(21 days)
No
The summary describes a medical display monitor and does not mention any AI or ML capabilities.
No.
The device is a display for diagnostic images, not a tool that provides therapy or treatment.
No
Explanation: The device is described as a display for digital images (X-ray or MRI) for diagnosis, but it does not perform the diagnosis itself. Its function is to display images for human interpretation.
No
The device description explicitly states it is a "Color LCD display," which is a hardware component.
Based on the provided information, the FlexScan MX300W 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.
- FlexScan MX300W's Function: The FlexScan MX300W is a display device. Its purpose is to display digital images (X-ray, MRI, etc.) for diagnosis. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for "displaying digital images for diagnosis". This is a display function, not an in vitro diagnostic test.
Therefore, the FlexScan MX300W falls under the category of a medical image display device, not an IVD.
N/A
Intended Use / Indications for Use
FlexScan MX300W is intended to be used in displaying digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. FlexScan MX300W does not support the display of mammography images for diagnosis.
FlexScan MX300W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. FlexScan MX300W does not support the display of mammography images for diagnosis
Product codes
LLZ
Device Description
FlexScan MX300W is a 76cm (29.8") Color LCD display for medical image viewing and digital images viewing. MX300W displays high-definitions medical imaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray or MRI
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)
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
510(k) Summary as required by 807.92
1. Company Identification
DEC 1 9 2007
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
- Date of Submission
· · November 27, 2007
- Device Trade name Color LCD Monitor, FlexScan MX300W
5. Common/Usual Name
Image display system, medical image workstation, image monitor/display, and others
6. Classification Number
Medical displays classified in Class II per 21 CFR 892.2050.
7. Predicate Device
: EIZO NANAO CORPORATION Manufacturer Device Name : Color LCD Monitor Model Name : RadiForce R31 510(k) No. : K052344
8. Description of Device
FlexScan MX300W is a 76cm (29.8") Color LCD display for medical image viewing and digital images viewing. MX300W displays high-definitions medical imaging.
9. Intended Use
FlexScan MX300W is intended to be used in displaying digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. FlexScan MX300W does not support the display of mammography images for diagnosis.
10. Technological Characteristics
FlexScan MX300W is substantially equivalent to RadiForce R31 (K052344). The panel size became big with 76cm (29.8") from 53cm (20.8"). MX300W employs the maximum resolution values same as that of R31. Additional product innovations include Digital Uniformity Equalizer (DUE), which enables compensates for fuminance non-uniformity. And the brightness improved. Comparison table of the principal characteristics of 2 devices is shown in the Appendix 1.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is depicted in a simple, graphic style.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2007
Mr. Hiroaki Hashimoto Manager EIZO NANAO CORPORATION Engineering Management Section 153 Shimokashiwano-cho Hakusan, Ishikawa-ken 924-8566 JAPAN
Re: K073340
Trade/Device Name: Color LCD Monitor, FlexScan MX300W Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 22, 2007 Received: November 28, 2007
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 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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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/cdrb/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
510(k) Number: K073340
Device Name : Color LCD Monitor, FlexScan MX300W
Indications for Use:
FlexScan MX300W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. FlexScan MX300W does not support the display of mammography images for diagnosis
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lord McWhany
sion Sion-Off) (Div Division of Reproductive, Abdominal and Radiological Device 510(k) Num