(66 days)
Not Found
No
The summary describes a medical monitor for displaying images and does not mention any AI/ML capabilities or image processing features.
No
The device is a monitor intended for displaying and viewing medical images for diagnosis, not for providing therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners."
No
The device description explicitly states it is a "21.3-inch (54 cm) 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 "displaying and viewing medical images for diagnosis by trained medical practitioners." This describes a device used for visualizing images, not for performing tests on biological samples (which is the core function of an IVD).
- Device Description: The description details a monitor, a display device.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information about a patient's health status based on laboratory tests
This device is a medical image display monitor, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
21.3-inch (54cm) Monochrome LCD Monitor with sub-pixel driving techniques enabling 6M subpixels to be driven independently, MS21i2 (MDL2127A) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
Product codes
LLZ
Device Description
MS21i2 (MDL2127A) is a 21.3-inch (54 cm) Monochrome LCD monitor whose display resolution is 1200 x 4800 (landscape), 4800 x 1200 (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
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
Not Found
Key Metrics
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
K08:i945
SEP 1 2 2008
510(k) SUMMARY
TOTOKU ELECTRIC CO., LTD. Submitter Information: 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 30, 2008
21.3-inch (54 cm) Monochrome LCD Monitor MS21i2 (MDL2127A) Device Name:
MS21i2 (MDL2127A) Common Name:
Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
Predicate Device: 21.3-inch (54cm) Monochrome LCD Monitor MDL2121A (ME253i2) (K063198) 21.3-inch (53cm) Monochrome LCD Monitor MS51i2 (MDL2123A) (K081242)
Device Description: MS21i2 (MDL2127A) is a 21.3-inch (54 cm) Monochrome LCD monitor whose display resolution is 1200 x 4800 (landscape), 4800 x 1200 (portrait) supporting DVI (digital visual interface).
21.3-inch (54 cm) Monochrome LCD Monitor with sub-pixel driving Indended Use: techniques enabling 6M subpixels to be driven independently, MS21i2 (MDL2127A) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
MS21i2 (MDL2127A) shares the same characteristics with our Substantial Equivalence: predicate devices, ME253i2 (MDL2121A) (K063198) and MS51i2 (MDL2123A) (K081242) except for bezel, enclosure and main board (driver board).
MDL2127A Premarket Notification
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2008
Mr. Mikio Hascgawa General Manager TOTOKU Electric Co., Ltd. Intelligent Devices and Solutions Division 300 Oya, Ueda, Nagano 386-0192 JAPAN
Re: K081945
Trade/Device Name: 21.3-inch (54 cm) Monochrome LCD MS21i2 (MDL2127A) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 30, 2008 Received: July 8, 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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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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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/cdrh/industry/support/index.html.
Sincerely yours.
Jorque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number: Not Known
Device Name: 21.3-inch (54 cm) Monochrome LCD Monitor MS21i2 (MDL2127A)
Indications for Use:
21.3-inch (54cm) Monochrome LCD Monitor with sub-pixel driving techniques enabling 6M subpixels to be driven independently, MS21i2 (MDL2127A) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.
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)
Halina Pluma
(Division Sidn-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number