INFIMED DENTAL SYSTEM

K962422 · Infimed, Inc. · EHD · Sep 11, 1997 · Dental

Device Facts

• Record ID: K962422
• Device Name: INFIMED DENTAL SYSTEM
• Applicant: Infimed, Inc.
• Product Code: EHD · Dental
• Decision Date: Sep 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended 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.

Device Story

InfiMed Dental System is an image acquisition and management system for dental clinics. Inputs include color images from standard S-video cameras and radiographs from a custom Charge Injection Device (CID) sensor. System components facilitate image acquisition, storage, display, and printing. Images can be processed on a personal computer using dental image management software for patient data input and display. Output consists of digital images on computer monitors, printed reports, or S-video equipment displays. Used by dental professionals to assist in clinical documentation and patient management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System utilizes a Charge Injection Device (CID) sensor for radiograph acquisition and standard S-video interfaces for color image input. Operates via personal computer integration for image management, processing, and display. Connectivity includes S-video equipment and PC-based storage/printing.

Indications for Use

Indicated for dental patients requiring acquisition, processing, display, and printing of filmless radiographs and color dental images. Prescription use only.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

SEP 11 1997

Morteza Minaee
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. Minaee:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device 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 Amendments, or to devices 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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) 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑
OR Over-the-Counter Use ☐
(Optional Format 1-2-96)

(Per 21 CFR 801.109)

David G. Segman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K962422