(112 days)
Color LCD Monitor, RadiForce R22 is intended to be used in displaying for diagnosis of Xrray or MRI, etc.
Color LCD Display, RadiForce R22
The provided document is a 510(k) clearance letter from the FDA for a medical device: "Color LCD Display, RadiForce R22." This letter confirms that the device has been found substantially equivalent to a legally marketed predicate device.
However, the document does not contain specific information regarding acceptance criteria for device performance, a study proving those criteria, or details such as sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies.
The document primarily states the device's intended use: "Color LCD Monitor, RadiForce R22 is intended to be used in displaying for diagnosis of X-ray or MRI, etc." It also lists the regulatory information and general controls applicable to such a device.
Therefore, I cannot provide the requested table and detailed study information based on the text provided. This kind of information is typically found in the 510(k) submission summary or technical documentation that the FDA reviews, but not in the clearance letter itself.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Hiroaki Hashimoto Eizo Nanao Corporation Engineering Management Section 153 Shimokashiwano-Cho Matt0-Shi, Ishikawa-Ken 924-8566
Re: K033466 Trade/Device Name: Color LCD Display, RadiForce R22 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: January 26, 2004 Received: January 30, 2004
Dear Mr. Hashimoto:
JAPAN
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 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.
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.
FEB 2 0 2004
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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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 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" (21CFR Part 807.97) you may obtain. 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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INDICAITIONS FOR USE STATEMENT
510(k) Number (If known): ___________________________________________________________________________________________________________________________________________________
Color LCD Monitor, RadiForce R22 " Device Name
Indications for Use
Color LCD Monitor, RadiForce R22 is intended to be used in displaying for diagnosis of Xrray or MRI, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
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Prescription Use
(Per 21CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Nancy C. Brodon
(Division Sign Off)
tive. Ahd and Radiological De 510(k) Number.
§ 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).