(444 days)
The InfiMed Dental System is an image acquisition and management system that allows acquisition, processing, display, and print of filmless radiographs and/or color dental images. It consists of various components that acquire, store, display, and print radiographs and/or color dental images with patient information.
The InfiMed Dental System is an image acquisition and management system. Its capabilities include: Color image acquisition takes place from a standard S-video color camera. Radiograph acquisition takes place from a Charge Injection Device (CID) sensor custom designed for the application. Images can be directly printed and displayed on standard S-video equipment or transferred to a personal computer for acquisition and storage. If images are stored on the personal computer, dental image management software is utilized for patient data input, image processing, and image display on the computer monitor. In addition, printed reports are available from the personal computer.
The provided text from the FDA 510(k) premarket notification does not contain information regarding acceptance criteria, device performance studies, sample sizes, data provenance, ground truth establishment, or expert qualifications for the InfiMed Dental System.
The document is a letter from the FDA to InfiMed, Inc. confirming that their device, the "InfiMed Dental System" (K962422), has been found substantially equivalent to legally marketed predicate devices. It outlines the regulatory class, procode, and general controls applicable to the device.
The "Indications for Use" section describes the device's functionality: an image acquisition and management system for filmless radiographs and/or color dental images, consisting of components to acquire, store, display, and print these images with patient information. It details how color images are acquired (from a standard S-video color camera) and radiographs are acquired (from a Charge Injection Device (CID) sensor). It also mentions the capability for direct printing/display or transfer to a personal computer for acquisition, storage, patient data input, image processing, display, and printed reports.
Therefore, I cannot provide the requested information based on the given document.
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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 11 1997
Morteza Minace Manager Quality Assurance InfiMed, Inc. 121 Metropolitan Drive Liverpool, New York 13088 Re:
K962422 InfiMed Dental System Dated: July 31, 1997 Received: August 1, 1997 Regulatory class: II 21 CFR 872.1800/Procode: 90 EHD
Dear Mr. Minace:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have decermined the vice is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce or to May 28, 1976, the enactment date of the Medical Device that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registerion, 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 Coatrols) 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the Goff regulation may result in regulatory action. In addition, FDA may publish fiurther announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 809.10 for in yitro diamostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
H.T.Liau Yu
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K962422
Device Name: InfiMed Dental System
Indications for Use:
The InfiMed Dental System is an image acquisition and management system that allows acquisition, processing, display, and print of filmless radiographs and/or color dental images. It consists of various components that acquire, store, display, and print radiographs and/or color dental images with patient information.
Its capabilities include:
Color image acquisition takes place from a standard S-video color camera. Radiograph acquisition takes place from a Charge Injection Device (CID) seasor custom designed for the application. Images can be directly printed and displayed on standard S-video equipment or transferred to a personal computer for acquisition and storage. If images are stored on the personal computer, dental image management software is utilized for patient data input, image processing, and image display on the computer monitor. In addition, printed reports are available from the personal computer.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NERDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_$\mathbb{X}$ OR Over-the-Counter Use _
of the image is: Prescription Use_$\mathbb{X}$ OR Over-the-Counter Use _
the OCR of the image is: Prescription Use_$\mathbb{X}$ OR Over-the-Counter Use _
OTC. the Contact Coe.
(Optional Format 1-2-96)
(Per 21 CFR 801.109)
David be Seymon
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.