(14 days)
Not Found
No
The description focuses on the monitor's display capabilities and technical specifications, with no mention of AI or ML for image analysis or processing.
No.
The device is a monitor used for displaying medical images for diagnosis, not for providing therapy directly.
No
This device is a monitor used to display images for diagnosis, but it does not perform the diagnostic function itself. It's a component of a diagnostic system rather than a diagnostic device.
No
The device description explicitly states it is a "monochrome LCD monitor" and mentions hardware components like a USB function and an optional photo-sensor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "displaying for diagnosis of X-ray or MRI etc." This describes a device that presents medical images for interpretation by a healthcare professional.
- Device Description: The description reinforces this by stating it's a "monochrome LCD monitor for medical use" and is "usually used to display for X-ray diagnosis or MRI."
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This monitor does not interact with biological specimens or perform any analysis on them.
The device is a medical imaging display, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The FC-2091 monochrome LCD monitor is intended to use in displaying for diagnosis of X-ray or MRI etc.
Product codes
90 LLZ
Device Description
FC-2091 is 20.8 inches class monochrome LCD monitor for medical use. This monitor is usually used to display for X-ray diagnosis or MRI. such as one of the medical diagnosis system. This model has specification of resolution in 2048 x 1536 or 2048 x 1536 . And this model has the USB function and optional photo-sensor DTP92 made by X rite Incorporated. This model is certified IEC60601-1 for medical safety standard.
Optional digital video card was designed exclusively for FC-2091. Type of digital video card is VR Engine MD3 by RealVision Inc. This video card for FC-2091 is sold separately. but FC-2091 support the digital video signal for only VR Engine MD3.
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
Not Found
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
Not Found
Key Metrics
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
JUL 12 2002
10. 510(k) Summary
。
参考文献
KO22109
as required by 807.92
-
- Company Identification
Submitter name : EIZO NANAO CORPORATION Address : 153. Shimokashiwano. Matto. Ishikawa. 924-8566. Japan Tel :481-76-274-2468 :+81-76-274-2484 Fax
- Company Identification
-
- Official Correspondent
Hiroaki Hashimoto (Mr.) Manager, engineering management section
- Official Correspondent
-
Date of Submission న్న
February 4. 2002 -
- Device trade name
20.8 inch class monochrome LCD monitor
- Device trade name
-
- Common name
Monitor
- Common name
-
- Classification
Medical displays were classified in class II (21 CFR 890.2050)
- Classification
-
Intended use The FC-2091 monochrome LCD monitor is intended to use in displaying for diagnosis of X-rav or MRI etc.
-
Predicate Device
Manufacturer: Totoku Electric Co.. Ltd. MONOCHROME PERFECTLY FLAT PANEL DISPLAYS Device name: ME311L:510(k) No.: K012099) Model name : Gray scale tones: 1021tones
-
- Comparison of technological characteristics between new device and predicate device
Please refer to the attachment Appendix.3.
