(197 days)
No
The document describes a medical display with standard display technology and software for image presentation, without mentioning any AI or ML capabilities.
No
The device is a medical display intended for viewing medical images, not for providing therapy or treatment.
No
This device is a medical display, specifically for displaying images from modalities like digital mammography. While it is used by physicians for viewing medical images, it does not itself perform any diagnostic function or analysis of those images; it simply presents them.
No
The device description explicitly lists hardware components such as a Liquid Crystal Display, Motherboard, Power Adapter, and Data Cable, in addition to software.
Based on the provided information, the JUSHA-MS2C Medical Display is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for displaying medical images, specifically mentioning digital mammography systems. This is a function related to visualizing diagnostic information, not performing a diagnostic test on a biological sample.
- Device Description: The description details a display system with technical specifications related to image quality (resolution, luminance, grayscale). It doesn't mention any components or processes involved in analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Reagents or assays
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Measurement of analytes
- Providing a diagnostic result based on laboratory testing
The device is a medical display, which is a crucial component in the workflow of interpreting medical images for diagnosis, but it is not the device that performs the diagnostic test itself.
N/A
Intended Use / Indications for Use
JUSHA-M52C Medical Display is intended to be used by trained physicians in various kinds of medical image applications including digital mammography system for which the device complies with the performance specified by the manufacturer of the system.
Product codes
LLZ
Device Description
JUSHA-M52C Medical Display is the display system with the high resolution(2048 x 2560), high luminance(700 cd/m²), and 256 simultaneous shades of gray out of a palette of 4096, 8 DICOM look up table inside, the product is consisted of the following components: - 21.3 inch, mono-TFT Liquid Crystal Display - Motherboard HDVI-3M V1.0 - JUSHA-M52C Medical Display software - Power Adapter - Data Cable. The Medical Display is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards: 1. IEC 60601-1 Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance 1988+A1 : 1991 + A2:1995 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians
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)
The subject of this premarket submission, Medical Display, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
RADIFORCE G51:K042755
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
K131390
Page 1 of 3
·
510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | April 21,2013 | |
|---|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd | |
| Add: 301, Hanzhongmen Street, 8F Block A. No.1, Nanjing | ||
| International Service Outsourcing Mansion. Nanjing, 210036 | ||
| China | ||
| Primary Contact Person: | Mike Gu | |
| Regulatory Manager | ||
| Guangzhou Osmunda Medical Device Consulting Co., Ltd | ||
| Tel: +86-20-62321333 | ||
| Fax: +86-20-86330253 | ||
| Secondary Contact | ||
| Person: | Zhu chengshun | |
| Quality Manager | ||
| Nanjing Jusha Display Technology Co., Ltd | ||
| Tel: +86-25-83305050 | ||
| Fax: +86-25-58783271 | NOV 27 2013 | |
| Device Trade Name: | JUSHA-M52C Medical Display | |
| Common/Usual Name: | Image display system, medical image workstation, image | |
| monitor/display, and others | ||
| Classification Name: | ||
| Product Code: | System, image processing 21CFR 892.2050 | |
| 90LLZ | ||
| Predicate Device(s): | RADIFORCE G51:K042755 | |
| Device Description: | JUSHA-M52C Medical Display is the display system with | |
| the high resolution(2048 x 2560), high luminance(700 | ||
| cd/m²), and 256 simultaneous shades of gray out of a palette | ||
| of 4096, 8 DICOM look up table inside, the product is | ||
| consisted of the following components: |
- 21.3 inch, mono-TFT Liquid Crystal Display
- Motherboard HDVI-3M V1.0
- JUSHA-M52C Medical Display software
- Power Adapter
- Data Cable.
The Medical Display is designed, tested, and will be
manufactured in accordance with both mandatory and
voluntary standards:
- IEC 60601-1 Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential | |
| performance 1988+A1 : 1991 + A2:1995 | | |
| 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. | | |
| Intended Use: | JUSHA-M52C Medical Display is intended to be used by
trained physicians in various kinds of medical image
applications including digital mammography system for
which the device complies with the performance specified by
the manufacturer of the system. | |
| Technology: | JUSHA-M52C Medical Display is the display system with
the high resolution monitor (5 megapixels) with electronic
capabilities for evaluation of high resolution medical images,
high luminance (700 cd/m²) and 256 simultaneous shades of
gray out of a palette of 4096, 8 DICOM look up table inside | |
| Determination of
Substantial Equivalence: | Summary of Non-Clinical Tests:
The Medical Display complies with voluntary standards as
following:
1 IEC 60601-1 Medical equipment medical electrical
equipment - Part 1: General requirements for basic safety
and essential performance 1988+A1 : 1991 + A2:1995
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.
JUSHA-M52C is substantially equivalent to RadiForce G51.
G51. M52C employs the maximum resolution values same as
that of RadiForce G51. 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) | |
| (k) Premarket Notification Submission | | |
| | • Safety testing (Verification)
Summary of Clinical Tests:
The subject of this premarket submission, Medical Display, 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-M52C Medical Display to be as safe, as effective, and performance is substantially equivalent to the predicate device(s). | |
·
1
·
2
510(k
. . . . . .
and the comments of the comments of the comments of
3
Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a symbol that resembles a stylized human figure with outstretched arms, with three curved lines above it.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
November 27, 2013
Nanjing Jusha Display Technology Co., Ltd. % Mr. Mike Gu Regulatory Manager Guangzhou Osmunda Medical Device Consulting Co., Ltd. 710 Floor, 982 Congyun Road Baiyun District Guangzhou, Guangdong 510420 CHINA
Re: K131390
Trade/Device Name: JUSHA-M52C Medical Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 24, 2013 Received: September 30, 2013
Dear Mr. Gu:
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. The r ou may more or ovisions 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in and ation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2-Mr. Gu
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcessiorYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.hum.
Sincerely yours,
Sm. 7)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K131390
Device Name JUSHA-M52C Medical Display
Indications for Use (Describe)
JUSHA-MS2C Medical Display is intended to be used by trained physicians in various kinds of medical including digital mammography system for which the device complies with the performance specified by the manufacturer of the system.
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)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
PKC Palishing Seringer ( U1) 1 4614.741 ម