(99 days)
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No
The document describes a medical display with standard display technology and software for image viewing, with no mention of AI or ML capabilities. The focus is on display specifications and compliance with safety standards.
No.
The device is a display for viewing medical images, not for providing therapy.
No
The device is a medical display, which is used to view digital images for diagnosis. The diagnosis is made by trained medical practitioners viewing the images, not by the device itself. Therefore, the display is a tool for diagnosis, rather than a diagnostic device in itself.
No
The device description explicitly lists hardware components such as a display, motherboard, power adapter, and data cable, in addition to the software.
Based on the provided information, the JUSHA-M32 Medical Display is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to display and view digital images from modalities like X-ray and MRI for diagnosis. This is related to medical imaging, not the examination of specimens derived from the human body.
- Device Description: The device is a display system with specific technical specifications for image presentation. It does not involve reagents, calibrators, control materials, or other components typically associated with IVD testing.
- Function: The device's function is to present visual information (medical images) to a trained medical practitioner for interpretation. It does not perform any analysis or testing of biological samples.
- Standards: The listed standards (IEC 60601-1 and IEC 60601-1-2) are general standards for medical electrical equipment, focusing on safety and electromagnetic compatibility. While relevant to medical devices, they are not specific to IVD devices, which would typically adhere to standards related to analytical performance and quality control of in vitro tests.
IVD devices are specifically designed to perform tests on specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The JUSHA-M32 Medical Display does not perform such tests. It is a medical imaging display device.
N/A
Intended Use / Indications for Use
JUSHA-M32 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.
Product codes (comma separated list FDA assigned to the subject device)
90LLZ, LLZ
Device Description
JUSHA-M32 Medical Display is the display system with the high resolution(2048 x 1536), 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-M32 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
- 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
System, image processing
Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray or MRI, etc.
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained medical practitioners.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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 GS310;K060845
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.
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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).
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§ 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
510(k) Premarket Notification Submission
AUG 2 1 2013
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | Mar, 11,2013 |
|---|---|
| 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: | Zhu chengshun |
| Quality Manager | |
| Nanjing Jusha Display Technology Co., Ltd | |
| Tel: +86-25- 83305050 | |
| Fax: +86-25- 58783271 | |
| Secondary Contact | |
| Person: | Mike Gu |
| Regulatory Manager | |
| Guangzhou Osmunda Medical Device Consulting Co., Ltd | |
| Tel: +86-20-62321333 | |
| Fax: +86-20-86330253 | |
| Device Trade Name: | JUSHA-M32 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 GS310;K060845 |
| Device Description: | JUSHA-M32 Medical Display is the display system with the |
| high resolution(2048 x 1536), 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-M32 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. |
| Intended Use: | JUSHA-M32 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-M32 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 (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
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-M32 Medical Display to be as safe, as effective, and
performance is substantially equivalent to the predicate
device(s). |
1
510(k) Premarket Notification Submission
2
510(k) Premarket Notification Submission
3
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is relatively small compared to the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2013
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD % MIKE GU GUANGZHOU OSMUNDA MEDICAL DEVICE CONSULTING CO. 7TH FLOOR, 982. CONGYUN RD. BAIYUN DISTRICT GUANGZHOU, GUANGDONG CHINA CH 510420
Re: K131391
Trade/Device Name: JUSHA-M32 Medical Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: July 15, 2013 Received: August 9, 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
4
Page 2 - Mr. Mike 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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): K131391
Device Name: JUSHA-M32 Medical Display
Indications for Use:
JUSHA-M32 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.
Prescription Use JJ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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)
(m.h.p)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K131391 510(k)_