| Display
controller | Off the shelf | Off the shelf | Same |
| | | Power Related Specification | |
| Power
Requirement | AC 100
| Power
Consumption/Save Mode | 45W/less than 3W | 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 |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | JUSHA-M23C | JUSHA-M260G | |
| 510(k) Number | K151238 | / | |
| Power
Management | DVI DMPM
DisplayPort 1.1a | DVI DMPM
DisplayPort 1.1a | Same |
| Miscellaneous Features/Specifications | | | |
| USB
Ports/standard | 1 upstream (endpoint),
2 downstream/ Rev. 2.0 | 1 upstream (endpoint),
2 downstream/ Rev. 2.0 | Same |
| Dimensions w/o
stand
(W x H x D) | Without stand:
382mm x490mm x75mm
With stand:
382mm x533mm x238mm | Without stand:
382mm x490mm x77mm
With stand:
382mm x635mm x238mm | Different
housing design
due to the
different panel
size. |
| Indication for
use | JUSHA-M23C 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-M260G 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 |
5
6
7
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|------------------------|-------------------------------|-------------------------------|------------------------------|
| Product | JUSHA-M23C | JUSHA-M260G | - |
| 510(k) Number | K151238 | / | - |
| Applicable
standard | 1 IEC 60601-1Medical | 1 IEC 60601-1:2012, EN | |
| | equipment medical electrical | 60601-1:2013, ANSI/AAMI | |
| | equipment - Part 1: General | ES60601-1:2005+A1:2012+ | |
| | requirements for basic safety | C1:2009+A2:2010, | |
| | and essential performance | CAN/CSA C22.2 | |
| | 2005+CORR.1(2006)+COR | NO.60601-1:14, Medical | |
| | R.2(2007) | equipment medical electrical | |
| | | equipment - Part 1: General | |
| | 2 IEC 60601-1-2 Edition | requirements for basic safety | |
| | 3:2007, Medical electrical | and essential performance. | |
| | equipment - Part 1-2: | | |
| | General requirements for | 2 IEC 60601-1-2 Edition | |
| | basic safety and essential | 4:2014, EN 60601-1-2:2015, | |
| | performance - Collateral | CFR 47 FCC Part15 subpart | |
| | standard: Electromagnetic | B: 2017, Medical electrical | |
| | compatibility - Requirements | equipment - Part 1-2: | |
| | and tests. | General requirements for | |
| | | basic safety and essential | |
| | | performance - Collateral | |
| | | standard: Electromagnetic | |
| | disturbances - Requirements | | |
| | and tests. | | |
8
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-M260G 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-M260G 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-M260G, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
JUSHA-M260G 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. Nanjing Jusha Display Technology Co., Ltd considers the JUSHA-M260G Medical Display does not raise any new issues of safety or effectiveness.
9
Image /page/9/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 15, 2019
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: K183497
Trade/Device Name: JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: PGY Dated: December 20, 2018 Received: December 20, 2018
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.
10
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,
Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure