DDRELEMENT

K110828 · Swissray Medical AG · KPR · Aug 23, 2011 · Radiology

Device Facts

• Record ID: K110828
• Device Name: DDRELEMENT
• Applicant: Swissray Medical AG
• Product Code: KPR · Radiology
• Decision Date: Aug 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The ddRElement is a Digital Radiography system developed to be used for Medical General Radiography examinations on standing, seated and supine patients.

Device Story

ddR Element is a stationary digital radiography system; captures X-ray images of patients in standing, seated, or supine positions. System utilizes digital detectors to convert X-ray radiation into digital image data. Operated by trained radiologic technologists in clinical settings. Output consists of diagnostic-quality radiographic images displayed on a workstation for physician review. Facilitates clinical decision-making by providing anatomical visualization for diagnostic purposes. Benefits include rapid image acquisition and digital processing compared to traditional film-based systems.

Clinical Evidence

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

Technological Characteristics

Stationary digital radiography system; utilizes digital X-ray detectors. Operates as a general-purpose radiographic imaging system. Connectivity via standard digital imaging interfaces. System is designed for clinical environments.

Indications for Use

Indicated for medical general radiography examinations on standing, seated, and supine patients. Prescription use only.

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

Swissray Medical AG % Mr. John Monahan Official Correspondent Swissray International. Inc. One Tower Center EAST BRUNSWICK NJ 08816

AUG 2 0 2013

Re: K110828

Trade/Device Name: ddR Element Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: August 2. 2011 Received: August 4, 2011

Dear Mr. Monahan:

This letter corrects our substantially equivalent letter of August 23, 2011.

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 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 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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## ndications for Use Form (Text Version)

ndications for Use

510(k) Number (if known) K110828

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indications for USe . The ddRElement is a Digital Radiography.system developed to be used for Medical
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