(224 days)
Not Found
No
The summary describes a medical display monitor and its technical specifications. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies for image analysis or interpretation. The focus is on the display hardware itself.
No
The device is a monitor intended for displaying medical images for diagnosis, not for providing therapy or treatment.
Yes
The device is a monitor intended for displaying and viewing medical images for diagnosis by trained medical practitioners. While it doesn't perform the diagnosis itself, it is an essential tool for the diagnostic process.
No
The device is a physical monitor (LCD monitor) and not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a monitor intended for displaying and viewing medical images for diagnosis. It receives input from digital mammography PACS and modalities.
- Lack of Biological Sample Interaction: The device does not interact with or analyze biological samples. Its function is purely to present visual information derived from imaging equipment.
Therefore, while it is a medical device used in the diagnostic process, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
21.3 inch (53cm) Monochrome Digital Mammography LCD Monitor with additional sub-pixel driving techniques designed to improve image quality, MS51i2 (MDL2123A) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.
Product codes
LLZ
Device Description
MS51i2 (MDL2123A) is a 21.3-inch (53cm) monochrome LCD monitor whose display resolution is 2048 x 7680 (landscape), 7680 x 2048 (portrait) supporting DVI (digital visual interface).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital mammography, FFDM
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners / digital mammography PACS and modalities including FFDM
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
TOTUKU
510(k) SUMMARY
77 -- 1
Submitter Information: TOTOKU ELECTRIC CO., LTD. 300 Oya, Ueda Nagano 386-0192 Japan
Contact Person: Mikio Hasegawa, General Manager Email: hasegawam@totoku.co.jp Tel: +81.268.34.5469 Fax: +81.268.34.5548
Date Prepared: June 29, 2007
21.3 inch (53cm) Monochrome Digital Mammography LCD Monitor Device Name: MS51i2 (MDL2123A)
Common Name: MS51i2 (MDL2123A)
Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
5M Monochrome Digital Mammography LCD Monitor ME551i2 Predicate Device: (MDL2116A) (K061447)
Device Description: MS51i2 (MDL2123A) is a 21.3-inch (53cm) monochrome LCD monitor whose display resolution is 2048 x 7680 (landscape), 7680 x 2048 (portrait) supporting DVI (digital visual interface).
- 21.3 inch (53cm) Monochrome Digital Mammography LCD Monitor Indended Use: with additionalsub-pixel driving techniques designed to improve image quality, MS51i2 (MDL2123A) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.
- Substantial Equivalence: MS51i2 (MDL2123A) shares the same characteristics with our predicate device ME551i2 (K061447) except for a newly-developed Independent Sub-pixel Drive (ISD), AR (Anti-Reflection) special coating panel and firmware to display driver by FPGA.
MDL2123A Premarket Notification
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 11 2008
Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd. 300 OYA, Ueda Nagano, 386-0192 JAPAN
Re: K071794
Trade/Device Name: 21.3 inch (53 cm) Monochrome Digital Mammography LCD Monitor MS51i2 (MDL2123A)
Regulation Number: 21 CFR 892.2050
Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 25, 2008 Received: January 28, 2008
Dear Mr. Hasegawa:
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 (PMA), 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.
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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrt/industry/support/index.html.
Sincerely yours.
Nancy C. Brogdon
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: Not Known
Device Name: 21.3 inch (53 cm) Monochrome Digital Mammography LCD Monitor MS51i2 (MDL2123A)
Indications for Use:
21.3 inch (53 cm) Monochrome Digital Mammography LCD Monitor with additional sub-pixel driving techniques designed to improve image quality, MS51i2 (MDL2123A) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.
Prescription Use (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jorge Th. W.
(Division Sign-Division of Reproductive, Abdominal and Radiological Devices 510(k) Number