(205 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 algorithms beyond basic display adjustments.
No.
The device is a display monitor used for viewing medical images for diagnostic purposes, not for providing therapy.
Yes
The device is described as "Medical Display" which "displays image for medical use" and provides "adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, PACS and digital mammography system," indicating it is used in the diagnostic process.
No
The device description explicitly states it is a "20.1" monochrome LCD monitor" and a "Medical Display," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a medical display used to display medical images. It does not interact with or analyze biological specimens.
- Intended Use: The intended use is for displaying various medical images, including those from digital mammography systems, CT, MRI, etc. This is a display function, not an in vitro diagnostic function.
- Regulation Classification: The device is classified under "System, Image Processing, Radiological (CLASS II CFR 892.2050)". This classification is for devices that process and display radiological images, not for IVDs.
Therefore, this medical display is a device used in the interpretation of medical images, which is distinct from an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
5 MP Medical Monochrome Reference Display, MDM2010-5NC is intended to be used in various kinds of medical images applications including digital mammography system.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Medical Display, MDM2010-5NC is a 20.1" monochrome LCD monitor that displays image for medical use. It provides 5 mega pixel (2560*2048) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, PACS and digital mammography system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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
510(K) Summary of Safety and Effectiveness
MAY 2 3 2007
As required by 807.92
DEVICE ESTABLISHMENT AND CONTACT PERSON 1.
Phil Chen CHILIN TECHNOLOGY CO., LTD. No.71, Te Lun Road, Jen Te Hsian, Tainan County 717, Taiwan, R.O.C. Ph: +886-6-279 - 4113 ext. 533 Facsimile: +886-6-249 - 4751
DATE SUMMARY PREPARED 2.
28 June 2006
DEVICE NAME 3.
| Trade Name: | Medical Display, MDM2010-5NC |
|---|---|
| Common Name: | Monochrome LCD Monitor, Monochrome Diagnostic Display, etc. |
| Classification Name: | System, Image Processing, Radiological (CLASS II CFR 892.2050) |
PREDICATE DEVICE 4.
RadiRorce G51 21.3" 5MP Monochrome LCD Monitor by EIZO NANAO CORPORATION. (K042755).
DEVICE DESCRIPTION 5.
Medical Display, MDM2010-5NC is a 20.1" monochrome LCD monitor that displays image for medical use. It provides 5 mega pixel (2560*2048) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, PACS and digital mammography system.
DEVICE OF INTEND USE 6.
5 MP Medical Monochrome Reference Display, MDM2010-5NC is intended to be used in various kinds of medical images applications including digital mammography system.
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CONCLUSION 7.
Medical Display, MDM2010-5NC has the same intended use as the predicate device RadiForce G51, and they both share the similar characteristics except some minor differences which do not raise new questions of safety and effectiveness. The device does not contact with the patient nor does it control any life sustaining device. Therefore we concluded that it is substantially equivalent to RadiForce G51 by EIZO NANAO CORPORATION (K042755).
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Image /page/2/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three curved lines or strokes, possibly representing a stylized human figure or abstract design. The image is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Chi Lin Technology Co., Ltd. % Mr. Marc M. Mouser CAS Manager, Program Reviewer Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542
AAY 2 3 2007
Re: K063269
Trade/Device Name: Medical Display, MDM2010-5NC Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 18, 2007 Received: April 20, 2007
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image is a circular seal or logo. The text "1906-2006" is at the top of the seal. The letters "FDA" are in the center of the seal in a bold, stylized font. The word "Centennial" is below the letters "FDA". There are three stars below the word "Centennial".
High and Possmational
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Page 2 -
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); good manufacturing practice requirements as set 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.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Medical Display, MDM2010-5NC
Indications For Use: 5 MP Medical Monochrome Reference Display, MDM2010-5NC is intended to be used in various kinds of medical images applications including digital mammography system.
Prescription Use (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 Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __
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