(114 days)
Not Found
No
The document describes a medical display monitor and its technical specifications, with no mention of AI or ML capabilities for image analysis or processing beyond standard display functions.
No.
The device is a display panel for viewing medical images for diagnosis, not a device that applies therapy or treatment.
No
This device is a display for viewing medical images, not a device that directly performs diagnostic analysis or image processing. Its role is to present data for human interpretation.
No
The device description explicitly states it is a "diagnostic 5MP grayscale flat panel display," 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 for displaying and viewing digital images for review, analysis, and diagnosis by trained medical practitioners. This describes a device used to present visual information, not a device that performs tests on biological samples (in vitro).
- Device Description: The description focuses on the technical specifications of a display (grayscale, resolution, gamma response, DVI compatibility) and its use in viewing medical images. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Measurement of analytes
- Diagnostic tests performed on samples outside the body
The device is a medical display intended for the visualization of medical images, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The 5MP Grayscale Flat Panel Display is intended to be used in displaying and viewing digital images, including digital mammography, for review, analysis and diagnosis by trained medical practitioners.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The 6GF6201-5C$2# is a diagnostic 5MP grayscale flat panel display for viewing medical images. With the calibrated gamma response stored in five internal lookup tables, the display is suitable for use with a wide range of DVI graphic controller boards. The display can be used in single-head or multi-head configurations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital images, including digital mammography
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The overall design of the 6GF6201-5C$2# was validated in accordance with internationally recognized safety and EMC standards by independent testing facilities. Additionally, EIZO GmbH performed a range of system and performance tests to ensure that the 5MP Grayscale Flat Panel Display performed in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance of a 5MP grayscale flat panel display.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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).
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§ 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).
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Image /page/0/Picture/0 description: The image shows a logo for EIZO. The logo consists of the word "EIZO" in a bold, sans-serif font, with a small registered trademark symbol next to it. Above the word, there is a stylized graphic that resembles a checkered pattern or a pixelated design. The graphic is black and white and has a slightly jagged or uneven edge, giving it a textured appearance.
SEP - 5 2008
| Eizo GmbH, Siemensallee 84, 76187 Karlsruhe | Name | James Berge |
|---|---|---|
| Department | PM | |
| Food and Drug Administration | ||
| Center for Devices and Radiological Health (HFZ-401) | Telephone | +49 (721) 595-5227 |
| 9200 Corporate Blvd. | Fax | +49 (721) 595-2250 |
| Rockville, MD, USA | james.berge@eizo.com | |
| 20850 | Date | 6 May 2008 |
510(k) Summary (in accordance with 21 CFR 807.92)
1. Date of Summary 6 May, 2008
-
- Company
EIZO GmbH Siemensallee 84 D-76187 Karlsruhe, Germany
- Company
-
- Authorized Contact Person James Berge
4. Device Information
- Trade Name/Model: 6GF6201-5C$2# (where $ = A-Z and # = 0-9) .
- Common Name: Display, 5MP Grayscale Flat Panel Display ●
- System, Image Processing Classification Name: .
- Classification Number: 21 CFR 892.2050, Product Code LLZ .
5. Predicate Devices
6. Device Description
The 6GF6201-5C$2# is a diagnostic 5MP grayscale flat panel display for viewing medical images. With the calibrated gamma response stored in five internal lookup tables, the display is suitable for use with a wide range of DVI graphic controller boards. The display can be used in single-head or multi-head configurations.
7. Intended Use
The 5MP Grayscale Flat Panel Display is intended to be used in displaying and viewing digital images, including digital mammography, for review, analysis and diagnosis by trained medical practitioners. Patients do not come into contact with the display does not control any life-sustaining devices.
