KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345

K051258 · Eastman Kodak Company · KPR · Jun 1, 2005 · Radiology

Device Facts

• Record ID: K051258
• Device Name: KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345
• Applicant: Eastman Kodak Company
• Product Code: KPR · Radiology
• Decision Date: Jun 1, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The KODAK DirectView DR 7500 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 7500 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. It functions as a standard radiographic imaging platform, capturing x-ray data to assist clinicians in diagnostic evaluations. The output is a digital radiographic image used for clinical decision-making regarding patient anatomy and pathology.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stationary diagnostic x-ray system. Class II device under 21 CFR 892.1680. Product codes KPR and MQB.

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

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

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

AUG 2 0 2013

Re: K051258

Trade/Device Name: Kodak Direct View DR 7500 System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MQB Dated: May 13, 2005 Received: May 18. 2005

Dear Ms. Ehmann:

This letter corrects our substantially equivalent letter of June 1, 2005.

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 nredicate 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Kodak DirectView DR 7500 System

ATTACHMENT I 510(k): Eastman Kodak Company

## Statement of Intended Use

510(k) Number (if known): KOS1258

Device Name: Kodak DirectView DR 7500 System

Intended Use and Indications for Use:

The KODAK DirectView DR 7500 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

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Prescription Use (per 21 CFR 801.109) OR

Over-the counter use

Rata Pease

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number k051258