(104 days)
Not Found
No
The summary describes a medical monitor for displaying images, with no mention of AI/ML features or image processing capabilities beyond basic display technology.
No
The device is a medical image display monitor used for diagnostic purposes by medical practitioners, not for therapy.
No
The device is a monitor intended for displaying and viewing medical images for diagnosis, not for performing the diagnosis itself.
No
The device description explicitly states it is a 20.8-inch monochrome LCD monitor, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "displaying and viewing medical images for diagnosis by trained medical practitioners." This describes a device used for presenting visual information, not for performing tests on biological samples to obtain diagnostic information.
- Device Description: The device is described as a "monochrome LCD monitor." This is a display device, not a device that interacts with biological samples.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, tissue, etc.)
- Reagents or assays
- Generating quantitative or qualitative results from biological tests
The device is a medical image display monitor, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
20.8 inch Monochrome Digital Mammography 3M pixel LCD Monitor with subpixel driving techniques enabling 9M subpixels to be driven independently, MS33i2 (ML21033) 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 (comma separated list FDA assigned to the subject device)
LLZ
Device Description
MS33i2 (ML21033) is a 20.8-inch monochrome LCD monitor whose display resolution is 1536 x 2048 (landscape), 2048 x 1536 (portrait) supporting DVI (digital visual interface) and DisplayPort.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Not Found
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.
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
TOTOKU
NOV - 7 2011
KI12145
510(k) SUMMARY
| Submitted Information: | TOTOKU ELECTRIC CO., LTD.
300 Oya, Ueda
Nagano 386-0192 Japan |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tsukasa Tashiro, General Manager
Email: tasirot@totoku.co.jp
Tel: +81.258.24.6611
Fax: +81.258.24.6617 |
| Date Prepared: | June 20, 2011 |
| Device Name: | 20.8 inch Monochrome Digital Mammography LCD Monitor MS33i2
(ML21033) |
| Common Name: | MS33i2, ML21033 |
| Classification Name: | Class II
(Part 892 Radiology Devices
Sec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 21.3 inch (54 cm) Monochrome Digital Mammography LCD Monitor
MS31i2 (MDL2128A) (K090947). |
| Device Description: | MS33i2 (ML21033) is a 20.8-inch monochrome LCD monitor whose
display resolution is 1536 x 2048 (landscape), 2048 x 1536
(portrait) supporting DVI (digital visual interface) and DisplayPort. |
| Intended Use: | 20.8 inch Monochrome Digital Mammography 3M pixel LCD
Monitor with sub-pixel driving techniques enabling 9M subpixels to
be driven independently, MS33i2 (ML21033) 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: | MS33i2 (ML21033) shares the same characteristics with our
predicate device MS31i2 (K090947) except for the main board,
LCD panel and power supply. |
1
Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three swooping lines representing its wings and tail. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
NOV - 7 2011
Mr. Tsukasa Tashiro General Manager TOTOKU Electronic Co., Ltd. 300 Oya, Ueda, Nagano 386-0192 JAPAN
Re: K112145 Trade/Device Name: 20.8 inch Monochrome Digital Mammography LCD Monitor MS33i2 (ML21033) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 22, 2011 Received: October 14, 2011
Dear Mr. Tashiro:
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 (reporting of
2
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
3
INDICATIONS FOR USE
510(k) Number: Not known
. :
Device Name: 20.8 inch Monochrome Digital Mammography LCD Monitor MS33i2 (ML21033)
Indications for Use:
20.8 inch Monochrome Digital Mammography 3M pixel LCD Monitor with subpixel driving techniques enabling 9M subpixels to be driven independently, MS33i2 (ML21033) 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.
Image /page/3/Picture/5 description: The image shows the words "Prescription Use" next to a check mark. The check mark is large and black, and it is placed to the right of the words. The words are in a smaller font and are in black as well. The check mark indicates that the prescription use option has been selected.
AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mamy Patil
Divisio Office of In Vitro Diag
510K K112145