(169 days)
No
The document describes a medical display monitor with features for image display and calibration, but no mention of AI or ML for image analysis or processing.
No
The device is a display for viewing digital medical images and does not have a direct therapeutic function.
Yes
The "Device Description" explicitly states, "The 6GF6201-8CS## is a diagnostic 10MP gravscale flat panel display for viewing medical images." Additionally, its intended use is for "displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners," which supports its role in diagnostics.
No
The device description clearly details a physical hardware component (a flat panel display) with specific technical specifications, sensors, and housing. It is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of this device is to display and view digital images, including digital mammography, for review and analysis. It does not interact with or analyze biological samples.
- The device is a display. Its function is to present visual information (medical images) to a trained medical practitioner. It does not perform any diagnostic tests or analysis on biological material.
The description clearly indicates that this is a medical display for viewing images, which falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The 10MP Grayscale Flat Panel Display is intended to be used in displaying and wewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
Product codes
LLZ
Device Description
The 6GF6201-8CS## is a diagnostic 10MP gravscale flat panel display for viewing medical images. With the callbrated gamma response stored in five internal lookup tables, the display is suitable for use with a wide range of DV! graphic controller boards. The display is used in dual-head configuration.
The 10MP 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 4096 x 2560 pixels and is used in landscape mode. The display uses backlight sensor to automatically stabilize the set luminance levels of the CCFL backlight over time. It also sports an integrated front sensor 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 10MP Grayscale Flat Panel Display may be offerent housing colors and with different logos. These cosmetic differences are reflected in the designators represented by the characters "$" and "#" included in the model trade name 6GF6201-8C$#, where $ represents a letter between A and Z, and # is a number between 0 and 9.
The 10MP Grayscale Flat Panel Display uses the same LCD panel from the same manufactorer as the predicate device and employs CCFL backlight technology. It is equipped with two integrated luminance sensors, one mounted rear center and a built in front sensor, as included with the Coronis Fusion 10MP.
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 6GF6201-8C$## was validated in accordance with internationally recognized safety and EMC standards by independent testing facilities and inhouse. Additionally, EIZO GmbH performed a range of system and performance tests to ensure that the 10MP Grayscale Flat Panel Display performed in accordance with its specifications.
Mentions image processing
Yes
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)
EIZO GmbH performed a range of system and performance tests to ensure that the 10MP Grayscale Flat Panel Display performed in accordance with its specifications.
None of the tests revealed behaviors inconsistent with the expected performance of a 10MP grayscale flat panel display.
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).
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Image /page/0/Picture/0 description: The image shows the logo for EIZO. The logo consists of a stylized geometric shape above the word "EIZO". The geometric shape is a triangle with a stepped pattern along the bottom edge. The word "EIZO" is in a bold, sans-serif font.
| JUN | - 8 2011 |
|---|---|
| ----- | ---------- |
K103724
Eizo GmbH, Siemensallee 84, 76187 Karlsruhe
Food and Drug Administration
Center for Devices and Radiological Health (HFZ-401)
9200 Corporate Blvd.
Rockville, MD, USA
20850
| Name | Guenter Michael Volz |
|---|---|
| Department | RD |
| Telephone | +49 (721) 20321-282 |
| Fax | +49 (721) 20321-478 |
| guenter.volz@eizo.com | |
| Date | Nov 30, 2010 |
Abbreviated 510(k) Summary (in accordance with 21 CFR 807.92)
-
- Date of Summary Nov 30, 2010
-
- Company
EIZO GmbH Siemensallee 84 D-76187 Karlsruhe, Germany
-
- Authorized Contact Person Guenter Michael Volz
4. Device Information
- 6GF6201-8C$## (where $ = A-Z and # = 0-9) . Trade Name/Model:
- . Common Name: Display, 10MP Grayscale Flat Panel Display, GX1030
- Classification Name: System, Image Processing ●
- Classification Number: 21 CFR 892.2050, Product Code LLZ .
5. Predicate Device
- Coronis Fusion 10MP (MDCG-10130) (K093197) .
