KODAK DIRECTVIEW DR SYSTEM DETECTOR

K051483 · Eastman Kodak Company · MQB · Jun 21, 2005 · Radiology

Device Facts

• Record ID: K051483
• Device Name: KODAK DIRECTVIEW DR SYSTEM DETECTOR
• Applicant: Eastman Kodak Company
• Product Code: MQB · Radiology
• Decision Date: Jun 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The KODAK DirectView DR System Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional screen-film systems may be used.

Device Story

Kodak DirectView DR System Detector captures radiographic images of human anatomy; intended as a digital replacement for conventional screen-film systems. Device functions as an image receptor in general projection radiography. Operated by radiology technologists in clinical settings. Input consists of X-ray radiation; output is a digital radiographic image displayed for physician review. Facilitates diagnostic imaging by providing digital image acquisition, replacing traditional film-based workflows. Benefits include improved workflow efficiency and digital image management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital X-ray detector for general projection radiography. Functions as an image receptor replacing screen-film systems. Regulated under 21 CFR 892.1630 (Electrostatic x-ray imaging system).

Indications for Use

Indicated for capturing radiographic images of human anatomy in general projection radiographic applications where conventional screen-film systems are used.

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 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051483 Trade/Device Name: Kodak DirectView System Detector Regulation Number: 21 CFR 892.1630 Regulation Name: Electrostatic x-ray imaging system . Regulatory Class: II Product Code: MQB Dated: June 3, 2005 Received: June 6, 2005

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 the chercoacy to the enactment date of the Medical Device Amendments, or to devices that have been rear 20, 1710, and classes 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 do not roquire approval or a provisions of the Act. The general controls provisions of the Act device, subjoct to the general 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 11 your device 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 statues 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) (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

JUN 2 1 2005

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This letter will allow you to begin marketing your device as described in your Section 510(k)
The States of the Caline of a line of a location to tiet aggivelance of your dev This letter will allow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial securedaries and thu premarket notification. The FDA Inding of substantial or 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 If you desire spectific advice for your device of our laboring 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 Also, please note the regulation Childer, "First. "First. And 1990 - 1990 - 1990 - 1990 - 1999 - 1999 - 1999 807.97). You may obtain other geleral monnal and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address 096-2011 07 (21 go v/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy 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 System Detector

## Indications for Use Statement

| 510(k) Number (if known): | K051483 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Kodak DirectView System Detector |
| Intended Use and Indications for Use: | The KODAK DirectView DR System Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional screen-film systems may be used. |

## Concurrence of CDRH, Office of Device Evaluation

Prescription Use (per 21 CFR 801.109) OR

Over-the counter use_

Nancy Brogdon

(Division Sign-Off) (Division Sign-Onlyn-Only Abdol
Division of Reproductive, Abdol
Division of Reproductives Division of Roprocession and Radiological Devices 510(k) Number -