(44 days)
Not Found
No
The summary describes a medical display monitor and its technical specifications, with no mention of AI, ML, or related concepts like image analysis or diagnostic algorithms.
No
The device is a display monitor used for viewing diagnostic images; it does not directly treat or alleviate a medical condition.
Yes
The device is explicitly stated to be for "displaying and viewing of digital images for diagnosis by trained physicians" and for "more precise diagnose use in CT, MRI, HIS, and PACS". Furthermore, its predicate device is a "Diagnostic Imaging LCD monitor".
No
The device description explicitly states it is a "29.8" Color LCD monitor," which is a hardware component.
Based on the provided information, the MD301C4 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "displaying and viewing of digital images for diagnosis by trained physicians." This describes a device used to present medical images, not a device that performs tests on biological samples (which is the core function of an IVD).
- Device Description: The description clearly states it's a "Color LCD monitor that displays image for medical use." This reinforces its role as a display device.
- Mentions image processing: While it mentions "System, Image Processing, Radiological," this refers to the type of system it's part of (radiological imaging systems), not that the display itself is performing image processing on biological samples.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, reagents, calibrators, or controls, which are typical components and functions of IVD devices.
The device is a medical display intended for use in radiology and other medical imaging contexts. Its function is to present images generated by other medical devices (like CT or MRI scanners) for interpretation by physicians. This falls under the category of medical imaging display devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
MD301C4 is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.
Caution: MD301C4 cannot be used for a life-support system.
This unit is designed as component of a final system which is compliance to IEC60601-1-1 requirements.
MD301C4 must not be used in digital mammography.
Product codes
LLZ
Device Description
Medical Display, MD301C4 is a 29.8" Color LCD monitor that displays image for medical use. It provides 4 mega pixel (2560*1600) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS. MD301C4 conforms with DICOM.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI, HIS, and PACS
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
JUN 1 5 2018
510(K) Summary of Safety and Effectiveness
As required by 807.92
DEVICE ESTABLISHMENT AND CONTACT PERSON 1.
Mr. Shuichi Kino Manager NEC Display Solutions Ltd. 4-13-23 Shibaura, Minato-ku, Tokyo, 108-0023 Japan Ph: +81-465-85-2376 Fax: +81-465-85-2378
2. COMPANY REISTRATION NUMBER
3003623028
..............................................................................................................................................................................
3. DATE SUMMARY PREPARED
09 February 2011
4. DEVICE NAME
| Trade Name: | MD301C4 29.8" Diagnostic Imaging LCD monitor |
|---|---|
| Model Name: | L309TY |
| Common Name: | Color LCD Monitor, Color Diagnostic Display, etc. |
| Classification Name: | System, Image Processing, Radiological (CLASS II CFR 892.2050) |
4. PREDICATE DEVICE
MD304MC 29.8" 4MP Color LCD Monitor by NEC Display Solutions Ltd. (K083916). Trade Name: MD304MC 29.8" Diagnostic Imaging LCD monitor L307TD Model Name:
DEVICE DESCRIPTION క.
Medical Display, MD301C4 is a 29.8" Color LCD monitor that displays image for medical use. It provides 4 mega pixel (2560*1600) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS. MD301C4 conforms with DICOM.
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INDICATION OF USE 6.
..
MD301C4 is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.
Caution: MD301C4 cannot be used for a life-support system.
This unit is designed as component of a final system which is compliance to IEC60601-1-1 requirements.
MD301C4 must not be used in digital mammography.
7. CONCLUSION
Device with trade name MD301C4 (model name is L309TY) and predicate device with trade name MD304MC (model name is L307TD) have the same target population of trained practitioner in hospital; it shares the same design, same performance and is the same in radiation safety (EN60601-1-2), mechanical safety, electrical safety (UL60601-1) and human factors. It uses similar material, and has same compatibility with environment and other devices. The differences between the two devices are display colors (MD304MC can display more colors), input signals, input terminals, and USB input, power consumes in power save mode (MD301C4 consumes less power in power save mode), power consumption (MD301C4 consumes more power), however these do not effect the safety and effectiveness of the MD301C4 to be substantially equivalent to the predicate device. These two devices also have the same intended use; Therefore we concluded that it is substantially equivalent to MD304MC by NEC Display Solutions Ltd. (K083916).
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
NEC Display Solutions Ltd. % Mr. Marc Mouser Engineering Leader/ FDA Office Coordinator Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542
JUN 1 5 2011
Re: K111237
Trade/Device Name: Medical Display, MD301C4 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 25, 2011 Received: June 3, 2011
Dear Mr. Mouser:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
5:10(k) Number (if known):
Device Name: Medical Display, MD301C4
Indications For Use: MD301C4 is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.
Caution: MD301C4 cannot be used for a life-support system. This unit is designed as component of a final system which is compliance to IEC60601-1-1 requirements. MD301C4 must not be used in digital mammography.
Prescription Use Over-The-Counter Use X (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Postel
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K///237
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