6. Device Description
The 6GF6201-8CS## is a diagnostic 10MP gravscale flat panel display for viewing medical images. With the callbrated gamma response stored in five internal lookup tables, the display is suitable for use with a wide range of DV! graphic controller boards. The display is used in dual-head configuration.
7. Intended Use
The 10MP Grayscale Flat Panel Display is intended to be used in displaying and wewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
8. Technological Characteristics
The 10MP 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 4096 x 2560 pixels and is used in landscape mode. The display uses backlight sensor to automatically stabilize the set luminance levels of the CCFL backlight over time. It also sports an integrated front sensor for independent grayscale
Office/Delivery address: Eizo GmbH Siemensallee 84 76187 Karlsruhe Tel .: +49 (721) 20321-0 Fax: +49 (721) 20321-471 Postal address: Eizo GmbH 76181 Karlsruhe Management Peter Ziegler
Internet: http://www.eizo.eu
Abbreviated_510(k) Summary
Section 5: Page 1 of 2
WEEE-Reg-Nr. DE 75807507
Commercial registries:
Mannheim HRB 703009
Kadsruhe
Registergericht:
1
Image /page/1/Picture/1 description: The image shows the logo for EIZO. The logo consists of a stylized geometric shape above the word "EIZO". The geometric shape is a triangle with a stepped or pixelated bottom edge, and a small square is present near the top of the triangle. The word "EIZO" is in a bold, sans-serif font.
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 10MP Grayscale Flat Panel Display may be offerent housing colors and with different logos. These cosmetic differences are reflected in the designators represented by the characters "$" and "#" included in the model trade name 6GF6201-8C$#, where $ represents a letter between A and Z, and # is a number between 0 and 9.
The 10MP Grayscale Flat Panel Display uses the same LCD panel from the same manufactorer as the predicate device and employs CCFL backlight technology. It is equipped with two integrated luminance sensors, one mounted rear center and a built in front sensor, as included with the Coronis Fusion 10MP.
i 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 6GF6201-8C$## was validated in accordance with internationally recognized safety and EMC standards by independent testing facilities and inhouse. Additionally, EIZO GmbH performed a range of system and performance tests to ensure that the 10MP Grayscale Flat Panel Display performed in accordance with its specifications.
A more detailed description is included in section 09 "Declaration of Conformity or Summary Report". The "Guidance for Industry: Guidance for the Submission Of Premarket Notifications for Medical Image Management Devices" applies to this abbreviated 510(k) submission.
None of the tests revealed behaviors inconsistent with the expected performance of a 10MP grayscale flat panel display.
While the predicate device is equipped with a proprietary high speed display controller, the 6GF6201-8CS## was designed to receive and display images from standard, commercial DVI display controllers.
9. Conclusion
. J
The 10MP Grayscale Flat Panel Display is substantially equivalent to the predicate device with respect to technical characteristics, application and intended use. Major components are the same, and those that are different have been validated, both in independent testing and internal performance tests. Any differences between the devices do not affect safety or effectiveness.
The 510(k) Premarket Notification for the 6GF6201-8C$## 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/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Günter M. Volz Project Manager EIZO GmbH Siemensallee 84. D-76187 Karlsruhe GERMANY
JUN - 8 2511
Re: K103724
Trade/Device Name: 10 MP Grayscale Flat Panel Display (GX1030) Model: 6GF6201-8C$## (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: April 21, 2011 Received: May 3, 2011
Dear Mr. Volz:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/cdrl/industry/support/index.html.
Sincerely Yours,
Mary Pastel
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K103724
Device Name:
10MP Grayscale Flat Panel Display (GX1030) Model: 6GF6201-8C$## (where $ = A-Z and # = 0-9)
Indications For Use:
The 10MP Grayscale Flat Panel Display (GX1030) is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
Prescription Use Yes (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ No (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)
Mary S Postell
Division S Division of Badiological De Office of In Vitro Diagnostic Device Evalu
510K K163794
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