(78 days)
Not Found
No
The summary describes a digital image display monitor and does not mention any AI or ML capabilities.
No
The device is described as a digital image display for medical imaging, not a device that directly treats a condition or disease.
No
The device is a digital image display intended for medical image applications. It displays medical images but does not perform diagnostic functions itself; rather, it is a tool used by a diagnostician. The predicate device is also a monitor.
No
The device description explicitly states it is a "digital image display" and a "5 Megapixel medical imaging" device, which are hardware components.
Based on the provided information, the RadiForce GS510 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "various kinds of medical image applications including digital mammography system." This describes a device used to display medical images, which are typically generated from imaging modalities like X-rays, CT scans, or MRI. IVD devices, on the other hand, are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
- Device Description: The description confirms it's a "digital image display." This aligns with the function of a medical monitor, not an IVD device.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological specimens.
- Using reagents or assays.
- Providing diagnostic information based on laboratory tests.
The RadiForce GS510 is a medical device, specifically a medical display monitor, but its function is to present images for interpretation, not to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
RadiForce GS510 is intended to be used in various kinds of medical image applications including digital mammography system for which the device complies with the performance specified by the manufacturer of the system.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
RadiForce GS510 device is a digital image display. G51 displays high-definition (5 Megapixel) medical imaging.
Mentions image processing
Not Found
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
OCT - 6 2006
-
- Company Identification
EIZO NANAO CORPORATION 153 Shimokashiwano cho, Hakusan, Ishikawa ken, 924-8566, Japan Tel: +81-76-274-2468 Fax: +81-76-274-2484
- Company Identification
-
- Official Correspondent
Hiroaki Hashimoto (Mr.) Manager of Engineering Management Section
- Official Correspondent
-
- Date of Submission
July 3, 2006
- Date of Submission
-
- Device Trade name RadiForce GS510, 5 Megapixel Monochrome LCD Monitor
-
- Common/Usual Name:
Image display system, medical image workstation, image monitor/display, and others
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- Classification Number:
Medical displays classified in Class II per 21 CFR 892.2050.
- Classification Number:
7. Predicate Device
| Manufacturer | EIZO NANAO CORPORATION |
|---|---|
| Device Name | 5 Megapixel Monochrome LCD Monitor |
| Model Name | RadiForce G51 |
| 510(k) No. | K042755 |
-
- Description of Device
RadiForce GS510 device is a digital image display. G51 displays high-definition (5 Megapixel) medical imaging.
- Description of Device
-
- Intended Use
RadiForce GS510 is intended to be used in various kinds of medical image applications including digital mammography system for which the device complies with the performance specified by the manufacturer of the system.
- Intended Use
-
- Substantial Equivalence to Predicate Device
RadiForce GS510 is substantially equivalent to G51. GS510 employs the maximum resolution values same as that of G51. Additional product innovations include Digital Uniformity Equalizer (DUE), which enables compensates for luminance non-uniformity. Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1.
- Substantial Equivalence to Predicate Device
1
Image /page/1/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 features a staff with a snake winding around it, and three horizontal bars above it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT - 6 2006
Eizo Nanao Corporation c/o Koji Kubo Medical Device Division Cosmos Corporation 319 Akeno, Obata-cho Ise-shi, Mie-ken, 519-0501 JAPAN
Re: K062054
Trade/Device Name: 5 Megapixel Monochrome LCD Monitor, RadiForce GS510 Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system '' Regulatory Class: II Product Code: LLZ Dated: September 4, 2006 Received: September 8, 2006
Dear Mr. Kubo:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o no review a your a your we device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce asio 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 A proval), 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/1/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the circle. The letters "FDA" are in the center of the circle. The word "Centennial" is below the letters. There are three stars below the word "Centennial."
ing and Promoting Public 9
2
Page 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 $10(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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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Indications for Use
510(k) Number (if known):
Device Name: RadiForce GS510
Indications For Use:
RadiForce GS510 is intended to be used in various kinds of medical image applications including digital mammography system for which the device complies with the performance specified by the manufacturer of the 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)
David b. Sygm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.