(24 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 a digital image display for medical images, not a device that directly treats or diagnoses a medical condition. Its function is to present images, similar to a monitor.
Yes
The device is a digital image display intended for "medical image applications including digital mammography system." Displaying medical images for diagnostic purposes makes it a diagnostic device. The predicate device also supports this, as it is a "5 Megapixel Monochrome LCD Monitor."
No
The device description explicitly states it is a "digital image display," which is a hardware component (a monitor).
Based on the provided information, the RadiForce GS520 is not an IVD (In Vitro Diagnostic).
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 images generated from the body, not a device used to examine specimens taken from the body (which is the core function of an IVD).
- Device Description: It's described as a "digital image display." This is a display device, not a diagnostic test that analyzes biological samples.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, reagents, or performing tests on specimens.
IVDs are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The RadiForce GS520 is a display device for medical images, which are generated by imaging modalities like X-ray or mammography.
Therefore, the RadiForce GS520 falls under the category of a medical image display device, not an IVD.
N/A
Intended Use / Indications for Use
RadiForce GS520 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 GS520 device is a digital image display. G520 displays high-definition (5 Megapixel) medical imaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical imaging
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)
Electrical Safety and the Electrical Compatibility (EMC) Testing were performed. The certification of UL 60601-1:2003 and EMC Test report were included in this 510(k) submission.
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
MAR 1 0 2008
- Company Identification
EIZO NANAO CORPORATION 153 Shimokashiwano-cho, Hakusan, Ishikawa-ken, 924-8566, Japan Tel: +81-76-274-2468 Fax: +81-76-274-2484
-
- Official Correspondent
Hiroaki Hashimoto (Mr.) Manager of Engineering Management Section
- Official Correspondent
-
- Date of Submission
February 14, 2008
- Date of Submission
-
- Device Trade name 5 Megapixel Monochrome LCD Monitor, RadiForce GS520
-
- 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.
- Classification Number:
-
- Predicate Device
| Manufacturer | : EIZO NANAO CORPORATION | |
|---|---|---|
| Device Name | : 5 Megapixel Monochrome LCD Monitor | |
| Model Name | : RadiForce GS510 | |
| 510(k) No. | : K062054 |
-
- Description of Device
RadiForce GS520 device is a digital image display. G520 displays high-definition (5 Megapixel) medical imaging.
- Description of Device
-
- Intended Use
RadiForce GS520 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
GS520 employs the maximum RadiForce GS520 is substantially equivalent to GS510. resolution values same as that of GS510. GS520 changed the Power Supply. We performed the Electrical Safety and the Electrical Compatibility (EMC) Testing. The certification of UL 60601-1:2003 and EMC Test report were included in this 510(k) submission. The software is modified. Revised the Software Information is included.
- Substantial Equivalence to Predicate Device
Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1.
1
Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The background is white. The text is centered in the image.
Image /page/1/Picture/12 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 forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Hiroaki Hashimoto Manager Eizo Nanao Corporation Engineering Management Section 153 Shimokashiwano-cho Hakusan, Ishikawa-ken JAPAN 924-8566
MAR 1 0 2008
Re: K080422
Trade/Device Name: 5 Megapixel Monochrome LCD Monitor (RadiForce GS520) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 14, 2008 Received: February 15, 2008
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/1/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo. The word "Centennial" is below the letters. There are stars and other symbols around the perimeter of the circle.
Protecting and Promoting Public Health.
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 (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.
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" (21 CFR 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/cdrb/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known): Notknown K080422
Device Name : 5 Megapixe! Monochrome LCD Monitor, RadiForce GS520
Indications for Use:
RadiForce GS520 is intended to be used in various kinds of medical image applications including digital mammography system for which the device complies with performance specified by the manufacture of the system.
Prescription Use X (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)
(Division Sign-Off)
Reproductive, Abdomina and Radiological Devices 510(k) Number