FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR

K093427 · Fujifilm Medical System U.S.A., Inc. · MQB · Jan 21, 2010 · Radiology

Device Facts

• Record ID: K093427
• Device Name: FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR
• Applicant: Fujifilm Medical System U.S.A., Inc.
• Product Code: MQB · Radiology
• Decision Date: Jan 21, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The FDR AcSelerate system is a configurable stationary overhead X-ray tube and stand/table system intended to be used by a qualified/trained doctor or technologist for taking general radiographic and tomographic exposures of the whole body. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. The FDR AcSelerate is not intended for mammography. The FDR AcSelerate uses an integrated digital detector for generating diagnostic images by converting X-rays into electronic signals.

Device Story

FDR AcSelerate is a stationary overhead X-ray system; replaces film/screen systems for general-purpose diagnostic procedures. System inputs: X-ray radiation; integrated digital detector converts X-rays into electronic signals. Outputs: diagnostic radiographic and tomographic images. Used in clinical settings by trained doctors or technologists. Healthcare providers use images for diagnostic decision-making. Benefits include digital image acquisition and workflow efficiency.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stationary overhead X-ray tube and stand/table system; integrated digital detector for X-ray to electronic signal conversion. Configurable design for general-purpose diagnostic procedures.

Indications for Use

Indicated for general radiographic and tomographic exposures of the whole body in patients requiring diagnostic imaging. Contraindicated for mammography.

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 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

## FEB 2 2 2010

Ms. Debra A. Peacock Regulatory Coordinator FujiFilm Systems, USA Inc. 419 West Avenue STAMFORD CT 06902

Re: K093427

Trade/Device Name: FDR AcSelerate Stationary X-ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: October 30, 2009 Received: November 3, 2009

Dear Ms. Peacock:

This letter corrects our substantially equivalent letter of January 21, 2010.

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

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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 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 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 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 vours.

David YHR

Donald J. St.Pierre 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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## Indications for Use

510(k) Number (if known): K093427

Device Name: FDR AcSelerate Stationary X-ray System

Indications for Use:

The FDR AcSelerate system is a configurable stationary overhead X-ray tube and stand/table system intended to be used by a qualified/trained doctor or technologist for taking general radiographic and tomographic exposures of the whole body. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. The FDR AcSelerate is not intended for mammography. The FDR AcSelerate uses an integrated digital detector for generating diagnostic images by converting X-rays into electronic signals.

Prescription Use X Prescription Use______________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use (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) DIVD

Daniel H. Boles

(Division Sign-Off) Division of Radiological Devices

510(k) Number K093427