(18 days)
Not Found
No
The 510(k) summary describes a medical monitor, which is a display device. There is no mention of any software or processing capabilities that would suggest the use of AI or ML. The description focuses on the physical characteristics and display capabilities of the monitor.
No.
The device is a medical monitor used for displaying medical images for diagnosis, not for treating conditions.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is "to be used in displaying and viewing medical images for diagnosis by trained medical practitioners."
No
The device description explicitly states it is a 19-inch LCD monitor, which is a hardware component.
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 MDL1908A is a monitor used for displaying and viewing medical images. It does not perform any tests on biological samples. Its function is to present visual information to a medical practitioner for interpretation.
- Intended Use: The intended use clearly states it's for "displaying and viewing medical images for diagnosis." This is a display device, not a diagnostic test itself.
Therefore, the MDL1908A falls under the category of a medical image display device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
19-inch (48cm) 1.3M Monochrome LCD Monitor MDL1908A 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
MDL1908A is a 19-inch (48cm) 1.3 megapixel Monochrome LCD monitor that supports DVI video signal and provides UXGA (1280 x 1024) 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
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
K072066
510(k) SUMMARY
:
| Submitter Information: | TOTOKU ELECTRIC CO., LTD.
300 Oya, Ueda
Nagano 386-0192 Japan
AUG 1 4 2007 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mikio Hasegawa, General Manager
Email: hasegawam@totoku.co.jp
Tel:+81.268.34.5469
Fax:+81.268.34.5548 |
| Date Prepared: | July 24, 2007 |
| Device Name: | 19-inch (48 cm) 1.3M Monochrome LCD Monitor MDL1908A |
| Common Name: | MDL1908A |
| Classification Name: | Class II
(Part 892 Radiology Devices
Sec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 1.3M Monochrome LCD Monitor MDL1812A (ME183L) (K030272) |
| Device Description: | MDL1908A is a 19-inch (48cm) 1.3 megapixel Monochrome LCD
monitor that supports DVI video signal and provides UXGA (1280
x 1024) resolution for both landscape and portrait display. |
| Intended Use: | 19-inch (48cm) 1.3M Monochrome LCD Monitor MDL1908A 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. |
| Substantial Equivalence: | MDL1908A shares the same characteristics with our predicate
device ME183L (MDL1812A) (K030272) except for a board, LCD
panel, power supply. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 1 4 2007
Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd. 300 Ova, Ueda, Nagano, 386-0192 JAPAN
Re: K072066
Trade/Device Name: 1.3M Monochrome LCD Monitor MDL 1908A Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 24, 2007 Received: July 27, 2007
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 (Premarket Approval), 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.
Image /page/1/Picture/8 description: The image shows a circular logo with the text "1906-2006" at the top. Below the text is a large "DA" in a bold, blocky font. Underneath "DA" is the word "Centennial" in a cursive font. There are three stars at the bottom of the logo.
Protesting and Promoting Public Health
2
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 (OS) 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). 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/cdrl/industry/support/index.html.
Sincerely vours.
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
INDICATIONS FOR USE
510(k) Number: Not Known
Device Name: 1.3M Monochrome LCD Monitor MDL1908A Indications for Use:
19-inch (48cm) 1.3M Monochrome LCD Monitor MDL1908A is 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 X (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)
Dwhang 8/14/07
(Division Si (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number