(500 days)
No
The 510(k) summary describes a medical display monitor and does not mention any AI or ML capabilities. The focus is on the display technology and its intended use for viewing medical images.
No
The document states the device is a monitor intended for displaying and viewing medical images for diagnosis, not for therapeutic purposes.
No
The device is a monitor used for displaying and viewing medical images for diagnosis, not a diagnostic device itself.
No
The device description clearly identifies it as a physical hardware component (a 21.3-inch monochrome LCD monitor) intended for displaying medical images. It is 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 device described is a medical monitor used for displaying and viewing medical images (specifically digital mammography images). It does not perform any tests on biological samples.
- Intended Use: The intended use is for displaying images for diagnosis by trained medical practitioners, not for analyzing biological samples.
Therefore, this device falls under the category of a medical image display device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
21.3 inch (54cm) Monochrome Digital Mammography 3M pixel LCD Monitor with subpixel driving techniques enabling 9M subpixels to be driven independently, MS31i2 (MDL2128A) 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
MS31i2 (MDL2128A) is a 21.3-inch (54 cm) monochrome LCD monitor whose display resolution is 1536 x 6144 (landscape), 6144 x 1536 (portrait) supporting DVI (digital visual interface).
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. It is to be used in 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)
ME551i2 (MDL2116A) (K061447), MS51i2 (MDL2123A) (K071794)
Reference Device(s)
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
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:
K096947
P. 1 of 1
510(k) SUMMARY
| Submitter Information: | TOTOKU ELECTRIC CO., LTD.
300 Oya, Ueda
Nagano 386-0192 Japan | AUG 1 6 2010 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Mikio Hasegawa, General Manager
Email: hasegawam@totoku.co.jp
Tel:+81.268.34.5469
Fax:+81.268.34.5548 | |
| Date Prepared: | April 3, 2009 | |
| Device Name: | 21.3 inch (54 cm) Monochrome Digital Mammography LCD Monitor
MS31i2 (MDL2128A) | |
| Common Name: | MS31i2, MDL2128A | |
| Classification Name: | Class II
(Part 892 Radiology Devices
Sec. 892.2050 Picture Archiving and Communication System) | |
| Predicate Device: | 5M Monochrome Digital Mammography LCD Monitor ME551i2
(MDL2116A) (K061447) and MS51i2 (MDL2123A) (K071794). | |
| Device Description: | MS31i2 (MDL2128A) is a 21.3-inch (54 cm) monochrome LCD
monitor whose display resolution is 1536 x 6144 (landscape),
6144 x 1536 (portrait) supporting DVI (digital visual interface). | |
| Intended Use: | 21.3 inch (54cm) Monochrome Digital Mammography 3M pixel LCD
Monitor with sub-pixel driving techniques enabling 9M subpixels
to be driven independently, MS31i2 (MDL2128A) 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: | MS31i2 (MDL2128A) shares the same characteristics with our
predicate device ME551i2 (K061447) and MS51i2 (K071794) | |
Page
·
MS31i2 Premarket Notification
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Image /page/1/Picture/0 description: The image shows a logo for the Department of Health. The logo features a stylized abstract design, possibly representing a bird or a flowing shape, with three curved lines. The text "DEPARTMENT OF HEALTH" is vertically oriented and curved along the left side of the logo.
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
Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd. 300 Oya, Ueda, Nagano 386-0192 JAPAN
AUG 1 6 2010
Re: K090947
Trade/Device Name: 21.3 inch (54cm) Monochrome Digital Mammography LCD Monitor MS31i2 (MDL2128A)
Regulation Number: 21 CFR 892.2050
Regulation Name: Picture archiving and communications system
Regulatory Class: II.
Product Code: LLZ
Dated: June 25, 2010
Received: June 29, 2010
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 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
Enclosure
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,
Sincerely, yours,
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
3
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INDICATIONS FOR USE
AUG 16 2010
510(k) Number: Not Known
Device Name: 21.3 inch (54cm) Monochrome Digital Mammography LCD Monitor MS31i2 (MDL2128A)
Indications for Use:
21.3 inch (54cm) Monochrome Digital Mammography 3M pixel LCD Monitor with subpixel driving techniques enabling 9M subpixels to be driven independently, MS3112 (MDL2128A) 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)
(Division Sign-Off)
fice of Ir
K090947
-10K
TOTOKU ELECTRIC CO., LTD.