KODAK ECLIPSE IMAGE PROCESSING SOFTWARE

K060137 · Eastman Kodak Company · MQB · Mar 16, 2006 · Radiology

Device Facts

• Record ID: K060137
• Device Name: KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
• Applicant: Eastman Kodak Company
• Product Code: MQB · Radiology
• Decision Date: Mar 16, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The CR Systems are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiography applications. This excludes mammography applications for the Kodak Ektascan Storage Phosphor Reader and the Kodak Eclipse Image Processing Software in the United States.

Device Story

Kodak Eclipse Image Processing Software functions as part of CR systems; processes latent images captured on storage phosphor imaging plates via laser scanners. Software transforms raw scanned data into digital images for projection radiography. Used in clinical settings by radiology professionals. Output viewed by clinicians to assist in diagnostic imaging interpretation. Benefits include conversion of analog storage phosphor data into digital format for standard radiographic procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Software-based image processing for CR systems; operates on digital data derived from storage phosphor imaging plates. Designed for projection radiography; excludes mammography.

Indications for Use

Indicated for use in projection radiography applications to produce digital images from storage phosphor imaging plates. Excludes mammography applications.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 2005

Ms. Linda Stewart Regulatory Affairs Director Eastman Kodak Company Health Group 343 State Street ROCHESTER NY 14650

Re: K060137

Trade/Device Name: Kodak Eclipse Image processing software Regulation Number: 21 CFR 892.1630 Regulation Name: Solid state x-ray imaging system Regulatory Class: II Product Code: MOB Dated: February 21, 2006 Received: February 22, 2006

Dear Ms. Stewart:

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 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 marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

ff 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 vours.

Nancy C. Brigdon

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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Anachment 3 Special 510(k): Eastman Kodak Company

## Indications for Use

510(k) Number (if known): K060137

Device Name: Kodak Eclipse Image Processing Software

Indications for Use:

The CR Systems are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiography applications. This excludes mammography applications for the Kodak Ektascan Storage Phosphor Reader and the Kodak Eclipse Image Processing Software in the United States.

Over-The-Counter Use Prescription Use X Prescription Ose _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel br. beyram

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

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