- Comparison of technological characteristics between new device and predicate device
1
Appendix. 3
Comparison table with predicate device
| Item | FC-2091 (EIZO) | ME311L (Totoku) |
|---|---|---|
| 510(k) number | K012099 | |
| Technological characteristics | ||
| LCD inches | 20.8 inches | 20.8 inches |
| LCD surface | AG coating | AG coating |
| Display area | 423.9mm x 318mm | 423.9mm x 318mm |
| Input signal | ||
| (Digital) | TMDS | |
| (Single Link) | GVTF | |
| (10214-1210VE) | ||
| Screen resolution | 2048 x 1536 or | |
| 1536 x 2048 | 2048 x 1536 or | |
| 1536 x 2048 | ||
| Gray-scale display | 1531 tones (10.5bit) | |
| (In accordance with DICOM | ||
| Part 14) | 1021 tones | |
| Luminance | Max.650[cd/m²] | 600[cd/m²] or more |
| Luminance calibration | •Software (Option) | |
| •Photo-sensor (Option) | ||
| [model DTP92:X-rite] | ||
| • Protection panel (Option) | •Software (Option) | |
| •Photo-sensor (Option) | ||
| [model DTP92:X-rite] | ||
| •Photo-sensor holder | ||
| (Option) | ||
| Connector | DVI-D x1 | |
| USB 1up. 2down | ||
| Serial (mini DIN 6pin) | ||
| Serial (D-sub 9pin) | ||
| Sensor serial port: | ||
| (mini DIN 8pin) | D-sub (9pin) x2 | |
| USB 1up. 2down | ||
| Dimensions | ||
| (W x H x D [mm]) | 474 x 368 x 84[mm] | |
| (Approx.) | 486 x 480 x 250[mm] | |
| (Approx.) | ||
| Weight [kg] | 9.5kg | 11kg |
| Power | AC 100-120V/200-240V | |
| 50/60Hz Max. 95W | AC100-240V 50/60Hz | |
| Normally approx. 70W | ||
| Complied Standard | IEC60601-1 | |
| UL2601-1 | ||
| CSA No.601-1 | ||
| MDD/CE | ||
| (EN60601-1/EN60601-1-2) | ||
| FCC class A | ||
| VCCI class A | Safety: | |
| IEC60601-1 | ||
| UL2601-1 | ||
| CSA No.601-1 | ||
| MDD/CE (EN60601-1) | ||
| FDA510(k) | ||
| EMC: | ||
| FCC class A | ||
| VCCI class A | ||
| BSMI (CNS13438/C6357) |
Eizo's FC-2091 is different compared to a predicate device. Totoku ME311L in difference of built-in circuit of power supply instead of AC adapter. Looking at two models' outside. the shape of stand and connector and the number of connectors. However, the basic structure of the both models are the same in terms of consisting of LCD display and stand, and they are capable for use in portrait mode.
Totoku ME311L adopts GVIF for transmission method for digital video signal but Eizo FC-2091 adopts TMDS method. Eizo's FC-2091 has specification of resolution in 2048[H]× 15:36[V] in landscape mode or 15:36[H]×2048[V] in portrait mode.
Eizo FC-2091 converts inputted 8bit video signal into 10,5bit by mean of its ASIC, and this results in displaying maximum of 1531 scales while Totoku ME311L only displays 1021 scales. Eizo's FC-2091 1s able to display grayscale tones that is based on DICOM part14.
2
10. Description Device
FC-2091 is 20.8 inches class monochrome LCD monitor for medical use.
This monitor is usually used to display for X-ray diagnosis or MRI. such as one of the medical diagnosis system. This model has specification of resolution in 2048 × 1536 or 2048 × 1536 . And this model has the USB function and optional photo-sensor DTP92 made by X rite Incorporated. This model is certified IEC60601-1 for medical safety standard.
Optional digital video card was designed exclusively for FC-2091. Type of digital video card is VR Engine MD3 by RealVision Inc. This video card for FC-2091 is sold separately. but FC-2091 support the digital video signal for only VR Engine MD3.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing to the right, arranged in a stacked formation. The profiles are abstract and created with thick, curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the top half of the image.
(JUL 12 2002
Eizo Nanao Corp. % Mr. Wolfram Gmelin Technical Manager TÜV Rheinland of North America 12 Commerce Road NEWTON CT 06470
Re: K022109
Trade/Device Name: 20.8 inch monochrome LCD monitor (Model FC-2091) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: June 20, 2002 Received: June 28, 2002
Dear Mr. Gmelin:
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); 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.
4
This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4610 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
. 1
STATEMENT OF INTENDED USE
510(k) Number (if known): Device Name:_20.8 inch Monochrome LCD Monitor
Indications for Use:
The FC-2091 monochrome LCD monitor is intended to use in displaying for diagnosis of X-ray or MRI etc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Prescription Use
David A. Beeson
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _