(43 days)
Not Found
No
The 510(k) summary describes a monochrome LCD monitor for displaying medical images and does not mention any AI or ML capabilities.
No
The device is a monitor used for displaying medical images in conjunction with a PACS system. It does not perform any therapeutic function on a patient.
No
The device is described as a "Monochrome LCD Monitor" to be used with a "picture archiving communication system (PACS) for medical imaging applications." It displays medical images but does not perform any direct analysis, interpretation, or diagnosis. Its function is to render images, which is a display function, not a diagnostic one.
No
The device description explicitly states it is a "21.3-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 clearly states it's a monitor for medical imaging applications in conjunction with a PACS system. This is for displaying medical images, not for performing tests on biological samples.
- Device Description: The description details a monitor with specific technical specifications for displaying images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This monitor's function is to display images generated by other medical devices, not to analyze biological samples.
N/A
Intended Use / Indications for Use
21.3-inch (54cm) Monochrome LCD Monitor MDL2109A (ME251i) (DV2MM-HB) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
21.3-inch (54cm) Monochrome LCD Monitor MDL2109A (ME251i) (DV2MM-HB) is a 21.3-inch Monochrome LCD Monitor that supports DVI video signal and provides UXGA (1200 x 1600) resolution for both landscape and portrait display.
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
Not Found
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.
MDL2108A (K040695)
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
Image /page/0/Picture/0 description: The image shows a date, "APR 2 2 2005". The month is April, the day is the 2nd, and the year is 2005. The text is in a bold, sans-serif font. The text is black against a white background.
Image /page/0/Picture/1 description: The image shows the word "TOTOKU" in a bold, sans-serif font. The letters are black against a white background. There are two horizontal lines below the word.
XXXXXLL17
510(k) SUMMARY
TOTOKU ELECTRIC CO., LTD. Submitter Information: 300 Oya, Ueda Nagano 386-0192 Japan
Mikio Hasegawa, General Manager Contact Person: Email: hasegawam@totoku.co.jp +81.268.34.5469 Tel: Fax: +81.268.34.5565
Date Prepared: March 7, 2005
Device Name: 21.3-inch (54cm) Monochrome LCD Monitor MDL2109A (ME251i) (DV2MM-HB)
MDL2109A, ME251i, DV2MM-HB, 2M Monitor/Display Common Name:
Classification Name: Class II (Part892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
MDL2108A (K040695) Predicate Device:
- MDL2109A (ME251i) (DV2MM-HB) is a 21.3-inch Monochrome LCD Monitor Device Description: that supports DVI video signal and provides UXGA (1200 x 1600) resolution for both landscape and portrait display.
- Intended Use: 21.3-inch (54cm) Monochrome LCD Monitor MDL2109A (ME251i) (DV2MM-HB) is to be used in conjunction with the picture archiving communication system (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
- MDL2109A (ME251i) (DV2MM-HB) has almost the same characteristics as Substantial Equivalence: TOTOKU's predicate device MDL2108A (K040695) except for the molds and the front sensor, which has been newly placed.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
APR 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd MM Company, Design Group 300 Oya, Ueda, Nagano 386-0192 JAPAN
Re: K050617 K050017
Trade/Device Name: 21.3-inch (54cm) Monochrome LCD Monitor MDL2109A (ME251i) (DV2MM-HB) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems ﯿﮟ Regulatory Class: II Product Code: LLZ Dated: March 7, 2005 Received: March 10, 2005
Dear Mr. Hasegawa:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced We have reviewed your Section 510(t) premarked (for the indications for use stated in
above and have determined the device is substantially equivalse commerce prior to above and nave determined the devices its as a devices marketed in interstate commerce prior to re the enclosure) to legally marketed predical Device Amendments, or to devices that have been
May 28, 1976, the enactment date of the Medical East, Dave and Cormetic Act (Act) May 28, 1976, the enactilient date of the Frederal Food, Drug, and Cosmetic Act (Act) that reclassified in accordance with the provisions of application (PMA). You may, therefore, market the A do not require approval of a prematics approvat approvations of the general controls provisions of the Act.
device, subject to the general controls provisions of the Act. The device, subject to the general controls of devices, good manufacturing practice, labeling, merade roquires against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Prematket If your device is classified (sec above) into entrols. Existing major regulations affecting your Approval), it may be subject to such additional controls. Elitle 21, Parts 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 21, Pa device can be found in the Code of Perceiven in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA s Issualice of a substition in the requirements of the Act or ally
FDA has made a determination that your device complies. You must comply with all FDA has made a delemination mat your device ochip.Federal agencies. You must comply with all the Federal statutes and regulations administered by other in toon and listing (21 CFR Part 807); labeling Act's requirements, including, but life interests as set forth in the quality systems (QS)
(21 CFR Part 801); good manufacturing practice requirements as set of provisions (21 CFR Part 801); good namuaciante practice rocessories in the electronic product radiation control provisions
regulation (21 CFR Part 820); and if applicable, the electroni (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
This letter will allow you to begin marketing your device as described in your Section 510(k)
. It is a legal and the many of all startial sequalence of your device to a lega This letter will allow you to begin maketing your antine equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and this n premarket notification. The FDA linding of substantial equiralent of 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 If you desire specific advice for your device on our labeling regarantes as a common 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" (21 CFR Also, please note the regulation entitled, "Misolaliung on your responsibilities under the Act from the 807.97). You may obtain other general information on your responsibility of the number (800)
Division of Small Manufacturers, International Incon Division of Small Manats97 or at its Internet address 658-2041 of (2017) + 15th/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
3
TOTUK
INDICATIONS FOR USE
510(k) Number: Not Known
Device Name: 21.3-inch (54cm) Monochrome LCD Monitor MDL2109A (ME251i) (DV2MM-HB).
Indications for use:
21.3-inch (54cm) Monochrome LCD Monitor MDL2109A (ME251i) (DV2MM-HB) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
Prescription Use_V (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)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050617
MDL2109A Premarket Notification
TOTOKU ELECTORIC CO. 300 OYA, UEDA, NAGANO, 386-0192 JAPAN