(28 days)
Not Found
No
The summary describes a monochrome LCD display for viewing medical images and does not mention any AI or ML capabilities.
No
The device is a display for viewing medical images for diagnosis, not a device that directly treats or provides therapy to a patient.
No
Explanation: The device is a display for viewing digital images for diagnosis, but it is not performing the diagnostic function itself. It's a tool used in the diagnostic process.
No
The device description explicitly states it is a "Monochrome LCD display," which is a hardware component.
Based on the provided information, the RadiForce GS310 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.
- RadiForce GS310's Function: The RadiForce GS310 is a display device used for viewing digital medical images (X-ray, MRI, etc.). It does not perform any tests on biological samples. Its function is to present visual information generated by other medical devices.
- Intended Use: The intended use clearly states it's for "displaying and viewing digital images for diagnosis." This is a display function, not a diagnostic test performed on a sample.
Therefore, the RadiForce GS310 falls under the category of a medical image display device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
RadiForce GS310 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 GS310 is a 53cm (20.8") Monochrome LCD display for medical image viewing. GS310 displays high-definition 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)
Comparison table of the principal characteristics of 2 devices in Attachment 1 shows that new and predicate devices are substantially equivalent in the areas of technical characteristics, general functions.
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
510(k) Summary as required by 807.92
- Company Identification EIZO NANAO CORPORATION 153 Shimokashiwano-cho, Hakusan·shi, Ishikawa-ken, 924-8566, Japan Tel: +81-76-274-2468 Fax: +81-76-274-2484
APR 2 5 2006
-
- Official Correspondent Hiroaki Hashimoto (Mr.) Manager of Engineering Management Section
-
- Date of Submission March 22, 2006
-
- Device Trade name Monochrome LCD Monitor, RadiForce GS310
-
- 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.
-
- Predicate Device
- Manufacturer : EIZO NANAO CORPORATION : Monochrome LCD Monitor Device Name Model Name : RadiForce G33 510(k) No. : K052337
-
- Description of Device
RadiForce GS310 is a 53cm (20.8") Monochrome LCD display for medical image viewing. GS310 displays high-definition medical imaging.
-
- Intended Use
RadiForce GS310 is intended to be used in displaying and viewing digital images for diagnosis of Xray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.
- Intended Use
-
- Technological Characteristics
GS310 employs smaller grayscale tones than that of G33. The sole modification is 3 bit ratio in sub-pixel opening areas for GS310. Comparison table of the principal characteristics of 2 devices in Attachment 1 shows that new and predicate devices are substantially equivalent in the areas of technical characteristics, general functions.
- Technological Characteristics
1
Appendix 1: Comparison Table with Predicate Device
| Items | G33 | GS310 |
|---|---|---|
| 510(k) Number | K052337 | Not known |
| Panel Size and Type | 53 cm (20.8") TFT Monochrome | |
| LCD panel | 53 cm (20.8") TFT Monochrome | |
| LCD panel | ||
| Cabinet Color | Black | Black |
| Pixel Pitch | 0.207 x 0.207mm | 0.207 x 0.207mm |
| Ratio of Sub-pixel | 4: 2: 1 | 4: 4: 4 |
| Opening Areas | ||
| Grayscale Tones | 4,096 from a pallet of 8,161 | 1,024 from a pallet of 8,161 |
| Viewing Angles | H: 170°, V: 170° | H: 170°, V: 170° |
| Scanning Frequency | ||
| (H, V) | 31-100kHz, 48-71.5Hz | |
| (VGA Text: 69-71Hz) | ||
| Frame synchronous mode: 59-61Hz | 31-100kHz, 48-71.5Hz | |
| (VGA Text: 69-71Hz) | ||
| Frame synchronous mode: 59-61Hz | ||
| Native Resolutions | 1536 x 2048 (landscape) | |
| 1536 x 2048 (portrait) | 1536 x 2048 | |
| Brightness | 700 cd/m² (Typical) | 700 cd/m² (Typical) |
| Contrast Ratio | 700: 1 (typical) | 900: 1 (typical) |
| DOT Clock | 165 MHz | 165 MHz |
| Response Time | 50 ms (typical) | 50 ms (typical) |
| Active Display Size | ||
| (H x V) | 318 x 424 mm | 318 x 424 mm |
| Viewable Image Size | 529 mm (20.8") (diagonal) | 529 mm (20.8") (diagonal) |
| Luminance Calibration | Built-in swing calibration sensor | |
| provided. | Built-in swing calibration sensor | |
| provided. | ||
| Input Signals | DVI Standard 1.0 | DVI Standard 1.0 |
| Input Terminals | DVU-D 24 pin | DVU-D 24 pin |
| USB Ports / Standard | 1 upstream, 2 downstream | 1 upstream, 2 downstream |
| Power | AC100-120V, 200-240V, 50/60Hz | AC100-120V, 200-240V, 50/60Hz |
| Power Management | DVI-DMPM | DVI-DMPM |
| Dimensions (W x H x D) | With Stand: | |
| 368 x 515.5 mm |
- 597.5 x 209 mm
Without Stand:
368 x 486 x 90 mm | With Stand:
368 x 515.5 mm - 597.5 x 209 mm
Without Stand:
368 x 486 x 90 mm |
| Certifications &
Standards | TUV/GM, CE Medical Device
Directive, CB (EN60601-1),
cTUVus (UL2601-1, CSA C22.2 No.
601-1), VCCI-B, FCC-B, Canadian | TUV/GM, CE Medical Device
Directive, CB (EN60601-1),
cTUVus (UL2601-1, CSA C22.2 No.
601-1), VCCI-B, FCC-B, Canadian |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 2 5 2006
Mr. Hiroaki Hashimoto Manager EIZO NANAO Corporation Engineering Management Section 153 Shimokashiwano, Hakusan, Ishikawa, 924-8566 JAPAN
Re: K060845
Trade/Device Name: Monochrome LCD Monitor, RadiForce GS310 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 9, 2006 Received: March 28, 2006
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image shows a logo for the FDA Centennial 1906-2006. The logo is circular and contains the letters FDA in the center. The text "Protecting and Promoting Public Health" is written in a decorative font below the logo. The logo is black and white.
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 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" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/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
Enclosure
4
Indications for Use
510(k) Number (if known): Not known K 06084 >
Monochrome LCD Monitor, RadiForce GS310 Device Name :
Indications For Use:
RadiForce GS310 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.
Prescription Use _ (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)
Vancy C. Bunkin
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060845