KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386

K060550 · Eastman Kodak Company · KPR · Mar 31, 2006 · Radiology

Device Facts

• Record ID: K060550
• Device Name: KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386
• Applicant: Eastman Kodak Company
• Product Code: KPR · Radiology
• Decision Date: Mar 31, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The KODAK DirectView DR 3000 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

Device Story

The Kodak DirectView DR 3000 System is a stationary diagnostic x-ray system. It generates x-rays to produce radiographic images of various anatomical regions. The system is intended for use in clinical settings by trained healthcare professionals. The output consists of diagnostic images used by radiologists and clinicians to evaluate patient anatomy and pathology, facilitating clinical decision-making and diagnosis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stationary diagnostic x-ray system. Operates under 21 CFR 892.1680. Class II device. Product code KPR.

Indications for Use

Indicated for diagnostic x-ray imaging of various anatomical regions in patients requiring radiographic examination.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Submission Summary (Full Text)

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Public Health Service

MAR 3 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Christine E. Ehmann Regulatory Affairs Manager Kodak Health Group Eastman Kodak Company 343 State Street ROCHESTER NY 14650

Re: K060550

Trade/Device Name: Kodak Direct View DR 3000 System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: February 28, 2006 Received: March 2, 2006

Dear Ms. Ehmann:

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 vour 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 clectronic 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 premated 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. Brigdon

Namev 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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Kodak DirectView DR 3000 System

## Statement of Intended Use

510(k) Number (if known):

Device Name:

Intended Use and Indications for Use:

1760550 Kodak DirectView DR 3000 System

The KODAK DirectView DR 3000 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

Concurrence of CDRH, Office of Device Evaluation

ﺮ Prescription Use_ (per 21 CFR 801.109)

OR

Over-the counter use_

Daniel A. Sypnem
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices り!(火)Number