(63 days)
Not Found
No
The document describes a medical display monitor and does not mention any AI or ML capabilities.
No
The device is a display monitor for viewing medical images for diagnosis, not for treating conditions.
No
The device is described as a display for viewing digital images for diagnosis, but it does not perform the diagnosis itself. Its function is limited to displaying images for practitioners to interpret.
No
The device description explicitly states it is a "61cm Color LCD display," which is a hardware component.
Based on the provided information, the RadiForce MX241W is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- RadiForce MX241W's Intended Use: The intended use clearly states that the device is for "displaying and viewing digital images for diagnosis of X-ray or MRI, etc." This involves displaying images generated by other medical devices, not analyzing biological specimens.
- Device Description: The device is described as a "Color LCD display for medical image viewing." This further reinforces its role as a display device, not a diagnostic test performed on biological samples.
Therefore, the RadiForce MX241W falls under the category of a medical image display device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
RadiForce MX241W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
RadiForce MX241W is 61cm Color LCD display for medical image viewing digital images viewing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray or MRI, etc.
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
K092 741
510(k) Summary as required by 807.92
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- Company Identification
NOV 1 0 2009
- Company Identification
EIZO NANAO CORPORATION 153 Shimokashiwano-cho, Hakusan, Ishikawa-ken, 924-8566, Japan Tel: +81-76-274-2468 Fax: +81-76-274-2484
-
- Official Correspondent
Hiroaki Hashimoto (Mr.) Manager of Engineering Management Section
- Official Correspondent
- Date of Submission
September 4, 2009
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- Device Trade name Color LCD Monitor, RadiForce MX241W
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- Common/Usual Name:
Image display system, medical image workstation, image monitor/display, and others
-
- Classification Number:
Medical displays classified in Class II per 21 CFR 892.2050.
- Classification Number:
7. Predicate Device
| Manufacturer | : EIZO NANAO CORPORATION | |
|---|---|---|
| Device Name | : Color LCD Monitor | |
| Model Name | : FlexScan MX300W | |
| 510(k) No. | : K073340 |
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- Description of Device
RadiForce MX241W is 61cm Color LCD display for medical image viewing digital images viewing.
- Description of Device
-
- Intended Use
RadiForce MX241W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.
- Intended Use
-
- Substantial Equivalence to Predicate Device
RadiForce MX241W is substantially equivalent to FlexScan MX300W (K073340). The panel size is changed to 61 cm (24.1") from 76cm (29.8"). MX241W improved the brightness. The brightness improved to 320 cd/m2 from 300 cd/m2. DisplayPort is added as new input terminal.
- Substantial Equivalence to Predicate Device
Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1. Appendix 1: Comparison Table with Predicate Device
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a stylized eagle. The eagle is depicted with its wings spread, and its head turned to the left. The text 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 1 0 2009
Mr. Hiroaki Hashimoto Manager EIZO NANAO Corporation, Engineering Management Section 153 Shimokashiwano-cho, Hakusan, Ishikawa-ken 924-8566 JAPAN
Re: K092741
Trade/Device Name: Color LCD Monitor, RadiForce MX241W Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 21, 2009 Received: October 22, 2009
Dear Mr. Hashimoto:
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 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.
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); medical device reporting (reporting of medical
2
Page 2 -
Enclosure
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.html
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
(k) Number:
ëvice Name . . Color LCD Monitor, RadiForce MX241W
dications for Use:
RadiForce MX241W is intended to be used in displaying and viewing digital images for Radil ore MX24117 - Is there and medical practitioners. RadiForce MX241W does not support the display of mammography images for diagnosis.
escription Use art 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aorri m. Wh
Division of Reproductive, Abdominal and Radiological Dev 510(k) Number