Office/Delivery addres Eizo GmbH Siemensallee 84 76187 Karlsruhe Tel .: +49 (721) 595-0000 Fax: +49 (721) 595-0000
Postal address Eizo GmbH 6181 Karlsruhe
Internet: http://www.eizo.eu
Management: Peter Ziegler Dr. Eberhard Lange Commercial registries: Karlsruhe Registergericht Mannheim HRB 703009 WEEE-Rea-Nr. DE 75807507
510(k) Summary.doc
Section 5: Page 1 of 2
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Image /page/1/Picture/1 description: The image is a black and white logo for EIZO. The logo consists of two parts: a stylized graphic at the top and the word "EIZO" at the bottom. The graphic appears to be a stylized representation of a checkered pattern, possibly suggesting a display screen or pixel arrangement. The word "EIZO" is written in a bold, sans-serif font.
8. Technological Characteristics
The SMP Grayscale Flat Panel Display uses a monochrome LCD panel employing in-plane switching (IPS) technology to allow wide viewing angles. It has a resolution of 2048x2560 pixels and can be used in portrait and landscape modes. The display uses an integrated luminance sensor (ISS) to automatically stabilize the set luminance levels of the CCFL backlight over time. It also sports a front luminance sensor (ICS) for independent grayscale verification. The factory calibrated gamma response is stored in five lookup tables located in the display, allowing users to adapt the display to local lighting conditions and ensuring that the display function is DICOM compliant regardless of the display controller used.
The 5MP Grayscale Flat Panel Display will be offered both with and without an optional protective glass screen and may be offered in different housing colors. These cosmetic differences are reflected in the designators represented by the characters "$" and "#" included in the model trade name 6GF6201-5C$2#, where $ represents a letter between A and Z, and # is a number between 0 and 9.
The 5MP Grayscale Flat Panel Display uses the same LCD panel as the predicate devices and employs CCFL backlight technology. It is equipped with two integrated luminance sensors, one mounted rear center, as designed in the Nio 5MP-M-21", and a built in front sensor, as included with the Coronis 5MP.
The housing, stand, electronics and the integrated luminance sensors are not the same as those components used in the predicate devices. The overall design of the 6GF6201-5C$2# was validated in accordance with internationally recognized safety and EMC standards by independent testing facilities. Additionally, EIZO GmbH performed a range of system and performance tests to ensure that the 5MP Grayscale Flat Panel Display performed in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance of a 5MP grayscale flat panel display.
While the predicate devices are specified to operate with proprietary display controllers such as the BarcoMed Nio or BarcoMed Coronis boards, the 6GF6201-5C$2# was designed to receive and display images from standard, commercial DVI display controllers.
The 6GF6201-5C$2# can be used in coniunction with the SMfit Total Care software package to select an internal lookup table, display test patterns, calibrate the display and view additional information about the display and peripheral devices such as external photometers.
9. Conclusion
The 5MP Grayscale Flat Panel Display is substantially equivalent to the predicate devices with respect to technical characteristics, application and intended use. Major components are the same, and those that are different have been validated, both the independent testing and internal performance tests. Any differences between the devices do not affect safety or effectiveness.
The 510(k) Pre-Market Notification for the 6GF6201-5C$2# contains sufficient information and data to enable FDA - CDRH to determine substantial equivalence to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is depicted with three distinct, curved lines that form the shape of the snakes and staff. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2008
Mr. James Berge Product Manager EIZO GmbH Siemensallee 84, Karlsruhe, 76187 GERMANY
Re: K081357
Trade/Device Name: 5MP Grayscale Flat Panel Display, Model: 6GF6201-5C$2# (Where $ = A-Z and # = 0-9) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 29, 2008 Received: August 6, 2008
Dear Mr. Berge:
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.
3
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/cdrh/industry/support/index.html.
Sincerely yours,
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K081357
| Device Name: | 5MP Grayscale Flat Panel Display
Model: 6GF6201-5C$2# (where $ = A-Z and # = 0-9) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | The 5MP Grayscale Flat Panel Display is intended to
be used in displaying and viewing digital images,
including digital mammography, for review, analysis
and diagnosis by trained medical practitioners. |
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Julia Lemus
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
Page 1 of _ 1