(58 days)
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Not Found
No
The document describes a monochrome LCD monitor for displaying medical images and does not mention any AI/ML capabilities or related performance data.
No
Explanation: The device is a monitor intended for displaying medical images for diagnosis, not for providing therapy.
No
The device is a monitor intended for displaying images, not for performing the diagnosis itself. Diagnosis is done by a human viewing the displayed images.
No
The device description explicitly states it is a "Monochrome LCD Monitor," which is a hardware component.
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 used to visualize medical images, which are generated from within the patient's body (in vivo).
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The device described is a monitor used to display images generated by other medical devices (X-ray, MRI). It does not perform any tests on biological samples.
N/A
Intended Use / Indications for Use
Monochrome LCD Monitor, RadiForce G11, G31 and G51 are intended to be used in displaying for diagnosis of X-ray or MRI, etc.
Product codes
90 LLZ
Device Description
46 cm (18.1 inch) Monochrome LCD Monitor, RadiForce G11
53 cm (20.8 inch) Monochrome LCD Monitor, RadiForce G31
54 cm (21.3 inch) Monochrome LCD Monitor, RadiForce G51
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray or MRI, etc.
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
SEP 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Hiroaki Hashimoto Manager, engineering Management Section Eizo Nanao Corporation 153 Shimokashiwano-cho, Matto-shi Ishikawa-ken, 924-8566 JAPAN
Re: K032026
Trade/Device Name: RadiForce G11, RadiForce G31, & RadiForce G51 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: August 4, 2003 Received: August 8, 2003
Dear Mr. Hashimoto:
This letter corrects our substantially equivalent letter of August 27, 2003 regarding the address and contact information.
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 (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
1
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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4564. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
David A. Sigsmon
N
Dr
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
June 25, 2003
INDICAITIONS FOR USE STATEMENT
510(k) Number (If known):
. .
Device Name
46 cm (18.1 inch) Monochrome LCD Monitor, RadiForce G11 53 cm (20.8 inch) Monochrome LCD Monitor, RadiForce G31 54 cm (21.3 inch) Monochrome LCD Monitor, RadiForce G51
Indications for Use:
Monochrome LCD Monitor, RadiForce G11, G31 and G51 are intended to be used 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 (Per 21CFR 801.109)
OR
Over-The-Counter Use_
Daniel A. Lyons
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number 032024