(115 days)
RADIFORCE R31;K052344
Not Found
No
The document describes a medical display and its components, focusing on image display and safety standards. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The "image processing" mention is likely standard display processing, not AI/ML-driven analysis.
No
The device is a medical display intended for viewing digital images for diagnosis, not for providing therapy.
No
The device is a medical display used for viewing digital images, not for performing diagnosis itself. Its intended use is to display images for diagnosis by trained medical practitioners.
No
The device description explicitly lists hardware components such as a display, motherboard, power adapter, and data cable, in addition to software.
Based on the provided information, the JUSHA-C31 Medical Display is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "displaying and viewing digital images for diagnosis of X-ray or MRI, etc." This involves presenting medical images to a trained medical practitioner for interpretation.
- Device Description: The description details a display screen, motherboard, software, power adapter, and data cable. These are components of a display system, not a device that analyzes biological samples or performs tests on specimens.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), reagents, or performing any kind of test or analysis on these samples.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The JUSHA-C31 Medical Display's function is to present pre-existing images, not to generate diagnostic information from biological samples.
N/A
Intended Use / Indications for Use
JUSHA-C31 Medical Display 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 must not be used for digital mammography system.
Product codes (comma separated list FDA assigned to the subject device)
90LLZ
Device Description
JUSHA-C31 Medical Display is 53cm(20.8") color medical display with the high resolution(2048 x 1536), the product is consisted of the following components: - 20.8 inch, Color Active Matrix TFT Liquid Crystal Display - Motherboard HDVI-3M V1.0 - JUSHA-C31 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 60601-1Medical 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests: The Medical Display complies with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. 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, 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.
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.
RADIFORCE R31;K052344
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).
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Image /page/0/Picture/0 description: The image shows a date, "SEP 0 6 2013". The month is September, the day is the 6th, and the year is 2013. The text is in a bold, sans-serif font. The image is a close-up of the date.
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 | |
Device Trade Name: | JUSHA-C31 Medical Display |
Common/Usual Name: | Image display system, medical image workstation, image |
monitor/display, and others | |
Classification Name: | |
Product Code: | System, image processing |
90LLZ | |
Predicate Device(s): | RADIFORCE R31;K052344 |
Device Description: | JUSHA-C31 Medical Display is 53cm(20.8") color medical |
display with the high resolution(2048 x 1536), the product is | |
consisted of the following components: |
- 20.8 inch, Color Active Matrix TFT Liquid Crystal Display
- Motherboard HDVI-3M V1.0
- JUSHA-C31 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 60601-1Medical equipment medical electrical
equipment - Part 1: General requirements for |
| | |
| | basic safety and essential performance 1988+A1:
1991 + A2:1995 - 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-C31 Medical Display 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 is
not specified for digital mammography system. |
| Technology: | JUSHA-C31 Medical Display is the display system with the
high resolution monitor (3 megapixels) with electronic
capabilities for evaluation of high resolution medical images,
high luminance (450 cd/m² max) and 16.7M(8-bits data per
R,G,B each)display color, 3 DICOM look up table inside |
| Determination of
Substantial Equivalence: | Summary of Non-Clinical Tests:
The Medical Display complies with voluntary standards as
detailed in Section 9, 11 and 17 of this premarket
submission. 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, 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-C31 Medical Display to be as safe, as effective, and
performance is substantially equivalent to the predicate
device(s). |
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K131389
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510(k) Premarket Notification Submission
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510(k) Premarket Notification Submission
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines representing its wings or feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Harnoshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 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: K131389
Trade/Device Name: Jusha-C31 Medical Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 23, 2013 Received: August 27, 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 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2-Mr. Gu
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/ResourcesforYou/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/ReportalProblem/dcfault.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.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Smh7)
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
Indications for Use
510(k) Number (if known): K 131389
Device Name: JUSHA-C31 Medical Display
Indications for Use:
JUSHA-C31 Medical Display 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 must not be used for digital mammography system.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Sm.h.7)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K131389
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