KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM

K060079 · Eastman Kodak Company · MUH · Feb 8, 2006 · Dental

Device Facts

• Record ID: K060079
• Device Name: KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM
• Applicant: Eastman Kodak Company
• Product Code: MUH · Dental
• Decision Date: Feb 8, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The KODAK CR-7400 Digital Radiography System is intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral images.

Device Story

KODAK CR 7400 is a digital dental radiography system; utilizes phosphor storage screens to capture X-ray images; system processes latent images from screens into digital format for diagnostic review; intended for use in dental clinical settings by trained professionals; output displayed on workstation monitors for clinical assessment; facilitates diagnosis of dental conditions; benefits include transition from analog film to digital workflow, enabling image enhancement, storage, and efficient retrieval.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on bench testing and technical comparison to legally marketed predicate devices.

Technological Characteristics

Digital radiography system using phosphor storage screens; intraoral and extraoral imaging capability; standalone workstation-based processing; complies with 21 CFR 872.1800 (Extraoral source x-ray system).

Indications for Use

Indicated for patients requiring dental radiographic diagnostic imaging, both intraoral and extraoral, using phosphor storage screen technology.

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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized graphic of an abstract human figure with three flowing lines emanating from it, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

FEB 8 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ravi Nabar, Ph.D., CIH Regulatory Affairs & Validation Manager Kodak Health Group Eastman Kodak Company 343 State Street ROCHESTER NY 14650

Re: K060079

Trade/Device Name: KODAK CR 7400 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: January 9, 2006 Received: January 10, 2006

Dear Dr. Nabar:

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.

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.

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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 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 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

DEVICE NAME: KODAK CR 7400

INDICATION FOR USE: The KODAK CR-7400 Digital Radiography System is intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral images.

(Please do not write below this line - continue on another page if needed)

( Concurrence of CDRH, Office of Device Evaluation (ODE) )

Prescription Use: YES (Per 21 CFR 801.109)

:

OR Over-the-Counter Use: NO

Daniel h. Segerson

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
`K060079